Download - Condition - Osmosis Skin Care
International Research Services, Inc.
CLINICAL RESEARCH REPORT
An Eight-Week Clinical Study to Evaluate the Efficacy of a Regimen of Topical Products on Skin Condition
Protocol Number: 3931OSM0415
Sponsor: Osmosis, LLC
Issued To: Ben Johnson, MD CEO Osmosis, LLC 30746 Bryant Drive Unit #410 Evergreen, CO 80439 Phone: 303.674.7660 E-Mail: [email protected]
Date of Issue: October 21, 2015
Study Site:
International Research Services, Inc. 222 Grace Church Street Port Chester, NY 10573 Phone: 914.937.6500 Fax: 914.937.8067
Stephen R. Schwartz IRSI President, CEO E-Mail: [email protected]
Principal Investigator:
Robert J. Frumento IRSI VP Clinical and Corporate Operations E-Mail: [email protected]
Study Coordinator:
Robigaile W. Atienza, CCRC IRSI Study Coordinator E-Mail: [email protected]
Study Schedule Initiation: Screening/ Washout June 8, 2015
Completion: Week 8 August 10, 2015
Product: Purify #OS-PRD-PUR-200; Catalyst AC–11 #OS-PRD-CAC-030; Spritz Clear Plus #OS-PRD-CLR-100; Quench Plus #OS-PRD-QUE-031
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Study Summary
Title An Eight-Week Clinical Study to Evaluate the Efficacy of a Regimen of Topical Products on Skin Condition
Protocol Number 3931OSM0415
Sponsor Osmosis, LLC
Methodology Monadic
Objective To evaluate the efficacy of one product to improve skin appearance and condition
Number of Subjects 30 to complete, target enrollment 35
Target Population Female subjects, age 35-59 years old
Duration 8 Weeks + 1 week washout (Screening/Washout (T-7D), Baseline, Week 1, Week 4, Week 8)
Claims
Claims to be assessed immediately after application of the Catalyst AC-11 product and after prolonged use of the topical product regimen
Claim Support
Reduces capillary redness and capillary visibility
Expert Clinical Grading SIAScope Subjective Questionnaires Photo Documentation (n=5)
Improves skin elasticity and firmness
Expert Clinical Grading (elasticity only) Subjective Questionnaires Cutometer
Improves eyelid laxity Expert Clinical Grading Subjective Questionnaires Photo Documentation (n=5)
Improves the appearance of lines/wrinkles
Improves skins overall appearance, radiance and luminosity
Study Products
Name Formula Number
Purify OS-PRD-PUR-200
Catalyst AC - 11 OS-PRD-CAC-030
Spritz Clear Plus OS-PRD-CLR-100
Quench Plus OS-PRD-QUE-031
Supportive Products Dove Beauty Bar, White Purpose Dual Treatment Moisture Lotion with SPF 15
NA NA
Statistical Methodology
Descriptive statistics reported for demographics, instrumental and visual assessments. Monadic data analyses will use paired t-test to determine significance of change from Baseline. Questionnaire response frequencies and mean indicated percent improvement reported for each question. All final statistical analyses will be performed on the PP population, significance set at p≤0.05.
Study Schedule Initiation: Consent / Washout June 8, 2015
Baseline June 15, 2015
Week 1 June 22, 2015
Week 4 July 13, 2015
Completion: Week 8 August 10, 2015
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Summary This was an eight-week, monadic evaluation of the immediate effects of one test product on the condition and appearance of facial skin and of the long-term effects of a test product regimen on the condition and appearance of facial skin. A study panel of 33 subjects was enrolled in the study and completed participation.
Under the conditions of this study, under the conditions of this study, use of Catalyst AC–11 #OS-PRD-CAC-030 alone and of a regimen consisting of Purify #OS-PRD-PUR-200; Catalyst AC–11 #OS-PRD-CAC-030; Spritz Clear Plus #OS-PRD-CLR-100; Quench Plus #OS-PRD-QUE-031 led to significant improvements in skin appearance and condition as evidenced by results from expert clinical grading, instrumental assessments and subjective questionnaire results. See Section 20.0 Conclusion for further detail.
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Table of Contents
1.0 Introduction ............................................................................................................................................ 7
2.0 Objectives................................................................................................................................................ 7
3.0 Study Design ............................................................................................................................................ 7
4.0 Product .................................................................................................................................................... 8
5.0 Population ............................................................................................................................................... 9
6.0 Methods ................................................................................................................................................ 11
7.0 Procedure .............................................................................................................................................. 14
8.0 Concomitant Medications and Products .............................................................................................. 16
9.0 Adverse Events ...................................................................................................................................... 17
10.0 Institutional Review Board .................................................................................................................. 17
11.0 Informed Consent ............................................................................................................................... 17
12.0 Discontinuation of Study ..................................................................................................................... 17
13.0 Changes to the Protocol ...................................................................................................................... 17
14.0 Monitoring .......................................................................................................................................... 18
15.0 Recording of Data ............................................................................................................................... 18
16.0 Quality Control and Quality Assurance ............................................................................................... 18
17.0 Ethics ................................................................................................................................................... 18
18.0 Statistical Methods ............................................................................................................................. 18
19.0 Results ................................................................................................................................................. 20
20.0 Conclusion ........................................................................................................................................... 29
Appendices Appendix I Protocol Appendix II Protocol Deviations Appendix III Adverse Events Appendix IV Data Listing and Statistical Report
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List of Abbreviations
AE BL C cm CRF CFR D FDA GCP HIPAA ICF ICH IND IRB IRSI AIDS n NDA PI PP SAE SOP T15m TEWL US VAS
Adverse Event Baseline Collect Centimeter Case Report Form Code of Federal Regulations Dispense Food & Drug Administration Good Clinical Practices Health Insurance Portability and Accountability Act Informed Consent Form International Conference on Harmonization Investigational New Drug Institutional Review Board International Research Services, Inc. Acquired Immunodeficiency Syndrome Number of Subjects New Drug Application Principal Investigator Per-Protocol Serious Adverse Event Standard Operating Procedure 15 minutes post initial product application Trans-Epidermal Water Loss United States Visual Analogue Scale
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1.0 Introduction
This document is a report for a human research study. This study was conducted according to International Research Services, Inc. research policies and Standard Operating Procedures, U.S. and international standards of Good Clinical Practice (FDA and ICH guidelines) and applicable government regulations.
2.0 Objectives
2.1 Primary Objective
The efficacy of a topical product regimen, including four products intended to improve facial skin appearance and condition, was evaluated by this study.
2.2 Secondary Objective
The immediate efficacy of one topical product intended to improve facial skin appearance and condition was evaluated by this study.
3.0 Study Design
This was an eight-week monadic clinical study to evaluate an individual product’s immediate effects and a topical product regimen’s effects after one, four and eight weeks of use. Data were analyzed for signs of improvement in facial skin condition and appearance in female subjects who have photodamaged skin. Assessments included expert clinical visual grading, instrumental assessments and photographic documentation. Subjects’ perception of product effects was captured via subjective questionnaire. The treatment products were used daily per Sponsor instructions by all subjects for eight weeks. Thirty-three (33) subjects completed study participation. The study was preceded by a one-week washout period, within which subjects discontinued use of all facial cleansers and moisturizers and used only support product on their faces, as directed by IRSI.
Study visits occurred at Screening/ Washout (T-7D), Baseline (BL), Immediate (T15m) and at Weeks 1, 4 and 8 (W1, W4 and W8). A detailed outline of study visits appears in Section 7.0 of the protocol (Appendix I).
3.1 Claims:
Assessment and questionnaire data were analyzed with particular regard to the following desired key product effects for the regimen of four products after prolonged use:
1. Reduces capillary redness and capillary visibility, as determined by expert clinical grading, SIAScope, subjective questionnaires and photo documentation.
2. Improves elasticity and firmness, as determined by expert clinical grading (elasticity only), Cutometer and subjective questionnaires.
3. Improves eyelid laxity, as determined by expert clinical grading, subjective questionnaires and photo documentation.
4. Improves the appearance of lines/wrinkles, as determined by expert clinical grading, subjective questionnaires and photo documentation.
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5. Improves skins overall appearance, radiance and luminosity, as determined by expert clinical grading, subjective questionnaires and photo documentation.
3.2 Claims (Catalyst AC-11)
Assessment and questionnaire data were analyzed with particular regard to the following desired key product effects for the Catalyst AC-11 cream after a single application:
1. Immediately reduces capillary redness and capillary visibility, as determined by expert clinical grading, subjective questionnaires and photo documentation.
2. Immediately improves eyelid laxity, as determined by expert clinical grading, subjective questionnaires and photo documentation.
3. Immediately improves elasticity and firmness, as determined by expert clinical grading (elasticity only), Cutometer and subjective questionnaires (elasticity only).
4. Immediately improves the appearance of lines/wrinkles, as determined by expert clinical grading, subjective questionnaires and photo documentation.
5. Immediately improves skins overall appearance, radiance and luminosity, as determined by expert clinical grading, subjective questionnaires and photo documentation.
4.0 Product
All products were provided by the Sponsor and were labeled with appropriate codes and proper use instructions. Supportive product(s) were provided by IRSI. Upon receipt, product was logged in and stored in a secure area. Within one month of issuance of the final signed report, unless otherwise instructed in writing, all test products, used and unused, will be destroyed and disposed of in accordance with IRSI’s SOP. Product Descriptions
Name Designation Formula Number Quantity Received
Date Received
Study Product
Purify Cleanser OS-PRD-PUR-200 45 06-04-15
Catalyst AC-11 Gel OS-PRD-CAC-030 85 06-04-15
Spritz Clear Plus Enhancer OS-PRD-CLR-100 45 06-04-15
Quench Plus Moisturizer OS-PRD-QUE-031 85 06-04-15
Supportive Products
Dove Beauty Bar, White Washout Cleanser
NA
Purpose Dual Treatment Moisture Lotion with SPF 15
SPF Moisturizer
NA
4.2 Product Use Instructions
Subjects were provided with Support Washout Cleanser and SPF Moisturizer approximately seven days before Baseline.
At Baseline, subjects discontinued use of the Support Washout Cleanser and SPF Moisturizer and were provided with the test product regimen to use for the duration of the study.
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At the Baseline visit, all subjects applied the Catalyst AC-11 product only to the face following Sponsor instructions under IRSI technician supervision. Sponsor-provided use instructions were explained to subjects and were provided to each subject in their printed Study Instructions (See Appendix I Protocol, Appendix I).
Test Product Directions:
Use the test products twice daily, morning and evening in the following sequence:
Step 1: Wash face with Purify:
Apply ½ pump into palm of hand and lather face and neck with warm water, thoroughly Cleanse and rinse until all product has been removed. Dry skin with a soft towel.
Step 2: Apply Catalyst AC-11
Apply two pumps into hand and massage onto face and neck thoroughly. Massage into skin thoroughly.
Step 3: Spritz Clear Plus:
Spray Clear Plus 3-5 times onto face and neck and massage skin again until all product is absorbed into skin. This step is essential to ensure Catalyst AC-11 is fully absorbed.
Step 4: Quench Plus:
Apply 1-2 pumps Quench Plus into hand and massage onto entire face and neck. Support Product Directions:
Washout Period (T-7d):
Washout Cleanser: Use daily in place of your normal facial cleanser.
SPF Moisturizer: Apply daily in the morning prior to sun exposure, reapply every 2 hours as needed throughout the day during sun exposure during the washout period.
Study Period: Per sponsor, no sunscreen is permitted for use during study period.
Avoid sun exposure to the face, no sunscreen use is permitted, use hats and/or umbrellas when going into sun.
5.0 Population
5.1 Sample Size
The sample size of n=30 was requested by the Sponsor. A total number of 33 subjects were enrolled in the study and completed participation.
5.2 Inclusion Criteria
1. Females, in good general health, and between the ages of 35 and 59 years old, inclusive, at time of enrollment.
2. Subjects with lines and wrinkles and eyelid laxity as determined by an expert grader at Baseline.
a. Score of ≥2 cm on 10 cm VAS for fine lines/wrinkles (crow’s feet)
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b. Score of ≥2 cm on 10 cm VAS for eyelid laxity 3. A portion of the panel (approximately n=10) with Capillary visibility (telangiectasia)
a. Score of ≥2 cm on 10 cm VAS for capillary visibility 4. A portion of the panel (approximately n=10) with actinic keratosis as determined by an
expert grader at baseline. a. Score of ≥2 cm on 10 cm VAS for actinic keratosis severity
5. Willing to be photographed and sign a photograph release form. 6. Able to read, understand and willing to sign an ICF, including HIPAA and state requirements,
complete a brief personal/medical history 7. Dependable and willing to attend study visits and comply with all study instructions and
requirements, including but not limited to: a. Willing to abstain from any other superficial or deep facial procedure during the
study (dermabrasion, microdermabrasion, peels, photo facials, laser treatment, facial lesion removal, etc.).
b. Willing to abstain from use of all other topical products for the duration of the washout period and study period.
c. Willing to abstain from the use of tanning bed use and recreational sun exposure on the face for the duration of the washout period and study period.
5.3 Exclusion Criteria
1. Subjects using systemic or topical steroids, Accutane, oral or topical estrogens, and/or other
medicines affecting skin in a major way during study period or washout period.
2. Subjects with present or previous inflammatory or other skin diseases, such as rosacea,
severe acne, Systemic Lupus Erythematosus (SLE), dermatomyositis, scleroderma, etc.
3. Current or Smokers within one month prior to enrollment
General exclusion criteria:
4. Subjects participating in any other clinical studies
5. Subjects having an acute or chronic disease or medical condition, including dermatological
problems, which could put her at risk in the opinion of the Principal Investigator or
compromise study outcomes. Typical uncontrolled chronic or serious diseases and
conditions which would prevent participation in any clinical trial are cancer, AIDS, diabetes,
morbid obesity, renal impairment, mental illness, drug/alcohol addiction.
6. Subjects who are unreliable or unlikely to be available for the duration of the study
7. History of allergic reactions, skin sensitization and/or known allergies to cosmetic
ingredients, toiletries, sunscreens, etc.
8. Immunocompromised subjects
9. Woman who started Hormone Replacement Therapy within the last three months preceding
the screening visit
10. Woman using oral contraception for less than three months before the screening visit or who
has changed her contraceptive method within the three months before the Baseline visit or
planning to modify her contraception treatment within the duration of the study
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11. Woman known to be pregnant, lactating or planning to become pregnant within six months.
Subjects who become pregnant during the study must inform the Principal Investigator
immediately
12. Individuals unable to communicate or cooperate with the Principal Investigator due to
language problems, poor mental development, or impaired cerebral function
13. Employees of IRSI or other testing firms/ laboratories, cosmetic or raw goods manufacturers
or suppliers
6.0 Methods
This study was performed in accordance to IRSI final signed clinical study protocol number 3931OSM0415 version 2.6 dated June 29, 2015 and outlined below.
6.1 Expert Grading Assessments for Efficacy
Visual Analog Scales (VAS) are commonly used in clinical research to measure intensity or frequency of various symptoms, subjective characteristics or attitudes that cannot be directly measured. VAS are a reliable scale and more sensitive to small changes than simple ordinal scales. When responding to a VAS item, the expert grader specifies their level of agreement to a statement by indicating a position along a line (10 cm) between two end-points or anchor responses. Simple VAS was used to evaluate efficacy parameters in which the ends of a 10 cm horizontal line were defined as extreme limits orientated from the left (best) to the right (worst).
All subjects had facial skin texture /smoothness (visual), lines/wrinkles (crow’s feet), elasticity (tactile), eyelid laxity, radiance/luminosity, and overall appearance assessed by an expert grader at BL, T15m, W1, W4 and W8. A portion of the panel which presented with capillary visibility and Actinic Keratosis at Baseline were assessed by an expert grader for these attributes at BL, T15m, W1, W4 and W8, with n=19 presenting with Capillary Visibility and n=14 presenting with Actinic Keratosis.
The same expert grader assessed the same subjects at every time point. Clinical grading was performed in the same room at each study visit using overhead lighting as well as a lighted magnifying loop as needed. Natural sunlight was blocked from the room to ensure the same lighting conditions at each time point.
The following IRSI-developed VAS were used:
Texture / Smoothness - Visual
0 cm 10 cm Smooth, even
surface appearance
Rough, uneven surface
appearance
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Fine Lines/Wrinkles (Crow’s Feet)
0 cm 10 cm
None
Numerous lines/ Wrinkles –
Severe, Deep
Radiance / Luminosity
0 cm 10 cm Radiant,
Luminous appearance
Dull/Matte
and/or Sallow
Eyelid Laxity
0 cm 10 cm Taut,
“awake”, smooth eyelid
Sagging, “tired”,
drooping eyelid
Elasticity (tactile)
0 cm 10 cm Good
Stretch and Bounce back
Poor Stretch and Bounce
back
Overall Appearance
0 cm 10 cm Vibrant, Healthy
appearance
Aged, Unhealthy
appearance
Capillary Visibility*
0 cm 10 cm
None *Only graded on n=19 subjects which presented this at Baseline
(portion of panel)
Highly visible,
intense red capillary
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Actinic Keratosis Severity*
0 cm 10 cm
None *Only graded on n=14 subjects which presented this at Baseline
(portion of panel)
Highly visible patches
6.2 Instrumental Evaluations
Test environment temperature (°F) and humidity (%) was recorded in every room used for study conduct every hour. Additionally, once-daily outdoor conditions were recorded for each visit, this data is filed in the on-site study file and available to the sponsor upon request.
6.2.1 COSMETRICS™ SIAscope
The COSMETRICS™ SIAScope (Astron Clinica, Toft, UK) is a non-invasive optical skin imaging instrument using Spectrophotometric Intracutaneous Analysis (SIA), or chromophore mapping. The technique is based on a unique combination of dermatoscopy and contact remittance spectrophotometry. The hardware consists of a hand-held imaging probe attached to a laptop computer. The unit is placed in contact with the skin surface and high-intensity LED’s illuminate the skin as discreet wavelengths of 400 to 1000nm, spanning the visible spectrum and a small range of the near infrared spectrum. A digital image is captured for each wavelength.
Three parametric chromophore maps are retrieved up to 2 mm in depth and 11 mm in circumference, one for each of the following parameters: epidermal melanin, dermal hemoglobin and dermal collagen.
For this study, dermal hemoglobin measurements were taken in duplicate and averaged on a spot determined at Baseline with visible red capillaries if applicable or on the cheek if no capillaries visible, at BL, W1, W4 and W8. The same location was measured at each time point and recorded using a face map.
6.2.2 CUTOMETER
The Cutometer MPA 580 (Courage + Khazaka, Germany) measures the viscoelastic properties of the skin by applying suction to the skin surface, drawing the skin into the aperture of the probe and determining the penetration depth using an optical measuring system.
The resistance of the skin to be sucked up by the negative pressure (firmness) and its ability to return to its original position (elasticity) are calculated and displayed as curves. The Cutometer outputs include many parameters of different portions of the measurement curve including of R0 (Uf, firmness), R2 (Ua/Uf, gross elasticity), R5 (Ur/Ue, net elasticity), R7 (Ur/Uf, elastic portion) and R9 (R3[last max amp]-R0[Uf], fatigue).
Skin Elasticity is reported using the R5 (Ur/Ue) parameter, as the skin becomes more elastic this value will increase. Skin Firmness is reported using the R0 (Uf) parameter, as the skin becomes firmer this value will decrease.
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All subjects had Cutometer measurements taken on their left or right cheek, as determined by a randomization code, in duplicate and averaged at BL, T15m, W1, W4 and W8. Assessment location was recorded on a face map for each subject.
6.3 Photography
All clinical photography was performed in accordance with IRSI’s SOP to ensure reproducibility of high quality images throughout the duration of the study. Imaging was conducted in a designated photography suite with a matte black wall and all natural light is blocked out. To prepare subjects for clinical photography, subjects were asked to remove all jewelry, including earrings, necklaces and any facial jewelry. A trained technician inspected the subjects under a lighted magnification loop to ensure no residual color cosmetics or skincare products were visible on the face, eyes or lips. Subjects were provided with a black cape and black headband and instructed on placement to ensure all hair is pulled back neatly and covered.
6.3.1 Clarity™ 2D Research System Ti
The Clarity™ 2D Research System Ti (Clarity) (BrighTex Bio-Photonics (BTBP), San Jose CA, USA) captures high quality full face frontal, left and right lateral images. Three cameras within the system allow for 18 megapixel SLR image capture in 16-bit simultaneously using a live feed display and automated facial alignment checks against baseline images for reproducibility.
A subgroup of five (N=5) subjects chosen at random had Left, Right and Center facial images captured at BL, W1, W4 and W8. Photographs are for documentation purposes only.
6.4 Subjective Questionnaire
Subjective questionnaires allow the Sponsor to gauge the subjects’ opinions of the test product and its effects. Questions asked for subjects’ agreement to a statement with a five point scale, IRSI provided questionnaire and performed analysis (See Appendix I Protocol, Appendix II).
Subjects completed the questionnaire at T15m regarding Catalyst AC-11 immediate effects and again at W1, W4 and W8 regarding prolonged use of the four product regimen.
7.0 Procedure
7.1 Consent / Screening Visit / Washout
Potential subjects came to the clinic approximately seven days prior to the Baseline visit to read and sign an informed consent form (ICF), as described in Section 11, a model release form, inclusion / exclusion criteria and to complete a brief personal/medical history.
Unless a response(s) on their medical history form, inclusion / exclusion criteria or ICF indicate that they are not qualified to participate in the study, each potential subject received the support Washout Cleanser and Washout SPF Moisturizer and instructions for its use during the seven-day washout period.
They then received an appointment time for their Baseline visit and were dismissed from the consent / screening / washout visit.
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7.2 Baseline Visit
Subjects arrived at IRSI with clean facial skin, having washed their face and applied no topical treatment or cosmetic products within one hour prior to their visit.
Potential subjects acclimated to clinic environment with their facial skin exposed for at least 15 minutes allowing subject to relax and let their skin balance to the environment.
Following acclimatization, potential subjects were screened to determine if they meet study entrance criteria as described in Section 5.2 and 5.3.
The following Screening procedures were performed and all findings reported on the appropriate CRFs:
- Review of compliance to washout, updated Medical History and inclusion / exclusion criteria.
- Expert visual evaluation for any skin condition which would disqualify subject from study enrollment.
- Expert visual evaluation for qualification according to inclusion criteria 4.a and 4.b, above, in section 5.2.
Subjects who met entrance criteria as defined in Section 5.2 and 5.3 were enrolled and proceeded with study participation.
The following BL assessments were performed and all findings reported on the appropriate CRFs:
- Expert visual grading as described in Section 6.1 - Instrumental assessments as described in Section 6.2 - Photography as described in Section 6.3
All subjects were provided with the test product regimen along with instructions and diary to record use per section 4.2.
Subjects applied the Catalyst AC-11 product to their face under supervision as described in Section 4.2.
Approximately 15 minutes post-application the following T15m assessments began and all findings were reported on the appropriate CRFs:
- Expert visual grading as described in Section 6.1 - Instrumental assessments as described in Section 6.2 - Subjective Questionnaire as described in Section 6.4
Subjects were advised to inform the laboratory immediately if any adverse reactions were experienced during the study.
After all evaluations are completed, subjects were given an appointment time for their Week 1 visit and dismissed from the Baseline visit.
7.3 Week 1, 4 and Week 8 Visits
Subjects arrived at IRSI with clean facial skin, having washed their face and applied no topical treatment or cosmetic products within one hour prior to their visit.
Review of compliance to study instructions, updated Medical History Subjects acclimated to clinic environment with their facial skin exposed for at least 15 minutes
allowing subject to relax and let their skin balance to the environment. The following assessments were performed and all findings reported on the appropriate CRFs:
- Expert visual grading as described in Section 6.1 - Instrumental assessments as described in Section 6.2 - Photography as described in Section 6.3
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- Subjective Questionnaires as described in Section 6.4 Each subject’s products were inspected to ensure product use compliance and/or that enough
product remains for study duration, and diaries were reviewed and/or subjects queried to detect any changes in subject’s health.
At W1 and W4, subjects were advised to inform the laboratory immediately if any adverse reactions were experienced during the study.
At W1 and W4, after all evaluations are completed, subjects were given an appointment time for their next visit and dismissed.
At W8, subjects were advised to inform the laboratory immediately if any adverse reactions were experienced during the 48 hours following study completion.
At W8, after all evaluations are completed, subjects returned any unused products and/or empty containers and were given a stipend for their participation and dismissed from the study.
7.3.1 Procedure Summary Table
Procedures Screening/ Washout Baseline
Immediate Week 1 Week 4 Week 8
Study Initiation and Qualification
Informed Consent and Medical History
X
Inclusion/Exclusion Criteria reviewed
X X
Dispense/ Collect Products D
Support D
Test
C
Expert Clinical Grading
- Texture (visual) -Lines/Wrinkles (Crow’s Feet) - Radiance/ Luminosity -Eyelid Laxity -Elasticity -Overall Appearance -Capillary Visibility - Actinic Keratosis Severity
X X X X X
Instrumental Evaluation
SIAScope (hemoglobin)
X
X X X
Cutometer (elasticity,
firmness) X
X X X X
Photography Clarity 2DResearch Ti (n=5, L, R,C views)
X
X X X
Consumer Perception
Subjective Questionnaire
X
Catalyst AC-11 only
X X X
8.0 Concomitant Medications and Products
The use of any topical skin treatment products (other than those assigned during the study) on the face was prohibited during the washout and study periods. This included, but was not limited to moisturizers, serums, cleansers, sunscreens and medicated creams.
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Use of superficial or deep facial procedures during the study was prohibited including dermabrasion, microdermabrasion, peels, photo facials, laser treatments, facial lesion removal.
Major medical procedures were prohibited including endoscopy or any procedure requiring sedation.
The use of color cosmetics was allowed, but introduction of new personal care products was prohibited for the duration of the study.
Smoking was prohibited for the duration of the study.
9.0 Adverse Events
One adverse event was reported during the conduct of this study.
1. Subject #33 reported on July 14, 2015 that she had experienced severe nephrolithiasis on July 13, 2015 which necessitated a visit to hospital emergency room. Kidney stones were passed by subject during emergency room visit and subsequent urinalysis results were within normal ranges. Subject was discharged from the hospital emergency room with no follow-up required and no medications prescribed. The event had no relationship to the study product and no further follow-up from clinic staff was deemed necessary.
10.0 Institutional Review Board
IRB review and approval of this study was not requested by the Sponsor.
11.0 Informed Consent
The informed consent process was completed prior to an individual’s involvement in any study related activity. The process was documented using a written informed consent form (ICF) conforming to FDA 21 CFR 50.25 (See Appendix I Protocol, Section 11.0 and Appendix IV).
After review, two copies of the ICF were signed and dated by the individual and the Principal Investigator or his designee administering the consent. One original copy was retained by IRSI and the other was given to the individual.
12.0 Discontinuation of Study
The study was completed on schedule as per the clinical study protocol (and subsequent amendments).
13.0 Changes to the Protocol
13.1 Protocol Amendments
No amendments were made to the final signed protocol for this study.
13.2 Protocol Deviations
Two protocol deviations occurred during the study. See Appendix II for signed protocol deviation form.
1. Minor: Subject # 24 was enrolled at age 60 years, contrary to the protocol, Section 5.2, Inclusion Criteria, number one.
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2. Minor: Subject # 02 did not respond to Question # 13 of the Week 4 Questionnaires as required per protocol.
14.0 Monitoring
The Sponsor did not monitor any portion of this clinical study.
15.0 Recording of Data
All data and information, except electronically recorded data, was recorded on specific paper case report forms (CRFs) as described in the clinical study protocol (See Appendix I Protocol, Appendix III).
16.0 Quality Control and Quality Assurance
This clinical study has been audited by the IRSI Quality Assurance / Quality Control auditor. The auditor verified study for accuracy, consistency and proper documentation in accordance to IRSI SOPs and practices. Additionally, accuracy of results reported in the body of this report with respect to the results reported in the data listings and statistical report (See Appendix II). The data listings and database used for statistical analysis was verified against the CRFs. The data listings were verified against the CRFs for 100% of the data, in a randomly selected set of the subjects (25% of the total number of subjects). The statistical report was validated for accuracy and completeness, as well as verifying the correctness of all subject numbers (n) and the analyses performed according to the Statistical Analysis Plan as described in Section 18 of the clinical study protocol.
17.0 Ethics
The study was conducted in accordance with FDA GCP regulations and ICH guidelines in as much as they apply to cosmetic research with the following noted: This was not an IND / NDA clinical trial. IRSI does not assume any Sponsor obligations as stipulated in FDA GCP and ICH documents. This study is not intended for submission to the FDA.
18.0 Statistical Methods
The planned statistical analysis was performed as outlined in the study protocol for each type of data to be acquired. (See Protocol, Section 18.0)
The per-protocol (PP) population is defined as the subset of subjects that who complied with the protocol sufficiently to ensure that their data will be likely to exhibit the effects of the treatment. To be considered a PP subject, a subject could not miss more than one study visit (excluding Baseline or Week 8) or be found to be non-compliant with the study protocol at the discretion of the Principal Investigator (PI).
The PP population was used for statistical analysis at each time point. Statistical significance was set at p≤0.05.
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Data Type Statistical Method Data Reported
Demographics Descriptive Statistics Mean and standard deviation Min and Max Frequency (number and percent)
Clinical Grading for Efficacy, Instrumental Evaluation
Descriptive Statistics Paired T-test (monadic),
Mean and standard deviation Mean percent improvement from Baseline Percent of subjects improving P-value vs. Baseline
Subjective Questionnaire Descriptive Statistics
Frequency tables (n and %) of each response Percent of subjects responding favorably.
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19.0 Results
19.1 Tables
Enrollment and demographic information is reported below in Tables 1.0-2.0. Expert clinical grading results are included in Table 3.0, instrumental results are included in Table 4.0 and subjective questionnaire results are included in Table 5.0.
Table 1.0 Enrollment Status n
Enrolled 33
Discontinued 0
Completed Baseline time point 33
Completed Week 1 time point 33
Completed Week 4 time point 32 Subject #33 missed the Week 4 visit.
Completed Week 8 time point 33
Table 2.0 Demographics
*See Protocol Deviation #1
Variable n Mean ± SD Min Max
Age (years) 33 51.51 ± 6.80 35 60*
Height (inches) 33 64.18 ± 2.76 59 69
Weight (pounds) 33 166.90 ± 42.91 96 300
n Percent
Ethnicity 33 Hispanic or Latino 6 18.2%
Not Hispanic or Latino 27 81.8%
n Percent
Race 33
African American or Black 1 3.0%
White 27 81.8%
No Response (see Hispanic or Latino above)
5 15.2%
n Percent
Fitzpatrick Skin Type 33
Skin Type I 1 3.0%
Skin Type II 10 30.3%
Skin Type III 15 45.5%
Skin Type IV 6 18.2%
Skin Type V 1 3.0%
n Percent
Facial Skin Type 33
Combination 15 45.5%
Dry 3 9.1%
Normal 14 42.4%
Oily 1 3.0%
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Table 3.0 Experts Clinical Grader Evaluation – Catalyst AC-11 – Monadic, Comparison to Baseline
Assessment Time Point n Mean ± SD Mean Percent Improvement From BL mean
Percent of Subjects Showing
Improvement From BL
P-Value TX vs. BL
Texture/Smoothness (visual)
Baseline 33 4.05 ± 0.49
Immediate 33 3.07 ± 0.55 23.66% 97.0% <0.001*
Fine Lines/Wrinkles (Crow’s Feet)
Baseline 33 4.20 ± 0.86
Immediate 33 3.71 ± 0.77 11.47% 100% <0.001*
Radiance/Luminosity Baseline 33 4.73 ± 0.42
Immediate 33 3.20 ± 0.59 31.52% 93.9% <0.001*
Eyelid Laxity Baseline 33 3.86 ± 0.90
Immediate 33 3.66 ± 0.85 4.59% 72.7% 0.001*
Elasticity (tactile) Baseline 33 3.90 ± 0.36
Immediate 33 3.46 ± 0.35 10.98% 93.9% <0.001*
Overall Appearance Baseline 33 4.80 ± 4.25
Immediate 33 4.25 ± 0.57 11.48% 84.8% <0.001*
Capillary Visibility Baseline 19^ 4.38 ± 0.68
Immediate 19^ 4.14 ± 0.71 5.56% 78.9% 0.001*
Actinic Keratosis Severity
Baseline 14^ 3.59 ± 0.66
Immediate 14^ 3.28 ± 0.58 8.37% 86.7% <0.001* ^Only subjects who present Capillary Visibility and Actinic Keratosis Severity at Baseline were assessed for all visits. NI=No Improvement *Indicates a statistically significant improvement compared to baseline, p≤0.05 **Indicates a statistically significant worsening compared to baseline, p≤0.05
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Table 3.1 Experts Clinical Grader Evaluation – Regimen – Monadic, Comparison to Baseline
Assessment Time Point n Mean ± SD Mean Percent Improvement From BL mean
Percent of Subjects Showing
Improvement From BL
P-Value TX vs. BL
Texture/Smoothness (visual)
Baseline 33 4.05 ± 0.49
Week 1 33 4.27 ± 0.44 NI 42.4% 0.069
Week 4 32 4.12 ± 0.27 NI 59.4% 0.577
Week 8 33 3.59 ± 0.49 10.13% 75.8% <0.001*
Fine Lines/Wrinkles (Crow’s Feet)
Baseline 33 4.20 ± 0.86
Week 1 33 4.66 ± 0.98 NI 18.2% 0.002**
Week 4 32 4.00 ± 0.82 3.80% 62.5% 0.072
Week 8 33 3.48 ± 0.78 16.67% 87.9% <0.001*
Radiance/Luminosity
Baseline 33 4.73 ± 0.42
Week 1 33 4.66 ± 0.57 1.28% 57.6% 0.420
Week 4 32 4.20 ± 0.38 10.84% 84.4% <0.001*
Week 8 33 3.20 ± 0.72 32.00% 100% <0.001*
Eyelid Laxity
Baseline 33 3.86 ± 0.90
Week 1 33 3.78 ± 0.79 NI 51.5% 0.559
Week 4 32 3.50 ± 0.59 5.52% 59.4% 0.009*
Week 8 33 3.23 ± 0.61 14.08% 81.8% <0.001*
Elasticity (tactile)
Baseline 33 3.90 ± 0.36
Week 1 33 3.89 ± 0.37 NI 39.4% 0.862
Week 4 32 3.97 ± 0.27 NI 31.3% 0.153
Week 8 33 3.50 ± 0.35 9.80% 75.8% <0.001*
Overall Appearance
Baseline 33 4.80 ± 4.25
Week 1 33 4.61 ± 0.35 3.63% 69.7% 0.008*
Week 4 32 4.33 ± 0.35 8.89% 84.4% <0.001*
Week 8 33 3.80 ± 0.51 20.91% 100% <0.001*
Capillary Visibility
Baseline 19^ 4.38 ± 0.68
Week 1 19^ 4.37 ± 0.65 NI 42.1% 0.907
Week 4 18^ 3.92 ± 0.57 11.29% 88.9% <0.001*
Week 8 19^ 3.26 ± 0.61 25.19% 89.5% <0.001*
Actinic Keratosis Severity
Baseline 14 3.59 ± 0.66
Week 1 14^ 3.80 ± 0.66 NI 35.7% 0.284
Week 4 13^ 3.34 ± 0.42 3.29% 53.8% 0.251
Week 8 14^ 2.95 ± 0.52 15.49% 92.9% 0.005* ^Only subjects who present Capillary Visibility and Actinic Keratosis Severity at Baseline were assessed for all visits. NI=No Improvement *Indicates a statistically significant improvement compared to baseline, p≤0.05 **Indicates a statistically significant worsening compared to baseline, p≤0.05
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Table 4.0 Instrumental Evaluation - Catalyst AC-11 – Monadic, Comparison to Baseline
Assessment Time Point n Mean ± SD
Mean Percent
Improvement From BL
mean
Percent of Subjects Showing
Improvement From BL
P-Value TX vs. BL
Cutometer
Firmness (R0 Uf)
Baseline 33 0.23 ± 0.05
Immediate 33 0.24 ± 0.05 NI 45.5% 0.335
Elasticity (R5 Ur/Ue)
Baseline 33 0.39 ± 0.14
Immediate 33 0.40 ± 0.17 2.99% 51.5% 0.787 NI= No improvement *Indicates a statistically significant improvement compared to baseline, p≤0.05 **Indicates a statistically significant worsening compared to baseline, p≤0.05
Table 4.1 Instrumental Evaluation – Regimen – Monadic, Comparison to Baseline
Assessment Time Point n Mean ± SD
Mean Percent
Improvement From BL
mean
Percent of Subjects Showing
Improvement From BL
P-Value TX vs. BL
Cutometer
Firmness (R0 Uf)
Baseline 33 0.23 ± 0.05
Week 1 33 0.24 ± 0.04 NI 33.3% 0.232
Week 4 32 0.22 ± 0.04 1.13% 59.4% 0.227
Week 8 33 0.21 ± 0.04 5.59% 63.6% 0.008*
Elasticity (R5 Ur/Ue)
Baseline 33 0.39 ± 0.14
Week 1 33 0.38 ± 0.07 11.32% 51.5% 0.823
Week 4 32 0.52 ± 0.10 45.00% 84.4% <0.001*
Week 8 33 0.72 ± 0.11 109.85% 97.0% <0.001*
SIAScope Hemoglobin
Baseline 33 470.98 ± 45.00
Week 1 33 569.70 ± 73.71 NI 3.0% <0.001**
Week 4 32 169.20 ± 23.73 63.56% 100% <0.001*
Week 8 33 166.19 ± 29.32 64.25% 100% <0.001* NI= No improvement *Indicates a statistically significant improvement compared to baseline, p≤0.05 **Indicates a statistically significant worsening compared to baseline, p≤0.05
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Table 5.0 Subjective Questionnaire - Catalyst AC-11– Consumer Perception
Question n
Immediate Percent
Responding Favorably
Response n (%) Strongly
Agree Agree Neutral Disagree
Strongly Disagree
1. The product immediately reduced the capillary redness of my facial skin.
33 1 (3.0%) 5 (15.2%) 24 (72.7%) 1 (3.0%) 2 (6.1%) 18.2%
2. The product immediately improved the laxity (droopiness) of my eyelid.
33 1 (3.0%) 8 (24.2%) 21 (63.6%) 1 (3.0%) 2 (6.1%) 27.3%
3. The product immediately improved the firmness of my facial skin.
33 4 (12.1%) 13 (39.4%) 14 (42.4%) 1 (3.0%) 1 (3.0%) 51.5%
4. The product immediately improved the elasticity of my facial skin.
33 4 (12.1%) 16 (48.5%) 11 (33.3%) 1 (3.0%) 1 (3.0%) 60.6%
5. The product immediately lifted my facial skin and improved the appearance of sagging in my face.
33 3 (9.1%) 12 (36.4%) 16 (48.5%) 1 (3.0%) 1 (3.0%) 45.5%
6. The product immediately tightened my facial skin.
33 3 (9.1%) 19 (57.6%) 9 (27.3%) 1 (3.0%) 1 (3.0%) 66.7%
7. The product immediately improved the appearance of lines/ wrinkles on my crow’s feet area.
33 2 (6.1%) 4 (12.1%) 24 (72.7%) 1 (3.0%) 2 (6.1%) 18.2%
8. The product immediately improved the appearance of lines/ wrinkles on my facial skin.
33 1 (3.0%) 4 (12.1%) 25 (75.8%) 1 (3.0%) 2 (6.1%) 15.2%
9. My facial skin appears less dull and more radiant immediately after using the product.
33 1 (3.0%) 16 (48.5%) 13 (39.4%) 2 (6.1%) 1 (3.0%) 51.5%
10. The product immediately improved the appearance of my facial skin, illuminating my complexion with a fresh youth infused glow.
33 2 (6.1%) 12 (36.4%) 16 (48.5%) 2 (6.1%) 1 (3.0%) 42.4%
11. The product immediately enhanced the overall appearance of my facial skin.
33 2 (6.1%) 13 (39.4%) 15 (45.5%) 2 (6.1) 1 (3.0%) 45.5%
12. I did not experience any irritation after product application.
33 13 (39.4%) 11 (33.3%) 7 (21.2%) 1 (3.0%) 1 (3.0%) 72.7%
Question n Response n (%) Percent
Responding Favorably
Strongly Agree
Agree Neutral Disagree Strongly Disagree
N/A
13. I immediately felt there was a relief in my actinic keratosis (scaly, crusty lesion).
14* 1
(6.7%) 3
(20%) 9
(60%) 2
(13.3%) 0
(0.0%) 19 21.4%
Bold/ Shaded = the majority of subjects responded favorably, >50% *Only subjects included in the Actinic Keratosis group (n=14) were included in the analysis.
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Table 5.0 Subjective Questionnaire – Regimen – Consumer Perception (Continued)
Question n
Week 1 Percent
Responding Favorably
Response n (%) Strongly
Agree Agree Neutral Disagree
Strongly Disagree
1. The product reduced the capillary redness of my facial skin.
33 2 (6.1%) 11 (33.3%) 16 (48.5%) 3 (9.1%) 1 (3.0%) 39.4%
2. The product improved the laxity (droopiness) of my eyelid.
33 0 (0.0%) 12 (36.4%) 18 (54.5%) 2 (6.1%) 1 (3.0%) 36.4%
3. The product improved the firmness of my facial skin.
33 3 (9.1%) 20 (60.6%) 9 (27.3%) 0 (0.0%) 1 (3.0%) 69.7%
4. The product improved the elasticity of my facial skin.
33 3 (9.1%) 17 (51.5%) 11 (33.3%) 1 (3.0%) 1 (3.0%) 60.6%
5. The product lifted my facial skin and improved the appearance of sagging in my face.
33 3 (9.1%) 12 (36.4%) 15 (45.5%) 2 (6.1%) 1 (3.0%) 45.5%
6. The product tightened my facial skin.
33 3 (9.1%) 15 (45.5%) 14 (42.4%) 0 (0.0%) 1 (3.0%) 54.5%
7. The product improved the appearance of lines/ wrinkles on my crow’s feet area.
33 1 (3.0%) 13 (39.4%) 16 (48.5%) 2 (6.1%) 1 (3.0%) 42.4%
8. The product improved the appearance of lines/ wrinkles on my facial skin.
33 2 (6.1%) 12 (36.4%) 16 (48.5%) 2 (6.1%) 1 (3.0%) 42.4%
9. My facial skin appears less dull and more radiant after using the product.
33 4 (12.1%) 17 (51.5%) 10 (30.3%) 1 (3.0%) 1 (3.0%) 63.6%
10. The product improved the appearance of my facial skin, illuminating my complexion with a fresh youth infused glow.
33 2 (6.1%) 18 (54.5%) 10 (30.3%) 2 (6.1%) 1 (3.0%) 60.6%
11. The product enhanced the overall appearance of my facial skin.
33 4 (12.1%) 17 (51.5%) 9 (27.3%) 2 (6.1%) 1 (3.0%) 63.6%
12. I did not experience any irritation after product application.
33 16 (48.5%) 15 (45.5%) 2 (6.1%) 0 (0.0%) 0 (0.0%) 93.9%
Question n Response n (%) Percent
Responding Favorably
Strongly Agree
Agree Neutral Disagree Strongly Disagree
N/A
13. I felt there was a relief in my actinic keratosis (scaly, crusty lesion).
14* 3
(20.0%) 4
(26.7%) 6
(40.0%) 1
(6.7%) 0
(0.0%) 19 50.0%
Bold/ Shaded = the majority of subjects responded favorably, >50% *Only subjects included in the Actinic Keratosis group (n=15) were included in the analysis.
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Table 5.0 Subjective Questionnaire – Regimen – Consumer Perception (Continued)
Question n
Week 4 Percent
Responding Favorably
Response n (%) Strongly
Agree Agree Neutral Disagree
Strongly Disagree
1. The product reduced the capillary redness of my facial skin.
32 5 (15.6%) 9 (28.1%) 14 (43.8%) 4 (12.5%) 0 (0.0%) 43.8%
2. The product improved the laxity (droopiness) of my eyelid.
32 4 (12.5%) 9 (28.1%) 16 (50.0%) 3 (9.4%) 0 (0.0%) 40.6%
3. The product improved the firmness of my facial skin.
32 4 (12.5%) 18 (56.3%) 7 (21.9%) 2 (6.3%) 1 (3.1%) 68.8%
4. The product improved the elasticity of my facial skin.
32 5 (15.6%) 18 (56.3%) 7 (21.9%) 2 (6.3%) 0 (0.0%) 71.9%
5. The product lifted my facial skin and improved the appearance of sagging in my face.
32 4 (12.5%) 12 (37.5%) 14 (43.8%) 2 (6.3%) 0 (0.0%) 50.0%
6. The product tightened my facial skin.
32 5 (15.6%) 17 (53.1%) 8 (25.0%) 2 (6.3%) 0 (0.0%) 68.8%
7. The product improved the appearance of lines/ wrinkles on my crow’s feet area.
32 5 (15.6%) 7 (21.9%) 17 (53.1%) 3 (9.4%) 0 (0.0%) 37.5%
8. The product improved the appearance of lines/ wrinkles on my facial skin.
32 4 (12.5%) 11 (34.4%) 14 (43.8%) 3 (9.4%) 0 (0.0%) 46.9%
9. My facial skin appears less dull and more radiant after using the product.
32 6 (18.8%) 17 (53.1%) 7 (21.9%) 2 (6.3%) 0 (0.0%) 71.9%
10. The product improved the appearance of my facial skin, illuminating my complexion with a fresh youth infused glow.
32 5 (15.6%) 15 (46.9%) 11 (34.4%) 1 (3.1%) 0 (0.0%) 62.5%
11. The product enhanced the overall appearance of my facial skin.
32 6 (18.8%) 19 (59.4%) 6 (18.8%) 1 (3.1%) 0 (0.0%) 78.1%
12. I did not experience any irritation after product application.
32 13 (40.6%) 15 (46.9%) 3 (9.4%) 1 (3.1%) 0 (0.0%) 87.5%
Question n Response n (%) Percent
Responding Favorably
Strongly Agree
Agree Neutral Disagree Strongly Disagree
N/A
13. I felt there was a relief in my actinic keratosis (scaly, crusty lesion).
12*^ 1
(8.3%) 4
(33.3%) 6
(50.0%) 1
(8.3%) 0
(0.0%) 20 41.7%
Bold/ Shaded = the majority of subjects responded favorably, >50% *Only subjects included in the Actinic Keratosis group (n=14) were included in the analysis. ^1 subject (#2) responded with an NA for question 13 and subject #33 did not attend the Week 4 visit (12 subjects analyzed).
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Table 5.0 Subjective Questionnaire – Regimen – Consumer Perception (Continued)
Question n
Week 8 Percent
Responding Favorably
Response n (%) Strongly
Agree Agree Neutral Disagree
Strongly Disagree
1. The product reduced the capillary redness of my facial skin.
33 8 (24.2%) 11 (33.3%) 12 (36.4%) 2 (6.1%) 0 (0.0%) 57.6%
2. The product improved the laxity (droopiness) of my eyelid.
33 4 (12.1%) 15 (45.5%) 11 (33.3%) 3 (9.1%) 0 (0.0%) 57.6%
3. The product improved the firmness of my facial skin.
33 9 (27.3%) 17 (51.5%) 5 (15.2%) 2 (6.1%) 0 (0.0%) 78.8%
4. The product improved the elasticity of my facial skin.
33 5 (15.2%) 17 (51.5%) 10 (30.3%) 1 (3.0%) 0 (0.0%) 66.7%
5. The product lifted my facial skin and improved the appearance of sagging in my face.
33 6 (18.2%) 12 (36.4%) 14 (42.4%) 1 (3.0%) 0 (0.0%) 54.5%
6. The product tightened my facial skin.
33 8 (24.2%) 17 (51.5%) 7 (21.2%) 1 (3.0%) 0 (0.0%) 75.8%
7. The product improved the appearance of lines/ wrinkles on my crow’s feet area.
33 6 (18.2%) 12 (36.4%) 13 (39.4%) 2 (6.1%) 0 (0.0%) 54.5%
8. The product improved the appearance of lines/ wrinkles on my facial skin.
33 6 (18.2%) 10 (30.3%) 15 (45.5%) 2 (6.1%) 0 (0.0%) 48.5%
9. My facial skin appears less dull and more radiant after using the product.
33 9 (27.3%) 18 (54.5%) 5 (15.2%) 1 (3.0%) 0 (0.0%) 81.8%
10. The product improved the appearance of my facial skin, illuminating my complexion with a fresh youth infused glow.
33 7 (21.2%) 17 (51.5%) 8 (24.2%) 1 (3.0%) 0 (0.0%) 72.7%
11. The product enhanced the overall appearance of my facial skin.
33 7 (21.2%) 18 (54.5%) 7 (21.2%) 1 (3.0%) 0 (0.0%) 75.8%
12. I did not experience any irritation after product application.
33 21 (63.6%) 9 (27.3%) 3 (9.1%) 0 (0.0%) 0 (0.0%) 90.9%
Question n Response n (%) Percent
Responding Favorably
Strongly Agree
Agree Neutral Disagree Strongly Disagree
N/A
13. I felt there was a relief in my actinic keratosis (scaly, crusty lesion).
13*^ 2
(15.4%) 4
(30.8%) 6
(46.2%) 1
(7.7%) 0
(0.0%) 20 46.2%
Bold/ Shaded = the majority of subjects responded favorably, >50% *Only subjects included in the Actinic Keratosis group (n=14) were included in the analysis. ^1 subject (#2) responded with an NA for question 13 (13 subjects analyzed).
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19.2 Discussion
19.2.1 Enrollment and Demographics
At least 30 female subjects, ages 35 and 59 years old, were required to complete study participation. The study completed with 33 female subjects with an age range of 35 to 60 with an average age of 51.51 years old. The population’s ethnicity was 81.8% Non-Hispanic or Latino and 18.2% Hispanic or Latino. The population’s reported race was 81.8% White, 15.2% No Response (Hispanic or Latino) and 3.0% African American or Black.
19.2.2 Expert Visual Grading
Catalyst AC-11:
Analysis of results revealed statistically significant improvement from Baseline in mean scores for the appearance of facial skin’s texture/smoothness (visual), fine lines/wrinkles-crow’s feet, radiance / luminosity, eyelid laxity, elasticity (tactile), overall appearance, capillary visibility and actinic keratosis severity immediately after use.
Of particular note, immediate improvement in the appearance of fine lines/wrinkles – crow’s feet was seen in 100 percent of subjects and more than 90 percent showed immediate improvement in the appearance of skin texture/smoothness (visual), radiance/luminosity and elasticity (tactile).
Regimen:
Analysis of results revealed statistically significant improvement from Baseline in mean scores for the appearance of facial skin’s texture/smoothness (visual), fine lines/wrinkles-crow’s feet, radiance / luminosity, eyelid laxity, elasticity (tactile), overall appearance, capillary visibility and actinic keratosis severity after 8 weeks of use. Further statistically significant improvement from Baseline was observed in mean score for overall appearance at Weeks 1 and 4, and for radiance / luminosity, eyelid laxity and capillary visibility at Week 4.
Further, 100 percent of subjects showed improvement from Baseline to Week 8 in results for the appearance of radiance/luminosity and overall appearance, and more than 90 percent showed improvement from Baseline to Week 8 in results for the appearance of actinic keratosis severity.
Statistically significant worsening from Baseline was observed in mean score for the appearance of facial skin’s fine lines/wrinkles-crow’s feet at the Week 1 visit.
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19.2.3 Instrumental Assessments
Catalyst AC-11:
Cutometer: No Statistically significant improvements from Baseline were observed in mean Cutometer results for skin firmness or skin elasticity immediately following product application.
Regimen:
Cutometer: Statistically significant improvements from Baseline were observed in mean Cutometer results for skin firmness at the Week 8 visit and for skin elasticity at the Week 4 and Week 8 visits.
Statistically significant improvement from Baseline was observed in SIAscope results for skin hemoglobin at the Week 4 and 8 visits. Alternately, statistically significant worsening from Baseline was observed in SIAscope results for hemoglobin at Week 1.
19.2.4 Subjective Questionnaire
Catalyst AC-11:
The majority of subjects (>50%) responded favorably (“agree” or “strongly agree”) to the statements “The product immediately improved the firmness of my facial skin”, “The product immediately improved the elasticity of my facial skin”, “The product immediately tightened my facial skin”, “My facial skin appears less dull and more radiant immediately after using the product” and “I did not experience any irritation after product application”.
Regimen:
At Weeks 1, 4 and 8 the majority of subjects responded favorably to questions regarding improvement in the appearance of facial skin’s firmness, elasticity, tightness, radiance, youthful complexion and its overall appearance. The majority also indicated that they did not experience any irritation.
Further, at Week 8, the majority of subjects responded favorably to questions regarding improvement in the appearance of capillary redness, eyelid laxity, facial sagging and lines/wrinkles – crow’s feet area.
20.0 Conclusion
In conclusion, under the conditions of this study, use of Catalyst AC–11 #OS-PRD-CAC-030 alone and of a regimen consisting of Purify #OS-PRD-PUR-200; Catalyst AC–11 #OS-PRD-CAC-030; Spritz Clear Plus #OS-PRD-CLR-100; Quench Plus #OS-PRD-QUE-031 led to significant improvements in skin appearance and condition as evidenced by results from expert clinical grading, instrumental assessments and subjective questionnaire results.
Catalyst AC–11 #OS-PRD-CAC-030: Expert clinical grading revealed immediate, statistically significant improvements in the appearance of facial skin’s texture/smoothness (visual), fine lines/wrinkles-crow’s feet, radiance / luminosity, eyelid laxity, elasticity (tactile), overall appearance, capillary visibility and actinic keratosis severity. Subjective questionnaire results revealed that the majority of subjects
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believed that its use resulted in immediate improvements in the appearance of facial skin’s firmness, elasticity, tightness and radiance, and that the product did not cause them any skin irritation.
Test Product Regimen: Purify #OS-PRD-PUR-200; Catalyst AC–11 #OS-PRD-CAC-030; Spritz Clear Plus #OS-PRD-CLR-100; Quench Plus #OS-PRD-QUE-031: Statistically significant improvements were observed in expert clinical grading results for overall (facial) appearance after one and four weeks of use, for radiance / luminosity, eyelid laxity and capillary visibility after four weeks of use and for texture/smoothness (visual), fine lines/wrinkles-crow’s feet, radiance / luminosity, eyelid laxity, elasticity (tactile), overall appearance, capillary visibility and actinic keratosis severity after eight weeks of use.
Instrumentally, improvement in skin’s elasticity was observed after four weeks of use, and improvements in both firmness and elasticity were observed after repeated applications for eight weeks.
Subjective questionnaire results revealed that the majority of subjects believed that its use resulted in improvements in the appearance of facial skin’s firmness, elasticity, tightness and radiance, and that the product did not cause them any skin irritation after one, four and eight weeks of use, and also resulted in improvements in the appearance of facial skin’s capillary redness, eyelid laxity, facial sagging and lines/wrinkles – crow’s feet area after eight weeks of use.
IRSI, Inc. Protocol No. 3931OSM0415 FINAL Report Ver. 2.2 October 21, 2015
CONFIDENTIAL Appendix I
Appendix I
Protocol
IRSI, Inc. Protocol No. 3931OSM0415 Final Protocol Ver. 2.6 June 29, 2015
CONFIDENTIAL 2
Study Summary
Title An eight-week clinical study to evaluate the efficacy of a regimen of topical products on skin condition
Protocol Number 3931OSM0415
Sponsor Osmosis, LLC
Methodology Monadic
Objective To evaluate the efficacy of one product to improve skin appearance and condition
Number of Subjects 30 to complete, target enrollment 35
Target Population Female subjects, age 35-59 years old
Duration 8 Weeks + 1 week washout (Screening/Washout (T-7D), Baseline, Week 1, Week 4, Week 8)
Claims
Claims to be assessed immediately after application of the Catalyst AC-11 product and after prolonged use of the topical product regimen
Claim Support
Reduces capillary redness and capillary visibility
Expert Clinical Grading SIAScope Subjective Questionnaires Photo Documentation (n=5)
Improves skin elasticity and firmness
Expert Clinical Grading (elasticity only) Subjective Questionnaires Cutometer
Improves eyelid laxity Expert Clinical Grading Subjective Questionnaires Photo Documentation (n=5)
Improves the appearance of lines/wrinkles
Improves skins overall appearance, radiance and luminosity
Study Products
Name Formula Number
Purify OS-PRD-PUR-200
Catalyst AC - 11 OS-PRD-CAC-030
Spritz Clear Plus OS-PRD-CLR-100
Quench Plus OS-PRD-QUE-031
Supportive Products Dove Beauty Bar, White Purpose Dual Treatment Moisture Lotion with SPF 15
NA NA
Statistical Methodology
Descriptive statistics reported for demographics, instrumental and visual assessments. Monadic data analyses will use paired t-test to determine significance of change from Baseline. Questionnaire response frequencies and mean indicated percent improvement reported for each question. All final statistical analyses will be performed on the PP population, significance set at p≤0.05.
Study Schedule Initiation: Consent / Washout June 8, 2015
Baseline June 15, 2015
Week 1 June 22, 2015
Week 4 July 13, 2015
Completion: Week 8 August 10, 2015
Intermediate Topline: Week 4 July 27, 2015
Final Topline: Week 8 August 24, 2015
Photographs: September 15, 2015
Draft Final Report: September 15, 2015
*Delivery dates subject to change ± 2 business days
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Table of Contents
1.0 Introduction ...................................................................................................................................... 5
2.0 Objectives.......................................................................................................................................... 5
3.0 Study Design...................................................................................................................................... 5
4.0 Products ............................................................................................................................................ 6
5.0 Population ......................................................................................................................................... 8
6.0 Methods ............................................................................................................................................ 9
7.0 Procedure ........................................................................................................................................ 13
8.0 Concomitant Medications and Products ........................................................................................ 15
9.0 Adverse Events ................................................................................................................................ 16
10.0 Institutional Review Board .............................................................................................................. 17
11.0 Informed Consent ........................................................................................................................... 17
12.0 Discontinuation of Study ................................................................................................................. 17
13.0 Changes to the Protocol .................................................................................................................. 17
14.0 Monitoring ...................................................................................................................................... 18
15.0 Recording of Data ........................................................................................................................... 18
16.0 Quality Control and Quality Assurance ........................................................................................... 18
17.0 Ethics ............................................................................................................................................... 19
18.0 Statistical Methods ......................................................................................................................... 19
19.0 Reporting of Results ........................................................................................................................ 19
20.0 Record Retention ............................................................................................................................ 20
21.0 Publication Policy ............................................................................................................................ 20
22.0 References ...................................................................................................................................... 20
Appendices Appendix I Product Use Instructions and Diary
Appendix II Subjective Questionnaire
Appendix III Case Report Forms Appendix IV Informed Consent Form and Model Release Form Appendix V Randomization Code(s)
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List of Abbreviations
AE BL C cm CRF CFR D FDA GCP HIPAA ICF ICH IND IRB IRSI AIDS n NDA PI PP SAE SOP Sponsor T15m US VAS W1 W4 W8 X
Adverse Event Baseline Collect Centimeter Case Report Form Code of Federal Regulations Dispense Food & Drug Administration Good Clinical Practices Health Insurance Portability and Accountability Act Informed Consent Form International Conference on Harmonization Investigational New Drug Institutional Review Board International Research Services, Inc. Acquired Immunodeficiency Syndrome Number of Subjects New Drug Application Principal Investigator Per-Protocol Serious Adverse Event Standard Operating Procedure Osmosis, LLC Immediate, approximately 15 minutes post-application United States Visual Analogue Scale Week 1 Week 4 Week 8 Times
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1.0 Introduction
This document is a protocol for a human research study. This study will be conducted according to International Research Services, Inc. research policies and Standard Operating Procedures, U.S. and international standards of Good Clinical Practice (FDA and ICH guidelines) and applicable government regulations.
1.1 Background
The face holds an integral role in human social communication and how humans are perceived as attractive. In addition to structural facial features, studies have shown that skin appearance is highly weighed in the perception of beauty and is determined primarily by its coloration and surface topography.1 Aging is caused by two processes, intrinsic and extrinsic. The sun is the primary cause of extrinsic aging and has also been shown to alter the normal course of intrinsic or natural aging.2 Current treatments for photoaged skin are offered in a variety of methods including non-invasive and invasive medical procedures, chemical peels, topical prescription and cosmetic products, most of which are intended to resurface the epidermis.3 As the need for efficacious treatments available to the consumer is evident, this study intends to investigate the effects of a product intended to improve the appearance and condition of facial skin.
Osmosis, LLC (Sponsor) has contracted with IRSI to develop and perform a clinical protocol designed to test the effects of a product regimen on facial skin in a population of female subjects, all of whom have photodamaged skin.
2.0 Objectives
2.1 Primary Objective
This study will determine the efficacy of a topical product regimen including four products intended to improve facial skin appearance and condition.
2.2 Secondary Objective
This study will determine the immediate efficacy of one topical product intended to improve facial skin appearance and condition.
3.0 Study Design
This is an eight-week monadic clinical study to evaluate the efficacy of an individual product for immediate results and a topical product regimen for eight weeks. Data will be analyzed for signs of improvement in facial skin condition and appearance in female subjects who have photodamaged skin. Assessments will include expert clinical visual grading, instrumental assessments and photographic documentation. Subjects’ perception of product effects will be captured via subjective questionnaire. The treatment products will be used daily per Sponsor instructions by all subjects for eight weeks. At least 30 subjects are expected to complete study participation. The study will be preceded by a one-week washout period, within which subjects will discontinue use of all facial cleansers and moisturizers and use only support product on their faces, as directed by IRSI.
Study visits will occur at Screening/ Washout (T-7D), Baseline (BL), Immediate (T15m) and at Weeks 1, 4 and 8 (W1, W4 and W8). A detailed outline of study visits appears in Section 7.0.
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3.1 Claims:
Assessment and questionnaire data will be analyzed with particular regard to the following desired key product effects for the regimen of four products after prolonged use:
1. Reduces capillary redness and capillary visibility, as determined by expert clinical grading, SIAScope, subjective questionnaires and photo documentation.
2. Improves elasticity and firmness, as determined by expert clinical grading (elasticity only), Cutometer and subjective questionnaires.
3. Improves eyelid laxity, as determined by expert clinical grading, subjective questionnaires and photo documentation.
4. Improves the appearance of lines/wrinkles, as determined by expert clinical grading, subjective questionnaires and photo documentation.
5. Improves skins overall appearance, radiance and luminosity, as determined by expert clinical grading, subjective questionnaires and photo documentation.
3.2 Claims (Catalyst AC-11)
Assessment and questionnaire data will be analyzed with particular regard to the following desired key product effects for the Catalyst AC-11 cream after a single application:
1. Immediately reduces capillary redness and capillary visibility, as determined by expert clinical grading, subjective questionnaires and photo documentation.
2. Immediately improves eyelid laxity, as determined by expert clinical grading, subjective questionnaires and photo documentation.
3. Immediately improves elasticity and firmness, as determined by expert clinical grading (elasticity only), Cutometer and subjective questionnaires (elasticity only).
4. Immediately improves the appearance of lines/wrinkles, as determined by expert clinical grading, subjective questionnaires and photo documentation.
5. Immediately improves skins overall appearance, radiance and luminosity, as determined by expert clinical grading, subjective questionnaires and photo documentation.
4.0 Products
The test products will be provided by the Sponsor and will bear appropriate coding labels and proper use instructions. Supportive product(s) will be provided by IRSI. Study products will be stored in a secure location and unused test product will be returned to Sponsor or discarded upon issue of final report in accordance with IRSI’s SOP.
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4.1 Product Descriptions
Name Designation Formula Number
Study Product
Purify Cleanser OS-PRD-PUR-200
Catalyst AC-11 Gel OS-PRD-CAC-030
Spritz Clear Plus Enhancer OS-PRD-CLR-100
Quench Plus Moisturizer OS-PRD-QUE-031
Supportive Products
Dove Beauty Bar, White Washout Cleanser NA
Purpose Dual Treatment Moisture Lotion with SPF 15 SPF Moisturizer NA
4.2 Product Use Instructions
Subjects will be provided with Support Washout Cleanser and SPF Moisturizer approximately seven days before Baseline.
At Baseline, subjects will discontinue the use of the Support Washout Cleanser and SPF Moisturizer and will be provided with the test product regimen to use for the duration of the study.
At the Baseline visit, all subjects will apply the Catalyst AC-11 product only to the face following Sponsor instructions under IRSI technician supervision.
Sponsor-provided use instructions will be explained to subjects and will be provided to each subject in their printed Study Instructions (See Appendix I).
Test Product Directions:
Use the test products twice daily, morning and evening in the following sequence:
Step 1: Wash face with Purify:
Apply ½ pump into palm of hand and lather face and neck with warm water, thoroughly Cleanse and rinse until all product has been removed. Dry skin with a soft towel.
Step 2: Apply Catalyst AC-11
Apply two pumps into hand and massage onto face and neck thoroughly. Massage into skin thoroughly.
Step 3: Spritz Clear Plus:
Spray Clear Plus 3-5 times onto face and neck and massage skin again until all product is absorbed into skin. This step is essential to ensure Catalyst AC-11 is fully absorbed.
Step 4: Quench Plus:
Apply 1-2 pumps Quench Plus into hand and massage onto entire face and neck.
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Support Product Directions:
Washout Period (T-7d):
Washout Cleanser: Use daily in place of your normal facial cleanser.
SPF Moisturizer: Apply daily in the morning prior to sun exposure, reapply every 2 hours as needed throughout the day during sun exposure during the washout period.
Study Period: Per sponsor, no sunscreen is permitted for use during study period.
Avoid sun exposure to the face, no sunscreen use is permitted, use hats and/or umbrellas when going into sun.
5.0 Population
5.1 Sample Size
The sample size of n=30 was requested by the Sponsor. A sufficient number of subjects will be enrolled in order to complete this study with no less than 30 subjects. The target enrollment is 35 subjects.
5.2 Inclusion Criteria
1. Females, in good general health, and between the ages of 35 and 59 years old, inclusive, at time of enrollment.
2. Subjects with lines and wrinkles and eyelid laxity as determined by an expert grader at Baseline.
a. Score of ≥2 cm on 10 cm VAS for fine lines/wrinkles (crow’s feet) b. Score of ≥2 cm on 10 cm VAS for eyelid laxity
3. A portion of the panel (approximately n=10) with Capillary visibility (telangiectasia) a. Score of ≥2 cm on 10 cm VAS for capillary visibility
4. A portion of the panel (approximately n=10) with actinic keratosis as determined by an expert grader at baseline.
a. Score of ≥2 cm on 10 cm VAS for actinic keratosis severity 5. Willing to be photographed and sign a photograph release form. 6. Able to read, understand and willing to sign an ICF, including HIPAA and state requirements,
complete a brief personal/medical history 7. Dependable and willing to attend study visits and comply with all study instructions and
requirements, including but not limited to: a. Willing to abstain from any other superficial or deep facial procedure during the
study (dermabrasion, microdermabrasion, peels, photo facials, laser treatment, facial lesion removal, etc.).
b. Willing to abstain from use of all other topical products for the duration of the washout period and study period.
c. Willing to abstain from the use of tanning bed use and recreational sun exposure on the face for the duration of the washout period and study period.
5.3 Exclusion Criteria
1. Subjects using systemic or topical steroids, Accutane, oral or topical estrogens, and/or other
medicines affecting skin in a major way during study period or washout period.
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2. Subjects with present or previous inflammatory or other skin diseases, such as rosacea,
severe acne, Systemic Lupus Erythematosus (SLE), dermatomyositis, scleroderma, etc.
3. Current or Smokers within one month prior to enrollment
General exclusion criteria:
4. Subjects participating in any other clinical studies
5. Subjects having an acute or chronic disease or medical condition, including dermatological
problems, which could put her at risk in the opinion of the Principal Investigator or
compromise study outcomes. Typical uncontrolled chronic or serious diseases and
conditions which would prevent participation in any clinical trial are cancer, AIDS, diabetes,
morbid obesity, renal impairment, mental illness, drug/alcohol addiction.
6. Subjects who are unreliable or unlikely to be available for the duration of the study
7. History of allergic reactions, skin sensitization and/or known allergies to cosmetic
ingredients, toiletries, sunscreens, etc.
8. Immunocompromised subjects
9. Woman who started Hormone Replacement Therapy within the last three months preceding
the screening visit
10. Woman using oral contraception for less than three months before the screening visit or who
has changed her contraceptive method within the three months before the Baseline visit or
planning to modify her contraception treatment within the duration of the study
11. Woman known to be pregnant, lactating or planning to become pregnant within six months.
Subjects who become pregnant during the study must inform the Principal Investigator
immediately
12. Individuals unable to communicate or cooperate with the Principal Investigator due to
language problems, poor mental development, or impaired cerebral function
13. Employees of IRSI or other testing firms/ laboratories, cosmetic or raw goods manufacturers
or suppliers
6.0 Methods
6.1 Expert Grading Assessments for Efficacy
Visual Analog Scales (VAS) are commonly used in clinical research to measure intensity or frequency of various symptoms, subjective characteristics or attitudes that cannot be directly measured. VAS are a reliable scale and more sensitive to small changes than simple ordinal scales.4 When responding to a VAS item, the expert grader specifies their level of agreement to a statement by indicating a position along a line (10 cm) between two end-points or anchor responses. Simple VAS will be used to evaluate efficacy parameters in which the ends of a 10 cm horizontal line will be defined as extreme limits orientated from the left (best) to the right (worst).
All subjects will have facial skin texture /smoothness (visual), lines/wrinkles (crow’s feet), elasticity (tactile), eyelid laxity, radiance/luminosity, and overall appearance assessed by an expert grader at BL, T15m, W1, W4 and W8. A portion of the panel which presents with capillary visibility and Actinic Keratosis at Baseline will be assessed by an expert grader for these attributes at BL, T15m, W1, W4 and W8.
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The same expert grader will assess the same subjects at every time point. Clinical grading will be performed in the same room at each study visit using overhead lighting as well as a lighted magnifying loop as needed. Natural sunlight will be blocked from the room to ensure the same lighting conditions at each time point.
The following IRSI-developed VAS will be used:
Texture / Smoothness - Visual
0 cm 10 cm Smooth, even
surface appearance
Rough, uneven surface
appearance
Fine Lines/Wrinkles (Crow’s Feet)
0 cm 10 cm
None
Numerous lines/ Wrinkles –
Severe, Deep
Radiance / Luminosity
0 cm 10 cm Radiant,
Luminous appearance
Dull/Matte
and/or Sallow
Eyelid Laxity
0 cm 10 cm Taut,
“awake”, smooth eyelid
Sagging, “tired”,
drooping eyelid
Elasticity (tactile)
0 cm 10 cm Good
Stretch and Bounce back
Poor Stretch and Bounce
back
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Overall Appearance
0 cm 10 cm Vibrant, Healthy
appearance
Aged, Unhealthy
appearance
Capillary Visibility*
0 cm 10 cm
None *Only grade if subject presents this at Baseline (portion of panel)
Highly visible,
intense red capillary
Actinic Keratosis Severity*
0 cm 10 cm
None *Only grade if subject presents this at Baseline (portion of panel) Highly visible
patches
6.2 Instrumental Evaluations
Test environment temperature (°F) and humidity (%) will be recorded in every room used for study conduct every hour. Additionally, once-daily outdoor conditions will be recorded for each visit.
6.2.1 COSMETRICS™ SIAscope
The COSMETRICS™ SIAScope (Astron Clinica, Toft, UK) is a non-invasive optical skin imaging instrument using Spectrophotometric Intracutaneous Analysis (SIA), or chromophore mapping. The technique is based on a unique combination of dermatoscopy and contact remittance spectrophotometry. The hardware consists of a hand-held imaging probe attached to a laptop computer. The unit is placed in contact with the skin surface and high-intensity LED’s illuminate the skin as discreet wavelengths of 400 to 1000nm, spanning the visible spectrum and a small range of the near infrared spectrum. A digital image is captured for each wavelength.
Three parametric chromophore maps are retrieved up to 2 mm in depth and 11 mm in circumference, one for each of the following parameters: epidermal melanin, dermal hemoglobin and dermal collagen.
For this study, dermal hemoglobin measurements will be taken in duplicate and averaged on a spot determined at Baseline with visible red capillaries if applicable or on the cheek if no capillaries visible, at BL, W1, W4 and W8. The same location will be measured at each time point and recorded using a face map.
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6.2.2 CUTOMETER
The Cutometer MPA 580 (Courage + Khazaka, Germany) measures the viscoelastic properties of the skin by applying suction to the skin surface, drawing the skin into the aperture of the probe and determining the penetration depth using an optical measuring system.
The resistance of the skin to be sucked up by the negative pressure (firmness) and its ability to return to its original position (elasticity) are calculated and displayed as curves. The Cutometer outputs include many parameters of different portions of the measurement curve including of R0 (Uf, firmness), R2 (Ua/Uf, gross elasticity), R5 (Ur/Ue, net elasticity), R7 (Ur/Uf, elastic portion) and R9 (R3[last max amp]-R0[Uf], fatigue).
Skin Elasticity will be reported using the R5 (Ur/Ue) parameter, as the skin becomes more elastic this value will increase. Skin Firmness will be reported using the R0 (Uf) parameter, as the skin becomes firmer this value will decrease.
All subjects will have Cutometer measurements taken on their left or right cheek, as determined by a randomization code, in duplicate and averaged at BL, T15m, W1, W4 and W8. Assessment location will be recorded on a face map for each subject.
6.3 Photography
All clinical photography is performed in accordance with IRSI’s SOP to ensure reproducibility of high quality images throughout the duration of the study. Imaging is conducted in a designated photography suite with a matte black wall and all natural light is blocked out. To prepare subjects for clinical photography, subjects will be asked to remove all jewelry, including earrings, necklaces and any facial jewelry. A trained technician will inspect the subjects under a lighted magnification loop to ensure no residual color cosmetics or skincare products are visible on the face, eyes or lips. Subjects will be provided with a black cape and black headband and will be instructed on placement to ensure all hair is pulled back neatly and covered.
6.3.1 Clarity™ 2D Research System Ti
The Clarity™ 2D Research System Ti (Clarity) (BrighTex Bio-Photonics (BTBP), San Jose CA, USA) captures high quality full face frontal, left and right lateral images. Three cameras within the system allow for 18 megapixel SLR image capture in 16-bit simultaneously using a live feed display and automated facial alignment checks against baseline images for reproducibility.
A subgroup of five (N=5) subjects chosen at random will have Left, Right and Center facial images captured at BL, W1, W4 and W8. Photographs will be for documentation purposes only.
6.4 Subjective Questionnaire
Subjective questionnaires allow the Sponsor to gauge the subjects’ opinions of the test product and its effects. Questions will ask for subjects’ agreement to a statement with a five point scale, IRSI will provide questionnaire and perform analysis (See Appendix II).
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Subjects will complete the questionnaire at T15m regarding Catalyst AC-11 immediate effects and again at W1, W4 and W8 regarding prolonged use of the four product regimen.
7.0 Procedure
7.1 Consent / Screening Visit / Washout
Potential subjects will come to the clinic approximately seven days prior to the Baseline visit to read and sign an informed consent form (ICF), as described in Section 11, a model release form, inclusion / exclusion criteria and to complete a brief personal/medical history.
Unless a response(s) on their medical history form, inclusion / exclusion criteria or ICF indicate that they are not qualified to participate in the study, each potential subject will receive the support Washout Cleanser and Washout SPF Moisturizer and instructions for its use during the seven-day washout period.
They will then receive an appointment time for their Baseline visit and will be dismissed from the consent / screening / washout visit.
7.2 Baseline Visit
Subjects will arrive at IRSI with clean facial skin, having washed their face and applied no topical treatment or cosmetic products within one hour prior to their visit.
Potential subjects will acclimate to clinic environment with their facial skin exposed for at least 15 minutes allowing subject to relax and let their skin balance to the environment.
Following acclimatization, potential subjects will be screened to determine if they meet study entrance criteria as described in Section 5.2 and 5.3.
The following Screening procedures will be performed and all findings will be reported on the appropriate CRFs:
- Review of compliance to washout, updated Medical History and inclusion / exclusion criteria.
- Expert visual evaluation for any skin condition which would disqualify subject from study enrollment.
- Expert visual evaluation for qualification according to inclusion criteria 4.a and 4.b, above, in section 5.2.
Subjects who meet entrance criteria as defined in Section 5.2 and 5.3 will be enrolled and proceed with study participation.
The following BL assessments will be performed and all findings will be reported on the appropriate CRFs:
- Expert visual grading as described in Section 6.1 - Instrumental assessments as described in Section 6.2 - Photography as described in Section 6.3
All subjects will be provided with the test product regimen along with instructions and diary to record use per section 4.2.
Subjects will apply the Catalyst AC-11 product to their face under supervision as described in Section 4.2.
Approximately 15 minutes post-application the following T15m assessments will begin and all findings will be reported on the appropriate CRFs:
- Expert visual grading as described in Section 6.1 - Instrumental assessments as described in Section 6.2
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- Subjective Questionnaire as described in Section 6.4 Subjects will be advised to inform the laboratory immediately if any adverse reactions are
experienced during the study. After all evaluations are completed, subjects will be given an appointment time for their Week 1
visit and will be dismissed from the Baseline visit.
7.3 Week 1, 4 and Week 8 Visits
Subjects will arrive at IRSI with clean facial skin, having washed their face and applied no topical treatment or cosmetic products within one hour prior to their visit.
Review of compliance to study instructions, updated Medical History Subjects will acclimate to clinic environment with their facial skin exposed for at least 15
minutes allowing subject to relax and let their skin balance to the environment. The following assessments will be performed and all findings will be reported on the appropriate
CRFs: - Expert visual grading as described in Section 6.1 - Instrumental assessments as described in Section 6.2 - Photography as described in Section 6.3 - Subjective Questionnaires as described in Section 6.4
Each subject’s products will be inspected to ensure product use compliance and/or that enough product remains for study duration, and diaries will be reviewed and/or subjects will be queried to detect any changes in subject’s health.
At W1 and W4, subjects will be advised to inform the laboratory immediately if any adverse reactions are experienced during the study.
At W1 and W4, after all evaluations are completed, subjects will be given an appointment time for their next visit and dismissed.
At W8, subjects will be advised to inform the laboratory immediately if any adverse reactions are experienced during the 48 hours following study completion.
At W8, after all evaluations are completed, subjects will return any unused products and/or empty containers and will be given a stipend for their participation and dismissed from the study.
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7.3.1 Procedure Summary Table
Procedures Screening/ Washout Baseline
Immediate Week 1 Week 4 Week 8
Study Initiation and Qualification
Informed Consent and Medical History
X
Inclusion/Exclusion Criteria reviewed
X X
Dispense/ Collect Products D
Support D
Test
C
Expert Clinical Grading
- Texture (visual) -Lines/Wrinkles (Crow’s Feet) - Radiance/ Luminosity -Eyelid Laxity -Elasticity -Overall Appearance -Capillary Visibility - Actinic Keratosis Severity
X X X X X
Instrumental Evaluation
SIAScope (hemoglobin)
X
X X X
Cutometer (elasticity,
firmness) X
X X X X
Photography Clarity 2DResearch Ti (n=5, L, R,C views)
X
X X X
Consumer Perception
Subjective Questionnaire
X
Catalyst AC-11 only
X X X
8.0 Concomitant Medications and Products
The use of any topical skin treatment products (other than those assigned during the study) on the face will be prohibited during the washout and study periods. This includes, but is not limited to moisturizers, serums, cleansers, sunscreens and medicated creams.
Use of superficial or deep facial procedures during the study is prohibited including dermabrasion, microdermabrasion, peels, photo facials, laser treatments, facial lesion removal.
Major medical procedures should be avoided including endoscopy or any procedure requiring sedation (if medically necessary subject will be discontinued from study participation).
The use of color cosmetics is allowed, no new personal care products should be introduced for the duration of the study.
Smoking is prohibited for the duration of the study.
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9.0 Adverse Events
Subjects will be advised to report all adverse events to the study personnel as soon as possible. An adverse event (AE) is any untoward medical occurrence experienced by a subject whether or not considered product related.
An adverse event must have an onset time after the subject is enrolled in the study and generally within one week after the subject's participation in the study has ended. The endpoint will depend on the nature of the product being tested.
An adverse event may consist of a:
Disease or injury Exacerbation of pre-existing illness or condition Recurrence of an intermittent illness or condition Set of related signs or symptoms Single sign or symptom
Adverse events will be recorded on the appropriate case report form and include the Principal Investigator's assessment of product relationship as follows:
0 = None 1 = Remote 2 = Possible 3 = Probable 4 = Definite
The Principal Investigator's assessment will be summarized in the final report.
9.1 Serious Adverse Events
A serious adverse event will be defined as any experience which is (any one or more of the following):
Fatal Life-threatening Persistent or significant disability/incapacity Required or prolongs inpatient hospitalization Results in congenital anomaly or birth defect
9.2 Reporting of Adverse Events
Adverse events will be documented on the appropriate form and reported to the Sponsor within five business days if any relationship to the product(s) is determined by the PI. The Sponsor will be notified of any serious adverse event (SAE) within 24 hours of recording the experience (when possible). Additionally, all AEs, serious / not serious, related / not related will be summarized in the final report and a copy of the AE form will be appended to the final report. Proper judgment will be exercised in deciding whether expedited reporting is appropriate in other situations, such as events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of
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the other outcomes listed in the definition above. These should also usually be considered serious (FDA 21 CFR., Vol. 62, No. 194, 52243). Examples are:
Overdose Intensive treatment in an emergency room or at home for allergic bronchospasm
Development of drug dependency or drug abuse
Sponsor Contact for Reporting AEs and SAEs Contact: Ben Johnson, MD Address: 30746 Bryant Drive Unit #410
Evergreen, CO 80439 Phone: 303.674.7660 E-Mail: [email protected]
IRSI staff and its Investigators do not assume Sponsor obligations for reporting SAEs to the FDA or other regulatory agencies.
10.0 Institutional Review Board
IRB review was not requested by the Sponsor for this study.
11.0 Informed Consent
The informed consent process will be completed prior to an individual’s involvement in any study related activity. The process will be documented using a written informed consent form (ICF) conforming to FDA 21 CFR 50.25 (See Appendix IV).
The study Principal Investigator or his designee will inform the individual of all aspects of the trial that are relevant to the subject’s decision to participate, and the individual will have the opportunity to have any questions answered. As part of the written consent, the subject will be informed that she has the right to discontinue participation in the study at any point. Subjects who are not capable of providing or are unwilling to provide voluntary informed consent will not be enrolled.
After review, two copies of the ICF will be signed and dated by the individual and the Principal Investigator or his designee administering the consent. One original copy will be retained by IRSI and the other will be given to the individual.
12.0 Discontinuation of Study
The Sponsor, Principal Investigator, and IRSI have the right to discontinue the study for medical, safety or administrative reasons at any time. Appropriate procedures will be followed to ensure the safe withdrawal of each subject from the study.
13.0 Changes to the Protocol
Upon Sponsor, Principal Investigator, Study Coordinator and IRB approval and signing, this study protocol is considered final. Changes to the protocol must be approved in writing by the Sponsor and Principal Investigator prior to implementation. It is the responsibility of the Primary Investigator and Study Coordinator to ensure the protocol is approved and followed in agreement with FDA 21 CFR Part 58 Sec. 58.33.
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Changes to the protocol will be categorized and documented as per IRSI’s SOP as follows: Protocol Amendment, Protocol Deviation: Major and Minor.
13.1 Protocol Amendments
A protocol amendment is any permanent change or written clarification to the study protocol. Amendments may be requested by the Sponsor, Principal Investigator or Study Coordinator.
Amendments to the protocol must be approved in writing by both the Principal Investigator and the Sponsor prior to implementation. The exception shall be when a change is required in the interest of subject protection or safety. In such instances, the sponsor shall be notified in writing within 24-hours of the change, whenever possible.
13.2 Protocol Deviations
A protocol deviation is any divergence or departure from the study protocol or a SOP. Deviations will be categorized by the Study Coordinator as Major or Minor.
A deviation is considered Major when there is a consistent variation in practice from the defined protocol or a subject has been identified as being at risk of harm in relation to their involvement in the study and urgent action, which deviates from the protocol, has occurred. Major deviations will be reported to the Sponsor within 24-hours (when possible) and corrective action (if necessary) will be identified.
A deviation is considered Minor when a variation to the protocol does not affect subject safety or the integrity of the research. Minor deviations will be documented throughout the study and reported to the Sponsor upon completion of the study.
14.0 Monitoring
IRSI will permit trial-related monitoring, audits, IRB review and regulatory inspections at any time. Access to all study documents, source documents and data will be available on site.
15.0 Recording of Data
All data and information, except electronically recorded data (Clarity, SIAScope, Cutometer), will be recorded on specific paper case report forms (CRFs) and this information will be neatly recorded in type or legibly printed in black ink wherever possible (See Appendix III). Any errors will be crossed out and the correct entry made and initialed and dated by the Principal Investigator or his designee, unless the CRF is also a source document completed by the subject (such as a questionnaire) in which case the correction will be made by the subject as described above.
16.0 Quality Control and Quality Assurance
IRSI will audit the study for accuracy, consistency and proper documentation in accordance to IRSI SOPs and practices. The auditor will verify the accuracy of results reported in the data listings and statistical analysis after each study visit. The data listings and database used for statistical analysis will be verified against the CRFs. The data listings will be verified against the CRFs for 100% of the data, in a randomly selected set of the subjects (25% of the total number of subjects). The statistical report(s) will be validated for accuracy and completeness, as well as verifying the correctness of all subject numbers (n) and the analyses performed according to the Statistical Analysis Plan as described in Section 18. The statistical topline tables will be reviewed and compared with the statistical report for accuracy.
IRSI, Inc. Protocol No. 3931OSM0415 Final Protocol Ver. 2.6 June 29, 2015
CONFIDENTIAL 19
17.0 Ethics
The study will be conducted in accordance with FDA GCP regulations and ICH guidelines in as much as they apply to cosmetic research with the following noted: This is not an IND / NDA clinical trial. IRSI does not assume any Sponsor obligations as stipulated in FDA GCP and ICH documents. This study is not intended for submission to the FDA.
18.0 Statistical Methods
The planned statistical analysis is outlined below for each type of data to be acquired.
The per-protocol (PP) population is defined as the subset of subjects that who complied with the protocol sufficiently to ensure that their data will be likely to exhibit the effects of the treatment. To be considered a PP subject, a subject cannot miss more than one study visit (excluding Baseline or Week 8) or be found to be non-compliant with the study protocol at the discretion of the Principal Investigator (PI).
The PP population will be used for statistical analysis at each time point. Statistical significance is set at p≤0.05.
Data Type Statistical Method Data Reported
Demographics Descriptive Statistics Mean and standard deviation Min and Max Frequency (number and percent)
Clinical Grading for Efficacy, Instrumental Evaluation
Descriptive Statistics Paired T-test (monadic),
Mean and standard deviation Mean percent improvement from Baseline Percent of subjects improving P-value vs. Baseline
Subjective Questionnaire Descriptive Statistics
Frequency tables (n and %) of each response Percent of subjects responding favorably.
19.0 Reporting of Results
A top line report (data only) will be issued electronically approximately ten business days after study completion as indicated below.
Clinical study photographs will be will be saved in .jpeg format and provided to the Sponsor on disc (or USB) approximately five weeks after study completion.
The final draft report will be issued electronically approximately five weeks after study completion. Upon Sponsor approval of the draft, the report will be finalized. If no request for revisions or approval is received from the Sponsor within six weeks after the issuance of the draft report, it will be considered final. Once finalized, the report will be issued on electronic media (USB flash drive or equivalent) via US Mail, additionally an electronic copy will be sent via email.
No data issued prior to the final signed report should be considered as final, further, the Sponsor agrees:
Not to make published claims based on this study prior to its completion and the rendering of a final report.
Not to misrepresent the results of the study.
IRSI, Inc. Protocol No. 3931OSM0415 Final Protocol Ver. 2.6 June 29, 2015
CONFIDENTIAL 20
Schedule Date
Initiation: Consent / Washout June 8, 2015
Baseline, Immediate June 15, 2015
Week 1 June 22, 2015
Week 4 July 13, 2015
Completion: Week 8 August 10, 2015
Deliverable Date of Expected Delivery*
Intermediate Topline (Week 4) July 27, 2015
Final Topline (Week 8) August 24, 2015
Photographs September 15, 2015
Draft Final Report September 15, 2015
*Delivery dates subject to change ± 2 business days
20.0 Record Retention
IRSI shall assume the Principal Investigator responsibilities of maintaining study records for a period of 2 years following the date a marketing application is approved for the test material(s) for the indication for which it is being tested; or, if no application is to be filed or if the application is not approved for such indication, until two years after the investigation is discontinued and FDA is notified, if required. Therefore for this study IRSI will archive the study records for a period of two years after the test is discontinued. Material may be archived in electronic or hard copy form. IRSI does not assume any Sponsor obligation regarding record retention or notification/submission to FDA. Prior to study initiation the Sponsor shall provide written notification to IRSI of any submissions to or approvals sought from FDA for the test materials being studied.
21.0 Publication Policy
Neither the complete nor any part of the results of the study carried out under this protocol, nor any of the information provided by the Sponsor for the purposes of performing the study, will be published or passed on to any third party without the consent of the Sponsor. Conversely, prior to publication or other public presentation of the results from this clinical study, the Sponsor should obtain consent from the Primary Investigator.
22.0 References 1 Samson, B. Fink and P. J. Matts, "Visible skin condition and perception of human facial appearance,"
International Journal of Cosmetic Science, vol. 32, pp. 167-184, 2010. 2 L. Baumann, "Skin aging and its treatment," Journal of Pathology, vol. 211, pp. 241-251, 2007. 3 M. H. Gold, J. Y. Hu, J. A. Biron, M. Yatskayer, A. Dahl and C. Oresajo, "Tolerability and efficacy of
retinoic acid given after full-face peel treatment in photodamaged skin," Journal of Clinical and Aesthetic Dermatiology, vol. 4, no. 101, pp. 40-48, 2011.
4 A. Paul-Dauphin, F. Guillemin, J. Virion and S. Briancon, "Bias and precision in visual analog scales: A randomized controlled trial," American Journal of Epidemiology, vol. 150, no. 10, pp. 1117-27, 1999.
IRSI, Inc. Protocol No. 3931OSM0415 Final Protocol Ver. 2.6 June 29, 2015
CONFIDENTIAL Appendix I
Appendix I
Product Use Instructions and Diary
Washout Instructions
Screening / Washout
Study Number 3931OSM0415
SUPPORT PRODUCTS USE INTRUCTIONS:
Facial Cleanser: Use Dove Beauty Bar, White in place of your normal facial cleanser
Facial SPF Moisturizer: Apply Purpose Dual Treatment Moisture Lotion with SPF 15 daily in the
morning prior to sun exposure, reapply every two hours as needed throughout the day during sun
exposure
STUDY RESTRICTIONS: DO NOT use any topical skin treatment products (other than those assigned during the study) on the face. This includes, but is not limited to moisturizers, serums, cleansers and medical creams. DO NOT use superficial or deep facial procedures during the study, including dermabrasion, microdermabrasion, peels, photo facials, laser treatments and facial lesion removal.
DO NOT undergo major medical procedures, including endoscopy or any procedure requiring sedation (if medically necessary, then subject will be discontinued from the study) DO NOT introduce new personal care products for the duration of the study
DO NOT smoke for the duration of the study You CAN use color-cosmetics which you were regularly using at the time of study enrollment during the study period.
Return to IRSI on Monday, June 15th at your scheduled time. A few important reminders for your next visit: Please make sure you have cleansed your facial and forearm skin, having washed your face and forearms and applied no topical treatment or cosmetic products, including the test products within one hour prior to your visit.
You will qualify ONLY if your skin shows signs of aging.
Remaining Visit Dates: Monday, June 15th Monday June 22nd Monday, July 13th
Monday, August 10th
If you have any questions, or are experiencing any problems with the provided products, then please call the coordinators at: Robigaile – (914) 937-6500 Ext. 132 or Reception – (914) 937 – 6500 Ext. 111
Thank you for your cooperation!
DIARY AND USAGE INSTRUCTIONS BASELINE THROUGH WEEK 8
Study Number: 3931OSM0415
Subject Initials:
Subject Number:
SUNDAY MONDAY TUESDAY WEDNESDAY THURSDAY FRIDAY SATURDAY
JUNE 15 BASELINE CLINIC VISIT
Product Used
____:___ pm
JUNE 16 Product Used
____:___am ____:___ pm
JUNE 17 Product Used
____:___am ____:___ pm
JUNE 18 Product Used
____:___am ____:___ pm
JUNE 19 Product Used
____:___am ____:___ pm
JUNE 20 Product Used
____:___am ____:___ pm
JUNE 21 Product Used
____:___am ____:___ pm
JUNE 22 Product Used
____:___am ____:___ pm
JUNE 23 Product Used
____:___am ____:___ pm
JUNE 24 Product Used
____:___am ____:___ pm
JUNE 25 Product Used
____:___am ____:___ pm
JUNE 26 Product Used
____:___am ____:___ pm
JUNE 27 Product Used
____:___am ____:___ pm
JUNE 28 Product Used
____:___am ____:___ pm
JUNE 29 Product Used
____:___am ____:___ pm
JUNE 30 Product Used
____:___am ____:___ pm
JULY 1 Product Used
____:___am ____:___ pm
JULY 2 Product Used
____:___am ____:___ pm
JULY 3 Product Used
____:___am ____:___ pm
JULY 4 Product Used
____:___am ____:___ pm
JULY 5 Product Used
____:___am ____:___ pm
JULY 6 Product Used
____:___am ____:___ pm
JULY 7 Product Used
____:___am ____:___ pm
JULY 8 Product Used
____:___am ____:___ pm
JULY 9 Product Used
____:___am ____:___ pm
JULY 10 Product Used
____:___am ____:___ pm
JULY 11 Product Used
____:___am ____:___ pm
JULY 12 Product Used
____:___am ____:___ pm
JULY 13 WEEK 4 CLINIC VISIT
WASH FACE
WITHIN ONE HOUR OF APPOINTMENT
DIARY AND USAGE INSTRUCTIONS WEEK 4 THROUGH WEEK 8
Study Number: 3931OSM0415
Subject Initials:
Subject Number:
PRODUCT USE INSTRUCTIONS CONTINUED ON BACK OF DIARY
SUNDAY MONDAY TUESDAY WEDNESDAY THURSDAY FRIDAY SATURDAY
JULY 13 WEEK 4 CLINIC VISIT
Product Used
___:___am ____:___ pm
JULY 14 Product Used
____:___am ____:___ pm
JULY 15 Product Used
____:___am ____:___ pm
JULY 16 Product Used
____:___am ____:___ pm
JULY 17 Product Used
____:___am ____:___ pm
JULY 18 Product Used
____:___am ____:___ pm
JULY 19 Product Used
____:___am ____:___ pm
JULY 20 Product Used
____:___am ____:___ pm
JULY 21 Product Used
____:___am ____:___ pm
JULY 22 Product Used
____:___am ____:___ pm
JULY 23 Product Used
____:___am ____:___ pm
JULY 24 Product Used
____:___am ____:___ pm
JULY 25 Product Used
____:___am ____:___ pm
JULY 26 Product Used
____:___am ____:___ pm
JULY 27 Product Used
____:___am ____:___ pm
JULY 28 Product Used
____:___am ____:___ pm
JULY 29 Product Used
____:___am ____:___ pm
JULY 30 Product Used
____:___am ____:___ pm
JULY 31 Product Used
____:___am ____:___ pm
AUGUST 1 Product Used
____:___am ____:___ pm
AUGUST 2 Product Used
____:___am ____:___ pm
AUGUST 3 Product Used
____:___am ____:___ pm
AUGUST 4 Product Used
____:___am ____:___ pm
AGUUST 5 Product Used
____:___am ____:___ pm
AGUUST 6 Product Used
____:___am ____:___ pm
AGUUST 7 Product Used
____:___am ____:___ pm
AUGUST 8 Product Used
____:___am ____:___ pm
AUGUST 9 Product Used
____:___am ____:___ pm
AUGUST 10 WEEK 8 CLINIC VISIT
WASH FACE
WITHIN ONE HOUR OF APPOINTMENT
DIARY AND USAGE INSTRUCTIONS
Study Number: 3931OSM0415
Subject Initials:
Subject Number:
Test Product Directions: Apply as directed - see attached sponsor provided instructions
Reminders for your next visit: Bring product and diary
Wash your face within the hour before your appointment
Do not wear any cosmetics or product to any of your visits (including test products)
Reminders for the study: DO NOT use any topical cleansers and skin treatment products (other than those assigned during the study) on your face. This includes, but is not limited to moisturizers, serums, cleansers and medicated creams. DO NOT introduce new cosmetics and personal care products for the duration of the study. Color cosmetics which you are using regularly at the time of study enrollment is allowed. Call IRSI immediately if you experience any signs of irritation or with any questions or concerns.
Robigaile, Study Coordinator: 914-937-6500 ext 132
Reception Desk (during visits): 914-937-6500 ext 111
THANK YOU FOR YOUR PARTICIPATION
IRSI, Inc. Protocol No. 3931OSM0415 Final Protocol Ver. 2.6 June 29, 2015
CONFIDENTIAL Appendix II
Appendix II
Subjective Questionnaire
CASE REPORT FORM
Subjective Questionnaire Immediate (T15m)
June 15, 2015
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials: IMMEDIATE:
Page 1 of 4 This CRF has been reviewed for completion prior to subject’s dismissal from study visit
Tech Initials:
Please rate the level of agreement to the statements 15 minutes after product (Catalyst AC-11 only) application using the rating scales provided below. Be sure to answer every question. 1. The product immediately reduced the capillary redness of my facial skin.
a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
2. The product immediately improved the laxity (droopiness) of my eyelid skin. a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
3. The product immediately improved the firmness of my facial skin. a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
Questionnaire continued on the next page
CASE REPORT FORM
Subjective Questionnaire Immediate (T15m)
June 15, 2015
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials: IMMEDIATE:
Page 2 of 4 This CRF has been reviewed for completion prior to subject’s dismissal from study visit
Tech Initials:
4. The product immediately improved the elasticity of my facial skin. a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
5. The product immediately lifted my facial skin and improved the appearance of sagging in my face a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
6. The product immediately tightened my facial skin a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
7. The product immediately improved the appearance of lines/wrinkles on my crow’s feet area. a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
Questionnaire continued on the next page
CASE REPORT FORM
Subjective Questionnaire Immediate (T15m)
June 15, 2015
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials: IMMEDIATE:
Page 3 of 4 This CRF has been reviewed for completion prior to subject’s dismissal from study visit
Tech Initials:
8. The product immediately reduced the appearance of lines/wrinkles on my facial skin.
a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
9. My facial skin appears less dull and more radiant immediately after using the product. a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
10. The product immediately improved the appearance of my facial skin, illuminating my complexion with a fresh youth infused glow. a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
11. The product immediately enhanced the overall appearance of my facial skin. a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
Questionnaire continued on the next page
CASE REPORT FORM
Subjective Questionnaire Immediate (T15m)
June 15, 2015
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials: IMMEDIATE:
Page 4 of 4 This CRF has been reviewed for completion prior to subject’s dismissal from study visit
Tech Initials:
12. I did not experience any irritation after product application a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
13. I immediately felt there was a relief in my actinic keratosis (scaly, crusty lesion) a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
f. Not Applicable – I do not have actinic keratosis
CASE REPORT FORM
Subjective Questionnaire Week 1
June 22, 2015
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials: WEEK 1
Page 1 of 4 This CRF has been reviewed for completion prior to subject’s dismissal from study visit
Tech Initials:
Please rate the level of agreement to the statements after one week of using the test products (regimen) using the rating scales provided below. Be sure to answer every question. 1. The regimen reduced the capillary redness of my facial skin.
a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
2. The regimen improved the laxity (droopiness) of my eyelid skin. a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
3. The regimen improved the firmness of my facial skin. a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
Questionnaire continued on the next page
CASE REPORT FORM
Subjective Questionnaire Week 1
June 22, 2015
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials: WEEK 1
Page 2 of 4 This CRF has been reviewed for completion prior to subject’s dismissal from study visit
Tech Initials:
4. The regimen improved the elasticity of my facial skin. a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
5. The regimen lifted my facial skin and improved the appearance of sagging in my face a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
6. The regimen tightened my facial skin a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
7. The regimen improved the appearance of lines/wrinkles on my crow’s feet area. a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
Questionnaire continued on the next page
CASE REPORT FORM
Subjective Questionnaire Week 1
June 22, 2015
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials: WEEK 1
Page 3 of 4 This CRF has been reviewed for completion prior to subject’s dismissal from study visit
Tech Initials:
8. The regimen reduced the appearance of lines/wrinkles on my facial skin.
a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
9. My facial skin appears less dull and more radiant after using the regimen. a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
10. The regimen improved the appearance of my facial skin, illuminating my complexion with a fresh youth infused glow. a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
11. The regimen enhanced the overall appearance of my facial skin. a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
Questionnaire continued on the next page
CASE REPORT FORM
Subjective Questionnaire Week 1
June 22, 2015
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials: WEEK 1
Page 4 of 4 This CRF has been reviewed for completion prior to subject’s dismissal from study visit
Tech Initials:
12. I did not experience any irritation after using the regimen for one week. a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
13. I felt there was a relief in my actinic keratosis (scaly, crusty lesion) after using the regimen for one week. a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
f. Not Applicable – I do not have actinic keratosis
CASE REPORT FORM
Subjective Questionnaire Week 4
July 13, 2015
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials: WEEK 4
Page 1 of 4 This CRF has been reviewed for completion prior to subject’s dismissal from study visit
Tech Initials:
Please rate the level of agreement to the statements after four week of using the test products (regimen) using the rating scales provided below. Be sure to answer every question. 1. The regimen reduced the capillary redness of my facial skin.
a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
2. The regimen improved the laxity (droopiness) of my eyelid skin. a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
3. The regimen improved the firmness of my facial skin. a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
Questionnaire continued on the next page
CASE REPORT FORM
Subjective Questionnaire Week 4
July 13, 2015
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials: WEEK 4
Page 2 of 4 This CRF has been reviewed for completion prior to subject’s dismissal from study visit
Tech Initials:
4. The regimen improved the elasticity of my facial skin. a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
5. The regimen lifted my facial skin and improved the appearance of sagging in my face a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
6. The regimen tightened my facial skin a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
7. The regimen improved the appearance of lines/wrinkles on my crow’s feet area. a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
Questionnaire continued on the next page
CASE REPORT FORM
Subjective Questionnaire Week 4
July 13, 2015
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials: WEEK 4
Page 3 of 4 This CRF has been reviewed for completion prior to subject’s dismissal from study visit
Tech Initials:
8. The regimen reduced the appearance of lines/wrinkles on my facial skin.
a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
9. My facial skin appears less dull and more radiant after using the regimen. a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
10. The regimen improved the appearance of my facial skin, illuminating my complexion with a fresh youth infused glow. a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
11. The regimen enhanced the overall appearance of my facial skin. a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
Questionnaire continued on the next page
CASE REPORT FORM
Subjective Questionnaire Week 4
July 13, 2015
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials: WEEK 4
Page 4 of 4 This CRF has been reviewed for completion prior to subject’s dismissal from study visit
Tech Initials:
12. I did not experience any irritation after using the regimen for four weeks. a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
13. I felt there was a relief in my actinic keratosis (scaly, crusty lesion) after using the regimen for four weeks. a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
f. Not Applicable – I do not have actinic keratosis
CASE REPORT FORM
Subjective Questionnaire Week 8
August 10, 2015
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials: WEEK 8
Page 1 of 4 This CRF has been reviewed for completion prior to subject’s dismissal from study visit
Tech Initials:
Please rate the level of agreement to the statements after eight weeks of using the test products (regimen) using the rating scales provided below. Be sure to answer every question. 1. The regimen reduced the capillary redness of my facial skin.
a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
2. The regimen improved the laxity (droopiness) of my eyelid skin. a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
3. The regimen improved the firmness of my facial skin. a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
Questionnaire continued on the next page
CASE REPORT FORM
Subjective Questionnaire Week 8
August 10, 2015
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials: WEEK 8
Page 2 of 4 This CRF has been reviewed for completion prior to subject’s dismissal from study visit
Tech Initials:
4. The regimen improved the elasticity of my facial skin. a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
5. The regimen lifted my facial skin and improved the appearance of sagging in my face a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
6. The regimen tightened my facial skin a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
7. The regimen improved the appearance of lines/wrinkles on my crow’s feet area. a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
Questionnaire continued on the next page
CASE REPORT FORM
Subjective Questionnaire Week 8
August 10, 2015
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials: WEEK 8
Page 3 of 4 This CRF has been reviewed for completion prior to subject’s dismissal from study visit
Tech Initials:
8. The regimen reduced the appearance of lines/wrinkles on my facial skin.
a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
9. My facial skin appears less dull and more radiant after using the regimen. a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
10. The regimen improved the appearance of my facial skin, illuminating my complexion with a fresh youth infused glow. a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
11. The regimen enhanced the overall appearance of my facial skin. a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
Questionnaire continued on the next page
CASE REPORT FORM
Subjective Questionnaire Week 8
August 10, 2015
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials: WEEK 8
Page 4 of 4 This CRF has been reviewed for completion prior to subject’s dismissal from study visit
Tech Initials:
12. I did not experience any irritation after using the regimen for eight weeks. a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
13. I felt there was a relief in my actinic keratosis (scaly, crusty lesion) after using the regimen for eight weeks. a. Strongly Agree
b. Agree
c. Neutral
d. Disagree
e. Strongly Disagree
f. Not Applicable – I do not have actinic keratosis
IRSI, Inc. Protocol No. 3931OSM0415 Final Protocol Ver. 2.6 June 29, 2015
CONFIDENTIAL Appendix III
Appendix III
Case Report Forms
CASE REPORT FORM
Tracking Form Screening/ Washout
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from study visit Tech Initials:
SCREENING: Page 1 of 4
TOTAL: Page 1 of 4
Subject Signature:
Screening/ Washout: June 8, 2015 Tech Time
Arrival at site
Subjects complete informed consent and model release and medical history
Inclusion / Exclusion criteria checked (NOT VAS – To be checked at BL)
Dispense washout products (Dove Beauty Bar – White and Dual Purpose Treatment Moisture with SPF 15) and washout instructions
All CRFs reviewed for completion
Subjects dismissed from visit
CASE REPORT FORM
Medical History Screening/ Washout
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from study visit Tech Initials:
SCREENING: Page 2 of 4
TOTAL: Page 2 of 4
Please fill out the following form completely, if you need assistance please speak with an IRSI Technician.
Name:
Last: First: MI:
Date: / /
Height:
Ft. In.
Weight
Lbs.
Date of Birth:
Mo. Day Year
Age: Sex: Male Female
Ethnicity: Hispanic or Latino Not Hispanic or Latino
Race: American Indian or Alaska Native Asian (circle one: Far East, Southeast Asia, Indian subcontinent) Black or African American Native Hawaiian or Other Pacific Islander White Other____________
Facial Skin Type: Normal Oily Dry Combination
Body Skin Type: Normal Dry Very Dry
Fitzpatrick Skin Type: (see examples)
Type I Type IV
Type II Type V
Type III Type VI
Do you have Sensitive Skin? YES NO
Do you have Sensitive Eyes?
YES NO
Do you wear contact lenses? YES NO
Occupation: Retired Homemaker Unemployed Employed, Job Title: 1. Do you have any of the
following: Yes No
2. Have you had a reaction to any of the following:
Yes No
Asthma or emphysema Fragrances and Perfumes
Hay Fever or seasonal allergies Creams
Food allergies Moisturizers
Eczema or Psoriasis Soaps
Thyroid Problems Other body products
High Cholesterol Cosmetics
Diabetes, if yes: Sunscreens
A .Insulin Dependent NA If “yes” any of the above, please explain below:
B. Non-Insulin Dependent NA
Eye disease or condition
High Blood Pressure
Are you pregnant, nursing a child or planning on becoming pregnant during this study? Yes No NA
3. What method of birth control are you currently using? Tubal Ligation NuvaRing Norplant
Hysterectomy Depo Provera Abstinence
Diaphragm Birth Control Pill Post-Menopausal
IUD Condom Other
List Medications taken within the past thirty (30) days. Please include prescription drugs, vitamins, skin treatments, herbal remedies, allergy medications, antihistamines, steroids, antibiotics, anti-inflammatory drugs, antacids, and contraceptives:
If no medications have been taken in the past thirty (30) days, check here
Medications
Name of Medication Dose Reason for taking Medication Date
Ongoing Start Stop
This form reflects all medical information up to the first day of this study. Notify our staff if there is any change in this information.
Inclusion / Exclusion Screening / Washout
Study Number 3931OSM0415
Subject Initials
Subject Number
This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials:
SCREENING: Page 3 of 4
This CRF has been reviewed for completion prior to subject’s dismissal from study visit Tech Initials:
TOTAL: Page 3 of 4
INCLUSION CRITERIA If any box is checked “No”, subject is NOT eligible to continue study. YES NO
1. Is the subject a female in good general health, and between ages 35 and 59 years old, inclusive at enrollment?
2.
Does the Subject have line and wrinkles and eyelid laxity as determined by an expert grader at Baseline visit:
a. Score of ≥2 on 10 cm VAS for lines and wrinkles (Crow’s Feet)? b. Score of ≥2 on 10 cm VAS for eyelid laxity?
*The response to this criteria is recorded on the Baseline CRF at the Baseline Visit
3.
A portion of the panel (approximately n=10) with capillary visibility (telangiectasia) Does the subject have:
a. Score of ≥2 on 10 cm VAS for capillary visibility *The response to this criteria is recorded on the Baseline CRF at the Baseline Visit
4.
A portion of the panel (approximately n=10) with actinic keratosis as determined by an expert grader at Baseline:
b. Score of ≥2 on 10 cm VAS for actinic keratosis severity *The response to this criteria is recorded on the Baseline CRF at the Baseline Visit
5. Is the subject willing to be photographed and to sign a photograph release form?
6. Is the Subject able to read, understand and willing to sign an ICF, including HIPAA and state requirements, complete a brief personal medical/history?
7.
Is the subject dependable and willing to attend study visits and comply with all study instructions and requirements, including but not limited to:
a. Willing to abstain from any other superficial or deep facial procedure during the study (dermabrasion, microdermabrasion, peels, photo facials, laser treatment, facial lesion removal, etc.)?
b. Willing to abstain from use of all other topical products for the duration of the washout period and study period?
c. Willing to abstain from the use of tanning bed use and recreational sun exposure on the face for the duration of the washout and study period?
EXCLUSION CRITERIA If any box is checked “Yes”, subject is NOT eligible to continue study. YES NO
1. Is the subject using systemic or topical steroids, Accutane, oral or topical estrogens, and/or other medicines affecting skin in a major way during study period or washout period?
2. Does the subject have present or previous inflammatory or other skin diseases, such as rosacea, severe acne, Systemic Lupus Erythematosus (SLE), dermatomyositis, scleroderma, etc.?
3. Is the subject currently smokers or are smokers within one month prior to enrollment?
4. Is the subject participating in any other clinical trials?
Exclusion Criteria continued on next page
Screening/ Washout: June 8, 2015 Tech
Inclusion / Exclusion criteria checklist
Inclusion / Exclusion Screening / Washout
Study Number 3931OSM0415
Subject Initials
Subject Number
This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials:
SCREENING: Page 4 of 4
This CRF has been reviewed for completion prior to subject’s dismissal from study visit Tech Initials:
TOTAL: Page 4 of 4
EXCLUSION CRITERIA - Continued
If any box is checked “Yes”, subject is NOT eligible to continue study. YES NO
5.
Does the subject have an acute or chronic disease or medical condition, including dermatological problems, which could put her at risk in the opinion of the Principal Investigator or compromise study outcomes? Typical uncontrolled chronic or serious disease and conditions which would prevent participation in any clinical trial are cancer, AIDS, diabetes, morbid obesity, renal impairment, mental illness, drug/alcohol addiction.
6. Is the subject unreliable or unlikely to be available for the duration of the study?
7. Does the subject have history of allergic reaction, skin sensitization and/or know allergies to cosmetic ingredients, toiletries, sunscreens, etc.?
7. Has the subject been using oral contraception for less than three months before the screening visit or who has changed her contraceptive method within the three months before the Baseline visit or planning to modify her contraception treatment within the duration of the study?
8. Is the subject immunocompromised?
9. Is the subject a woman who started Hormone Replacement Therapy within the last three months preceding the screening visit?
10. Is the subject a woman using oral contraception for less than three months before the screening visit or who has changed her contraception method within the three months before the Baseline Visit or planning to modify her contraception treatment within the duration of the study?
11. Is the subject known to be pregnant, lactating or planning to become pregnant within six months? Subjects who become pregnant during the study must inform the Principal Investigator immediately.
12. Is the subject unable to communicate or cooperate with the Principal Investigator due to language problems, poor mental development, or impaired cerebral function?
13. Is the subject an employee of IRSI or other testing firms/laboratories, cosmetic or raw goods manufacturers or suppliers?
Based on the above inclusion/ exclusion criteria, does the subject qualify?
CASE REPORT FORM
Tracking Form Baseline
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from the station Tech Initials:
BASELINE: Page 1 of 9
This CRF has been reviewed for completion prior to subject’s dismissal from study visit Tech Initials:
TOTAL: Page 1 of 31
ENROLLED SUBJECTS REMAIN ONSITE FOR IMMEDIATE ASSESSMENTS
Subject Signature:
Baseline: June 15, 2015 Tech Time
Arrive at site/15 minute acclimation period (face) Arrival Time:
Equil:
Compliance check (Inclusion / Exclusion) Subject Compliant?
Circle One
Yes No
Medical History review, questioned for AEs
AE Reported? Circle One
Yes No
Expert Grader Assessments (VAS) Also check inclusion criteria
No. of Assessments: TOTAL 8
Expert Grader Assessments (VAS )Also check inclusion criteria
Subject chosen for capillary visibility portion? N=10
Circle One
Yes No
Expert Grader Assessments (VAS )Also check inclusion criteria
Subject chosen for actinic keratosis portion? N=10
Circle One
Yes No
Subject status: Circle One
Enrolled Disqualified
Imaging: Clarity™ 2D Research Ti Imaging (F, L, R view)
Subject chosen for sub-group? N=5
Circle One
Yes No
Instrumental Evaluation: Cosmetrics
Instrumental Evaluation: Cutometer
Dispense products, diary, verbal and written use instructions
In clinic product application under supervision
All CRFs reviewed for completion
CASE REPORT FORM
Medical History and AEs Baseline
Study Number 3906LP0115
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials:
Baseline: Page 2 of 9
This CRF has been reviewed for completion prior to subject’s dismissal from study visit Tech Initials:
TOTAL: Page 2 of 31
Baseline: June 15, 2015 Tech
Medical history and AEs
List any changes to medical history mentioned by the Subject, including but not limited to medications taken:
Any AEs or SAEs to report?
Circle One
Yes* No
*If yes, fill out AE form
Compliance Baseline
Study Number 3931OSM0415
Subject Initials
Subject Number
This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials:
Baseline: Page 3 of 9
This CRF has been reviewed for completion prior to subject’s dismissal from study visit Tech Initials:
TOTAL: Page 3 of 31
Compliance If any box is checked “No”, subject is NOT eligible to continue study. YES NO
1. Subject has arrived for Baseline visit having cleansed face within 1 hour prior to study visit?
2. Subject has used the support products as instructed?
3. Subject has not used any topical cleansers and skin treatment products (other than those assigned during the stud) on the face? This includes, but is not limited to moisturizers, serums, cleansers and medicated creams.
Applicable INCLUSION CRITERIA
If any box is checked “No”, subject is NOT eligible to continue study. YES NO
1.
Does the subject have lines and wrinkles and eyelid laxity as determined by an expert grader at Baseline?
a. Score of ≥ 2 cm on 10 cm VAS for lines/wrinkles (crow’s feet)? b. Score of ≥2 cm on 10 cm VAS for eyelid laxity?
2.
A portion of the panel (approximately n=10) with Capillary visibility (telangiectasia)
a. Score of ≥ 2 cm on 10 cm VAS for capillary visibility?
3.
A portion of the panel (approximately n=10) with actinic keratosis as determined by an expert grader at Baseline:
b. Score of ≥ 2 cm on 10 cm VAS for actinic keratosis visibility?
Applicable EXCLUSION CRITERIA
If any box is checked “Yes”, subject is NOT eligible to continue study. YES NO
1.
Has the subject been using oral contraception for less than three months before the screening visit or who has changed her contraceptive method within the three months before the Baseline visit or planning to modify her contraception treatment within the duration of the study?
Based on the above compliance questions and applicable inclusion/ exclusion criteria, does the subject qualify to continue?
Baseline: June 15, 2015 Tech
Compliance (Applicable Inclusion / Exclusion) checklist
Expert Visual Grading Baseline
Study Number 3931OSM0415
Subject Initials
Subject Number
This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials:
BASELINE: Page 4 of 9
This CRF has been reviewed for completion prior to subject’s dismissal from study visit Tech Initials:
TOTAL: Page 4 of 31
Texture/Smoothness - Visual
SCORE:
0 cm
10 cm
Smooth, refined even surface appearance
Rough, uneven
surface appearance
Fine Lines/Wrinkles (crow’s feet)
SCORE:
0 cm 10 cm None Must have score of ≥2 cm to qualify
Qualifies___ Does not Qualify___
Numerous, lines/Wrinkles –
Severe, Deep
Radiance/Luminosity
SCORE:
0 cm
10 cm
Radiant, Luminous Dull/Matte
Appearance And/or Sallow
Eyelid Laxity
SCORE:
0 cm Taut
“Awake”
Must have score of ≥2 cm to qualify Qualifies___ Does not Qualify___
10 cm Sagging “Tired”
Smooth Eyelid Drooping Eyelid
Elasticity (tactile)
SCORE:
0 cm Good stretch
10 cm Poor Stretch
And Bounce back And Bounce back
Baseline: June 15, 2015 Tech
VAS FACE No. of Assessments: 9
Expert Visual Grading Baseline
Study Number 3931OSM0415
Subject Initials
Subject Number
This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials:
BASELINE: Page 5 of 9
This CRF has been reviewed for completion prior to subject’s dismissal from study visit Tech Initials:
TOTAL: Page 5 of 31
Overall Appearance
SCORE:
0 cm
Vibrant Healthy Appearance
10 cm Aged, Unhealthy
Appearance
Capillary Visibility*
SCORE:
0 cm None
□ – NA * Only grade if subject presents this at Baseline
(portion of Panel)
10 cm Highly visible,
intense red capillary
Actinic Keratosis Severity*
0 cm 10 cm
SCORE:
Radiant, None
□– NA * Only grade if subject presents this at Baseline
(portion of Panel)
Highly visible patches
Photography Clarity 2D
Study Number 3931OSM0415
Subject Initials
Subject Number
This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials:
BASELINE: Page 6 of 9
This CRF has been reviewed for completion prior to subject’s dismissal from study visit Tech Initials:
TOTAL: Page 6 of 31
SUBJECT SELECTED FOR CLARITY SUBGROUP? YES NO ALL THREE IMAGING POSITIONS WILL BE TAKEN AT ALL TIMEPOINTS (RIGHT/FRONT/LEFT) Baseline/June 15, 2015
1. Subject has no makeup residue on face? ___Yes ___No
2. Subject’s headband and cape is properly placed? ___Yes ___No
CLARITY 2D RESEARCH TI IMAGING Tech
Measurement of table height _______ inches
Forehead rest position
Chin rest position
Images reviewed prior to subject leaving Clarity Station to include quality of
image, position and facial expression
*Images should be taken with eyes closed
Week 1/June 22, 2015 1. Subject has no makeup residue on face? ___Yes ___No
2. Subject’s headband and cape is properly placed? ___Yes ___No
CLARITY 2D RESEARCH TI IMAGING Tech
Measurement of table height _______ inches
Forehead rest position
Chin rest position
Images reviewed prior to subject leaving Clarity Station to include quality of
image, position and facial expression (as compared to Baseline Images)
*Images should be taken with eyes closed
Photography Clarity 2D
Study Number 3931OSM0415
Subject Initials
Subject Number
This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials:
BASELINE: Page 7 of 9
This CRF has been reviewed for completion prior to subject’s dismissal from study visit Tech Initials:
TOTAL: Page 7 of 31
Week 4/ July 13, 2015 1. Subject has no makeup residue on face? ___Yes ___No
2. Subject’s headband and cape is properly placed? ___Yes ___No
CLARITY 2D RESEARCH TI IMAGING Tech
Measurement of table height _______ inches
Forehead rest position
Chin rest position
Images reviewed prior to subject leaving Clarity Station to include quality of
image, position and facial expression (as compared to Baseline Images)
*Images should be taken with eyes closed
Week 8/ August 10, 2015 1. Subject has no makeup residue on face? ___Yes ___No
2. Subject’s headband and cape is properly placed? ___Yes ___No
CLARITY 2D RESEARCH TI IMAGING Tech
Measurement of table height _______ inches
Forehead rest position
Chin rest position
Images reviewed prior to subject leaving Clarity Station to include quality of
image, position and facial expression (as compared to Baseline Images)
*Images should be taken with eyes closed
Face Map
Study Number 3931OSM0415
Subject Initials
Subject Number
This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials:
BASELINE: Page 8 of 9
This CRF has been reviewed for completion prior to subject’s dismissal from study visit Tech Initials:
TOTAL: Page 8 of 31
Instructions: Using a ruler, identify the location where measurement will be taken. When possible at least two anatomical locations should be used to indicate the measurement location. The type of measurement should be clearly indicated
Marker Tech Evaluation
* Cosmetrics
+ Cutometer
Instrumental Evaluation Baseline
Study Number 3931OSM0415
Subject Initials
Subject Number
This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials:
BASELINE: Page 9 of 9
This CRF has been reviewed for completion prior to subject’s dismissal from study visit Tech Initials:
TOTAL: Page 9 of 31
Baseline: June 15, 2015 Tech Cutometer Duplicate measurement on cheek.
Test Site Location LEFT or RIGHT Cheek
Circle One Wiping Performed: ☐ YES ☐ NO
Randomized YES Template Attached: Face Map
Cutometer measurements recorded using EDC.
Baseline: June 15, 2015 Tech Cosmetrics SIAscope Duplicate measurements on a designated site Note: Take measurement on the cheek where red capillaries are visible if applicable. For subjects without visible capillaries, take the measurement on the cheek of choice and mark on the face map.
Test Site Location LEFT or RIGHT Cheek
Circle One Wiping Performed: ☐ YES ☐ NO
Randomized NO Template Attached: Face Map
Hemoglobin
Cheek Measurement 1
Mean: Std. Dev:
Hemoglobin
Cheek Measurement 2
Mean: Std. Dev:
Tracking Form Immediate Post Application
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from the station Tech Initials:
IMMEDIATE: Page 1 of 4
This CRF has been reviewed for completion prior to subject’s dismissal from study visit Tech Initials:
TOTAL: Page 10 of 31
Immediate Post Application (T15M): June 15, 2015 Tech Time
Expert Grader Assessments (VAS) No. of Assessments: TOTAL 8
Expert Grader Assessments (VAS) Subject chosen for capillary visibility portion? N=10
Circle One
Yes No
Expert Grader Assessments (VAS) Subject chosen for actinic keratosis portion? N=10
Circle One
Yes No
Instrumental: Cutometer
Subjective Questionnaire
All CRFs and questionnaires reviewed for completion
Subject dismissed from test site, subject reminded of Week 1 visit
Expert Visual Grading Immediate Post Application
Study Number 3931OSM0415
Subject Initials
Subject Number
This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials:
Immediate: Page 2 of 4
This CRF has been reviewed for completion prior to subject’s dismissal from study visit Tech Initials:
TOTAL: Page 11 of 31
Texture/Smoothness - Visual
SCORE:
0 cm
10 cm
Smooth, refined even surface appearance
Rough, uneven
surface appearance
Fine Lines/Wrinkles (crow’s feet)
SCORE:
0 cm 10 cm None Numerous,
lines/Wrinkles –Severe, Deep
Radiance/Luminosity
SCORE:
0 cm
10 cm
Radiant, Luminous Dull/Matte
Appearance And/or Sallow
Eyelid Laxity
SCORE:
0 cm Taut
“Awake”
10 cm Sagging “Tired”
Smooth Eyelid Drooping Eyelid
Elasticity (tactile)
SCORE:
0 cm Good stretch
10 cm Poor Stretch
And Bounce back And Bounce back
Immediate (T15M): June 15, 2015 Tech
VAS FACE No. of Assessments: 9
Expert Visual Grading Immediate Post Application
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from study visit Tech Initials:
IMMEDIATE: Page 3 of 4
TOTAL: Page 12 of 31
Overall Appearance
SCORE:
0 cm
Vibrant Healthy Appearance
10 cm Aged, Unhealthy
Appearance
Capillary Visibility*
SCORE:
0 cm None
□ – NA * Only grade if subject presents this at Baseline
(portion of Panel)
10 cm Highly visible,
intense red capillary
Actinic Keratosis Severity*
0 cm 10 cm
SCORE:
Radiant, None
□ – NA * Only grade if subject presents this at Baseline
(portion of Panel)
Highly visible patches
Instrumental Evaluation Immediate Post Application
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from study visit Tech Initials:
IMMEDIATE: Page 4 of 4
TOTAL: Page 13 of 31
Immediate (T15M): June 15, 2015 Tech Cutometer Duplicate measurements on cheek.
Test Site Location LEFT or RIGHT Cheek
Circle One Wiping Performed: ☐ YES ☐ NO
Randomized YES Template Attached: Face Map
Cutometer measurements recorded using EDC.
Tracking Form Week 1
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from study visit Tech Initials:
WEEK 1: Page 1 of 6
TOTAL: Page 14 of 31
Subject Signature:
Week 1: June 22, 2015 Tech Time
Arrive at site/15 minute acclimation period (face)
Arrival Time:
Equil:
Complete and Review Subjective Questionnaire
Compliance check (Inclusion / Exclusion) Review diary/Inspect test products
Subject Compliant?
Circle One
Yes No
Medical History review, questioned for AEs
AE Reported? Circle One
Yes No
Expert Grader Assessments (VAS) No. of Assessments: TOTAL 8
Expert Grader Assessments
Subject chosen for capillary visibility portion? N=10
Circle One
Yes No
Expert Grader Assessments
Subject chosen for actinic keratosis portion? N=10
Circle One
Yes No
Imaging: Clarity™ 2D Research Ti Imaging (F, L, R view)
Subject chosen for sub-group? N=5
Circle One
Yes No
Instrumental Evaluation: Cosmetrics
Instrumental Evaluation: Cutometer
All CRFs reviewed for completion
CASE REPORT FORM
Medical History and AEs Week 1
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials:
WEEK 1: Page 2 of 6
This CRF has been reviewed for completion prior to subject’s dismissal from study visit Tech Initials:
TOTAL: Page 15 of 31
Week 1: June 22, 2105 Tech
Medical history and AEs
List any changes to medical history mentioned by the Subject, including but not limited to medications taken:
Any AEs or SAEs to report?
Circle One
Yes* No
*If yes, fill out AE form
CASE REPORT FORM
Compliance Week 1
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials:
WEEK 1: Page 3 of 6
This CRF has been reviewed for completion prior to subject’s dismissal from study visit Tech Initials:
TOTAL: Page 16 of 31
Compliance If any box is checked “No”, subject is NOT eligible to continue study. YES NO
1. Subject has arrived for Week 1 Visit having cleansed face within 1 hour prior to study visit?
2. Subject has used the support and test products as instructed?
3. Subject has not used any topical cleansers and skin treatment products (other than those assigned during the stud) on the face? This includes, but is not limited to moisturizers, serums, cleansers and medicated creams.
Based on the above compliance questions and applicable inclusion/ exclusion criteria, does the subject qualify to continue?
Week 1: June 22, 2015 Tech
Compliance (Applicable Inclusion / Exclusion) checklist
CASE REPORT FORM
Expert Visual Grading Week 1
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from the station Tech Initials:
Week 1: Page 4 of 6
This CRF has been reviewed for completion prior to subject’s dismissal from study visit Tech Initials:
TOTAL: Page 17 of 31
Texture/Smoothness - Visual
SCORE:
0 cm
10 cm
Smooth, refined even surface appearance
Rough, uneven
surface appearance
Fine Lines/Wrinkles (crow’s feet)
SCORE:
0 cm 10 cm None Numerous,
lines/Wrinkles –Severe, Deep
Radiance/Luminosity
SCORE:
0 cm
10 cm
Radiant, Luminous Dull/Matte
Appearance And/or Sallow
Eyelid Laxity
SCORE:
0 cm Taut
“Awake”
10 cm Sagging “Tired”
Smooth Eyelid Drooping Eyelid
Elasticity (tactile)
SCORE:
0 cm Good stretch
10 cm Poor Stretch
And Bounce back And Bounce back
Week 1: June 22, 2015 Tech
VAS- FACE No. of Assessments: 8
CASE REPORT FORM
Expert Visual Grading Week 1
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from the station Tech Initials:
Week 1: Page 5 of 6
This CRF has been reviewed for completion prior to subject’s dismissal from study visit Tech Initials:
TOTAL: Page 18 of 31
Overall Appearance
SCORE:
0 cm
Vibrant Healthy Appearance
10 cm Aged, Unhealthy
Appearance
Capillary Visibility*
SCORE:
0 cm None
□ – NA * Only grade if subject presents this at Baseline
(portion of Panel)
10 cm Highly visible,
intense red capillary
Actinic Keratosis Severity*
0 cm 10 cm
SCORE:
Radiant, None
□ – NA * Only grade if subject presents this at Baseline
(portion of Panel)
Highly visible patches
Instrumental Evaluations Week 1
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from the station Tech Initials:
WEEK 1 : Page 6 of 6
This CRF has been reviewed for completion prior to subject’s dismissal from study visit Tech Initials:
TOTAL: Page 19 of 31
Week 1: June 22, 2015 Tech Cutometer Duplicate measurements on cheek.
Test Site Location LEFT or RIGHT Cheek
Circle One Wiping Performed: ☐ YES ☐ NO
Randomized YES Template Attached: Face Map
Cutometer measurements recorded using EDC.
Week 1: June 22, 2015 Tech Cosmetrics SIAscope Duplicate measurements on a designated site Note: Take measurement on the cheek where red capillaries are visible if applicable. For subjects without visible capillaries, take the measurement on the cheek of choice and mark on the face map.
Test Site Location LEFT or RIGHT Cheek
Circle One Wiping Performed: ☐ YES ☐ NO
Randomized NO Template Attached: Face Map
Hemoglobin
Cheek Measurement 1
Mean: Std. Dev:
Hemoglobin
Cheek Measurement 2
Mean: Std. Dev:
Tracking Form Week 4
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from the station Tech Initials:
WEEK 4 : Page 1 of 6
This CRF has been reviewed for completion prior to subject’s dismissal from study visit Tech Initials:
TOTAL: Page 20 of 31
Subject Signature:
Week 4: July 13, 2015 Tech Time
Arrive at site/15 minute acclimation period (face) Arrival Time:
Equil:
Complete and Review Subjective Questionnaire
Compliance check (Inclusion / Exclusion) Review diary/Inspect test products
Subject Compliant?
Circle One
Yes No
Medical History review, questioned for AEs
AE Reported? Circle One
Yes No
Expert Grader Assessments (VAS) No. of Assessments: TOTAL 8
Expert Grader Assessments
Subject chosen for capillary visibility portion? N=10
Circle One
Yes No
Expert Grader Assessments
Subject chosen for actinic keratosis portion? N=10
Circle One
Yes No
Imaging: Clarity™ 2D Research Ti Imaging (F, L, R view)
Subject chosen for sub-group? N=5
Circle One
Yes No
Instrumental Evaluation: Cosmetrics
Instrumental Evaluation: Cutometer
All CRFs reviewed for completion
CASE REPORT FORM
Medical History and AEs Week 4
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials:
WEEK 4: Page 2 of 6
This CRF has been reviewed for completion prior to subject’s dismissal from study visit Tech Initials:
TOTAL: Page 21 of 31
Week 4: July 13, 2015 Tech
Medical history and AEs
List any changes to medical history mentioned by the Subject, including but not limited to medications taken:
Any AEs or SAEs to report?
Circle One
Yes* No
*If yes, fill out AE form
CASE REPORT FORM
Compliance Week 4
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials:
WEEK 4: Page 3 of 6
This CRF has been reviewed for completion prior to subject’s dismissal from study visit Tech Initials:
TOTAL: Page 22 of 31
Compliance If any box is checked “No”, subject is NOT eligible to continue study. YES NO
1. Subject has arrived for Week 4 Visit having cleansed face within 1 hour prior to study visit?
2. Subject has used the support and test products as instructed?
3. Subject has not used any topical cleansers and skin treatment products (other than those assigned during the stud) on the face? This includes, but is not limited to moisturizers, serums, cleansers and medicated creams.
Based on the above compliance questions and applicable inclusion/ exclusion criteria, does the subject qualify to continue?
Week 4: July 13, 2015 Tech
Compliance (Applicable Inclusion / Exclusion) checklist
CASE REPORT FORM
Expert Visual Grading Week 4
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from the station Tech Initials:
Week 4: Page 4 of 6
This CRF has been reviewed for completion prior to subject’s dismissal from study visit Tech Initials:
TOTAL: Page 23 of 31
Texture/Smoothness - Visual
SCORE:
0 cm
10 cm
Smooth, refined even surface appearance
Rough, uneven
surface appearance
Fine Lines/Wrinkles (crow’s feet)
SCORE:
0 cm 10 cm None Numerous,
lines/Wrinkles –Severe, Deep
Radiance/Luminosity
SCORE:
0 cm
10 cm
Radiant, Luminous Dull/Matte
Appearance And/or Sallow
Eyelid Laxity
SCORE:
0 cm Taut
“Awake”
10 cm Sagging “Tired”
Smooth Eyelid Drooping Eyelid
Elasticity (tactile)
SCORE:
0 cm Good stretch
10 cm Poor Stretch
And Bounce back And Bounce back
Week 4: July 13, 2015 Tech
VAS- FACE No. of Assessments: 8
CASE REPORT FORM
Expert Visual Grading Week 4
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from the station Tech Initials:
Week 4: Page 5 of 6
This CRF has been reviewed for completion prior to subject’s dismissal from study visit Tech Initials:
TOTAL: Page 24 of 31
Overall Appearance
SCORE:
0 cm
Vibrant Healthy Appearance
10 cm Aged, Unhealthy
Appearance
Capillary Visibility*
SCORE:
0 cm None
□ – NA * Only grade if subject presents this at Baseline
(portion of Panel)
10 cm Highly visible,
intense red capillary
Actinic Keratosis Severity*
0 cm 10 cm
SCORE:
Radiant, None
□ – NA * Only grade if subject presents this at Baseline
(portion of Panel)
Highly visible patches
Instrumental Evaluation Week 4
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from study visit Tech Initials:
WEEK 4: Page 6 of 6
TOTAL: Page 25 of 31
Week 4: July 13, 2015 Tech Cutometer Duplicate measurements on cheek.
Test Site Location LEFT or RIGHT Cheek
Circle One Wiping Performed: ☐ YES ☐ NO
Randomized YES Template Attached: Face Map
Cutometer measurements recorded using EDC.
Week 4: July 13, 2015 Tech Cosmetrics SIAscope Duplicate measurements on a designated site Note: Take measurement on the cheek where red capillaries are visible if applicable. For subjects without visible capillaries, take the measurement on the cheek of choice and mark on the face map.
Test Site Location LEFT or RIGHT Cheek
Circle One Wiping Performed: ☐ YES ☐ NO
Randomized NO Template Attached: Face Map
Hemoglobin
Cheek Measurement 1
Mean: Std. Dev:
Hemoglobin
Cheek Measurement 2
Mean: Std. Dev:
Tracking Form Week 8
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from study visit Tech Initials:
WEEK 8: Page 1 of 6
TOTAL: Page 26 of 31
Subject Signature:
Week 8: August 10, 2015 Tech Time
Arrive at site/15 minute acclimation period (face) Arrival Time:
Equil:
Complete and Review Subjective Questionnaire
Compliance check (Inclusion / Exclusion) Review diary/Inspect test products
Subject Compliant?
Circle One
Yes No
Medical History review, questioned for AEs
AE Reported? Circle One
Yes No
Expert Grader Assessments (VAS) No. of Assessments: TOTAL 8
Expert Grader Assessments
Subject chosen for capillary visibility portion? N=10
Circle One
Yes No
Expert Grader Assessments
Subject chosen for actinic keratosis portion? N=10
Circle One
Yes No
Imaging: Clarity™ 2D Research Ti Imaging (F, L, R view)
Subject chosen for sub-group? N=5
Circle One
Yes No
Instrumental Evaluation: Cosmetrics
Instrumental Evaluation: Cutometer
All CRFs reviewed for completion
CASE REPORT FORM
Medical History and AEs Week 8
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials:
WEEK 8: Page 2 of 6
This CRF has been reviewed for completion prior to subject’s dismissal from study visit Tech Initials:
TOTAL: Page 27 of 31
Week 8: August 10, 2015 Tech
Medical history and AEs
List any changes to medical history mentioned by the Subject, including but not limited to medications taken:
Any AEs or SAEs to report?
Circle One
Yes* No
*If yes, fill out AE form
CASE REPORT FORM
Compliance Week 8
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials:
WEEK 8: Page 3 of 6
This CRF has been reviewed for completion prior to subject’s dismissal from study visit Tech Initials:
TOTAL: Page 28 of 31
Compliance If any box is checked “No”, subject is NOT eligible to continue study. YES NO
1. Subject has arrived for Week 8 Visit having cleansed face within 1 hour prior to study visit?
2. Subject has used the support and test products as instructed?
3. Subject has not used any topical cleansers and skin treatment products (other than those assigned during the stud) on the face? This includes, but is not limited to moisturizers, serums, cleansers and medicated creams.
Based on the above compliance questions and applicable inclusion/ exclusion criteria, does the subject qualify to continue?
Week 8: August 10, 2015 Tech
Compliance (Applicable Inclusion / Exclusion) checklist
CASE REPORT FORM
Expert Visual Grading Week 8
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from the station Tech Initials:
Week 8: Page 4 of 6
This CRF has been reviewed for completion prior to subject’s dismissal from study visit Tech Initials:
TOTAL: Page 29 of 31
Texture/Smoothness - Visual
SCORE:
0 cm
10 cm
Smooth, refined even surface appearance
Rough, uneven
surface appearance
Fine Lines/Wrinkles (crow’s feet)
SCORE:
0 cm 10 cm None Numerous,
lines/Wrinkles –Severe, Deep
Radiance/Luminosity
SCORE:
0 cm
10 cm
Radiant, Luminous Dull/Matte
Appearance And/or Sallow
Eyelid Laxity
SCORE:
0 cm Taut
“Awake”
10 cm Sagging “Tired”
Smooth Eyelid Drooping Eyelid
Elasticity (tactile)
SCORE:
0 cm Good stretch
10 cm Poor Stretch
And Bounce back And Bounce back
Week 8: August 10, 2015 Tech
VAS- FACE No. of Assessments: 6
CASE REPORT FORM
Expert Visual Grading Week 8
Study Number 3931OSM0415
Subject Initials
Subject Number
Do not write below this line, for IRSI staff use only.
This CRF has been reviewed for completion prior to subject’s dismissal from the station Tech Initials:
Week 8: Page 5 of 6
This CRF has been reviewed for completion prior to subject’s dismissal from study visit Tech Initials:
TOTAL: Page 30 of 31
Overall Appearance
SCORE:
0 cm
Vibrant Healthy Appearance
10 cm Aged, Unhealthy
Appearance
Capillary Visibility*
SCORE:
0 cm None
□ – NA * Only grade if subject presents this at Baseline
(portion of Panel)
10 cm Highly visible,
intense red capillary
Actinic Keratosis Severity*
0 cm 10 cm
SCORE:
Radiant, None
□ – NA * Only grade if subject presents this at Baseline
(portion of Panel)
Highly visible patches
CASE REPORT FORM
Instrumental Evaluations Week 8
Study Number 3931OSM0415
Subject Initials
Subject Number
This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials:
WEEK 8: Page 6 of 6
This CRF has been reviewed for completion prior to subject’s dismissal from study visit Tech Initials:
TOTAL: Page 31 of 31
Week 8: August 10, 2015 Tech Cutometer Duplicate measurements on cheek.
Test Site Location LEFT or RIGHT Cheek
Circle One Wiping Performed: ☐ YES ☐ NO
Randomized YES Template Attached: Face Map
Cutometer measurements recorded using EDC.
Week 8: August 10, 2015 Tech Cosmetrics SIAscope Duplicate measurements on a designated site Note: Take measurement on the cheek where red capillaries are visible if applicable. For subjects without visible capillaries, take the measurement on the cheek of choice and mark on the face map.
Test Site Location LEFT or RIGHT Cheek
Circle One Wiping Performed: ☐ YES ☐ NO
Randomized NO Template Attached: Face Map
Hemoglobin
Cheek Measurement 1
Mean: Std. Dev:
Hemoglobin
Cheek Measurement 2
Mean: Std. Dev:
Temperature and Humidity Log
FORM Number: 035 Version: Implementation Date: Theoretical Withdraw Date:
1.0 11/6/2013 11/6/2015
This CRF has been reviewed for completion prior to completion of the study visit Tech Initials _______
Page 1 of 17
Instructions: Indoor temperature and humidity will be recorded every hour for studies involving temperature/humidity sensitive evaluations. For all studies, outdoor temperature and humidity conditions will be recorded each day and indoor temperature and humidity will be recorded at three time intervals, prior to first subject arrival/acclimation, halfway through the study visit, and upon completion of the study visit. A temperature and humidity log should be used for each room used in the study.
Study Number 3931OSM0415
VISIT BASELINE/T15M JUNE 15, 2015
OUTDOOR CONDITIONS
TEMPERATURE (°F) HUMIDITY (%RH)
High: High:
Low: Low:
Average: Average:
Source:
INDOOR CONDITIONS
ROOM:
RECEPTION AREA
DEVICE NUMBER:
TIME TEMPERATURE (°F) HUMIDITY (%RH) TECHNICIAN
INITIALS
Temperature and Humidity Log
FORM Number: 035 Version: Implementation Date: Theoretical Withdraw Date:
1.0 11/6/2013 11/6/2015
This CRF has been reviewed for completion prior to completion of the study visit Tech Initials _______
Page 2 of 17
Study Number 3931OSM0415
VISIT BASELINE/T15M JUNE 15, 2015
INDOOR CONDITIONS
ROOM: TREATMENT 1
(VISUALS) DEVICE
NUMBER:
TIME TEMPERATURE (°F) HUMIDITY (%RH) TECHNICIAN
INITIALS
Temperature and Humidity Log
FORM Number: 035 Version: Implementation Date: Theoretical Withdraw Date:
1.0 11/6/2013 11/6/2015
This CRF has been reviewed for completion prior to completion of the study visit Tech Initials _______
Page 3 of 17
Study Number 3931OSM0415
VISIT BASELINE/T15M JUNE 15, 2015
INDOOR CONDITIONS
ROOM: TREATMENT 2
(CUTOMETER/COSMETRICS) DEVICE
NUMBER:
TIME TEMPERATURE (°F) HUMIDITY
(%RH) TECHNICIAN
INITIALS
Temperature and Humidity Log
FORM Number: 035 Version: Implementation Date: Theoretical Withdraw Date:
1.0 11/6/2013 11/6/2015
This CRF has been reviewed for completion prior to completion of the study visit Tech Initials _______
Page 4 of 17
Study Number 3931OSM0415
VISIT BASELINE/T15M JUNE 15, 2015
ROOM: TREATMENT 3
(IMAGING) DEVICE
NUMBER:
TIME TEMPERATURE (°F) HUMIDITY (%RH) TECHNICIAN INITIALS
Temperature and Humidity Log
FORM Number: 035 Version: Implementation Date: Theoretical Withdraw Date:
1.0 11/6/2013 11/6/2015
This CRF has been reviewed for completion prior to completion of the study visit Tech Initials _______
Page 5 of 17
Study Number 3931OSM0415
VISIT BASELINE/T15M JUNE 15, 2015
ROOM: TREATMENT 4
(PRODUCT) DEVICE
NUMBER:
TIME TEMPERATURE (°F) HUMIDITY (%RH) TECHNICIAN INITIALS
Temperature and Humidity Log
FORM Number: 035 Version: Implementation Date: Theoretical Withdraw Date:
1.0 11/6/2013 11/6/2015
This CRF has been reviewed for completion prior to completion of the study visit Tech Initials _______
Page 6 of 17
Instructions: Indoor temperature and humidity will be recorded every hour for studies involving temperature/humidity sensitive evaluations. For all studies, outdoor temperature and humidity conditions will be recorded each day and indoor temperature and humidity will be recorded at three time intervals, prior to first subject arrival/acclimation, halfway through the study visit, and upon completion of the study visit. A temperature and humidity log should be used for each room used in the study.
Study Number 3931OSM0415
VISIT WEEK 1 JUNE 22, 2015
OUTDOOR CONDITIONS
TEMPERATURE (°F) HUMIDITY (%RH)
High: High:
Low: Low:
Average: Average:
Source:
INDOOR CONDITIONS
ROOM:
RECEPTION AREA
DEVICE NUMBER:
TIME TEMPERATURE (°F) HUMIDITY (%RH) TECHNICIAN
INITIALS
Temperature and Humidity Log
FORM Number: 035 Version: Implementation Date: Theoretical Withdraw Date:
1.0 11/6/2013 11/6/2015
This CRF has been reviewed for completion prior to completion of the study visit Tech Initials _______
Page 7 of 17
Study Number 3931OSM0415
VISIT WEEK 1 JUNE 22, 2015
INDOOR CONDITIONS
ROOM: TREATMENT 1
(VISUALS) DEVICE
NUMBER:
TIME TEMPERATURE (°F) HUMIDITY
(%RH) TECHNICIAN
INITIALS
Temperature and Humidity Log
FORM Number: 035 Version: Implementation Date: Theoretical Withdraw Date:
1.0 11/6/2013 11/6/2015
This CRF has been reviewed for completion prior to completion of the study visit Tech Initials _______
Page 8 of 17
Study Number 3931OSM0415
VISIT WEEK 1 JUNE 22, 2015
ROOM: TREATMENT 2
(CUTOMETER/COSMETRICS) DEVICE
NUMBER:
TIME TEMPERATURE (°F) HUMIDITY (%RH) TECHNICIAN INITIALS
Temperature and Humidity Log
FORM Number: 035 Version: Implementation Date: Theoretical Withdraw Date:
1.0 11/6/2013 11/6/2015
This CRF has been reviewed for completion prior to completion of the study visit Tech Initials _______
Page 9 of 17
Study Number 3931OSM0415
VISIT WEEK 1 JUNE 22, 2015
ROOM: TREATMENT 3
(IMAGING) DEVICE
NUMBER:
TIME TEMPERATURE (°F) HUMIDITY (%RH) TECHNICIAN INITIALS
Temperature and Humidity Log
FORM Number: 035 Version: Implementation Date: Theoretical Withdraw Date:
1.0 11/6/2013 11/6/2015
This CRF has been reviewed for completion prior to completion of the study visit Tech Initials _______
Page 10 of 17
Instructions: Indoor temperature and humidity will be recorded every hour for studies involving temperature/humidity sensitive evaluations. For all studies, outdoor temperature and humidity conditions will be recorded each day and indoor temperature and humidity will be recorded at three time intervals, prior to first subject arrival/acclimation, halfway through the study visit, and upon completion of the study visit. A temperature and humidity log should be used for each room used in the study.
Study Number 3931OSM0415
VISIT WEEK 4 JULY 13, 2015
OUTDOOR CONDITIONS
TEMPERATURE (°F) HUMIDITY (%RH)
High: High:
Low: Low:
Average: Average:
Source:
INDOOR CONDITIONS
ROOM:
RECEPTION AREA
DEVICE NUMBER:
TIME TEMPERATURE (°F) HUMIDITY (%RH) TECHNICIAN
INITIALS
Temperature and Humidity Log
FORM Number: 035 Version: Implementation Date: Theoretical Withdraw Date:
1.0 11/6/2013 11/6/2015
This CRF has been reviewed for completion prior to completion of the study visit Tech Initials _______
Page 11 of 17
Study Number 3931OSM0415
VISIT WEEK 4 JULY 13, 2015
INDOOR CONDITIONS
ROOM: TREATMENT 1
(VISUALS) DEVICE
NUMBER:
TIME TEMPERATURE (°F) HUMIDITY
(%RH) TECHNICIAN
INITIALS
Temperature and Humidity Log
FORM Number: 035 Version: Implementation Date: Theoretical Withdraw Date:
1.0 11/6/2013 11/6/2015
This CRF has been reviewed for completion prior to completion of the study visit Tech Initials _______
Page 12 of 17
Study Number 3931OSM0415
VISIT WEEK 4 JULY 13, 2015
ROOM: TREATMENT 2
(CUTOMETER/COSMETRICS) DEVICE
NUMBER:
TIME TEMPERATURE (°F) HUMIDITY (%RH) TECHNICIAN INITIALS
Temperature and Humidity Log
FORM Number: 035 Version: Implementation Date: Theoretical Withdraw Date:
1.0 11/6/2013 11/6/2015
This CRF has been reviewed for completion prior to completion of the study visit Tech Initials _______
Page 13 of 17
Study Number 3931OSM0415
VISIT WEEK 4 JULY 13, 2015
ROOM: TREATMENT 3
(IMAGING) DEVICE
NUMBER:
TIME TEMPERATURE (°F) HUMIDITY (%RH) TECHNICIAN INITIALS
Temperature and Humidity Log
FORM Number: 035 Version: Implementation Date: Theoretical Withdraw Date:
1.0 11/6/2013 11/6/2015
This CRF has been reviewed for completion prior to completion of the study visit Tech Initials _______
Page 14 of 17
Instructions: Indoor temperature and humidity will be recorded every hour for studies involving temperature/humidity sensitive evaluations. For all studies, outdoor temperature and humidity conditions will be recorded each day and indoor temperature and humidity will be recorded at three time intervals, prior to first subject arrival/acclimation, halfway through the study visit, and upon completion of the study visit. A temperature and humidity log should be used for each room used in the study.
Study Number 3931OSM0415
VISIT WEEK 8 AUGUST 10, 2015
OUTDOOR CONDITIONS
TEMPERATURE (°F) HUMIDITY (%RH)
High: High:
Low: Low:
Average: Average:
Source:
INDOOR CONDITIONS
ROOM:
RECEPTION AREA
DEVICE NUMBER:
TIME TEMPERATURE (°F) HUMIDITY (%RH) TECHNICIAN
INITIALS
Temperature and Humidity Log
FORM Number: 035 Version: Implementation Date: Theoretical Withdraw Date:
1.0 11/6/2013 11/6/2015
This CRF has been reviewed for completion prior to completion of the study visit Tech Initials _______
Page 15 of 17
Study Number 3931OSM0415
VISIT WEEK 8 AUGUST 10, 2015
ROOM: TREATMENT 1
(VISUAL) DEVICE
NUMBER:
TIME TEMPERATURE (°F) HUMIDITY (%RH) TECHNICIAN INITIALS
Temperature and Humidity Log
FORM Number: 035 Version: Implementation Date: Theoretical Withdraw Date:
1.0 11/6/2013 11/6/2015
This CRF has been reviewed for completion prior to completion of the study visit Tech Initials _______
Page 16 of 17
Study Number 3931OSM0415
VISIT WEEK 8 AUGUST 10, 2015
ROOM: TREATMENT 2
(CUTOMETER/COSMETRICS) DEVICE
NUMBER:
TIME TEMPERATURE (°F) HUMIDITY (%RH) TECHNICIAN INITIALS
Temperature and Humidity Log
FORM Number: 035 Version: Implementation Date: Theoretical Withdraw Date:
1.0 11/6/2013 11/6/2015
This CRF has been reviewed for completion prior to completion of the study visit Tech Initials _______
Page 17 of 17
Study Number 3931OSM0415
VISIT WEEK 8 AUGUST 10, 2015
ROOM: TREATMENT 3
(IMAGING) DEVICE
NUMBER:
TIME TEMPERATURE (°F) HUMIDITY (%RH) TECHNICIAN INITIALS
Reimbursement Form
Study Number 3931OSM0415
Subject Initials
Subject Number
PLEASE PRINT CLEARLY, FILL IN ALL FORM FIELDS DO NOT WRITE IN SHADED AREAS
- - Social Security Number
First Name M.I. Last Name
Street Apt. /Suite
City / Town State Zip Code
39310SM0415
$ 175.00
Department / Study Amount
Payment Terms: Please read ClinCard information. I_____________________________ have received my payment and agree to the ClinCard terms. Sign your name
IRSI, Inc. Protocol No. 3931OSM0415 Final Protocol Ver. 2.6 June 29, 2015
CONFIDENTIAL Appendix IV
Appendix IV
Informed Consent Form and Photograph Release Form
INFORMED CONSENT FORM Study Number: 3931OSM0415
An Eight-Week Clinical Study to Evaluate the Efficacy of One
Product on Skin Condition (Catalyst AC-11)
Date of ICF Approval REVISED - June 15, 2015
Subject Initials: _______
Page 1 of 8
This consent form may contain word(s) that you do not understand. Please ask the study staff to explain any word(s) or information that you do not clearly understand. You are entitled to a copy of this Consent Form and one will be provided to you today.
1.0 PURPOSE
You are being asked to participate in a research study to assess and compare the effects of three formulations compared to a vehicle control on facial skin appearance and condition. This study is also being conducted to evaluate the facial skin tolerance of the three formulations.
2.0 ENROLLMENT
Certain enrollment criteria are required for this study. If you do not meet these criteria you will not be enrolled in this study. Below is a list of enrollment requirements.
Inclusion Criteria
1. Females, in good general health, and between the ages of 35 and 59 years old, inclusive, at time of enrollment.
2. Subjects with lines and wrinkles and eyelid laxity as determined by an expert grader at Baseline. a. Score of ≥2 cm on 10 cm VAS for fine lines/wrinkles (crow’s feet) b. Score of ≥2 cm on 10 cm VAS for eyelid laxity
3. A portion of the panel (approximately n=10) with Capillary visibility (telangiectasia) a. Score of ≥2 cm on 10 cm VAS for capillary visibility
4. A portion of the panel (approximately n=10) with actinic keratosis as determined by an expert grader at baseline.
a. Score of ≥2 cm on 10 cm VAS for actinic keratosis severity 5. Willing to be photographed and sign a photograph release form. 6. Able to read, understand and willing to sign an ICF, including HIPAA and state requirements,
complete a brief personal/medical history 7. Dependable and willing to attend study visits and comply with all study instructions and
requirements, including but not limited to: a. Willing to abstain from any other superficial or deep facial procedure during the study
(dermabrasion, microdermabrasion, peels, photo facials, laser treatment, facial lesion removal, etc.).
b. Willing to abstain from use of all other topical products for the duration of the washout period and study period.
c. Willing to abstain from the use of tanning bed use and recreational sun exposure on the face for the duration of the washout period and study period.
Exclusion Criteria
1. Subjects using systemic or topical steroids, Accutane, oral or topical estrogens, and/or other
medicines affecting skin in a major way during study period or washout period.
INFORMED CONSENT FORM Study Number: 3931OSM0415
An Eight-Week Clinical Study to Evaluate the Efficacy of One
Product on Skin Condition (Catalyst AC-11)
Date of ICF Approval REVISED - June 15, 2015
Subject Initials: _______
Page 2 of 8
2. Subjects with present or previous inflammatory or other skin diseases, such as rosacea, severe acne,
Systemic Lupus Erythematosus (SLE), dermatomyositis, scleroderma, etc.
3. Current or Smokers within one month prior to enrollment
General exclusion criteria:
4. Subjects participating in any other clinical studies
5. Subjects having an acute or chronic disease or medical condition, including dermatological problems,
which could put her at risk in the opinion of the Principal Investigator or compromise study
outcomes. Typical uncontrolled chronic or serious diseases and conditions which would prevent
participation in any clinical trial are cancer, AIDS, diabetes, morbid obesity, renal impairment, mental
illness, drug/alcohol addiction.
6. Subjects who are unreliable or unlikely to be available for the duration of the study
7. History of allergic reactions, skin sensitization and/or known allergies to cosmetic ingredients,
toiletries, sunscreens, etc.
8. Immunocompromised subjects
9. Woman who started Hormone Replacement Therapy within the last three months preceding the
screening visit
10. Woman using oral contraception for less than three months before the screening visit or who has
changed her contraceptive method within the three months before the Baseline visit or planning to
modify her contraception treatment within the duration of the study
11. Woman known to be pregnant, lactating or planning to become pregnant within six months. Subjects
who become pregnant during the study must inform the Principal Investigator immediately
12. Individuals unable to communicate or cooperate with the Principal Investigator due to language
problems, poor mental development, or impaired cerebral function
13. Employees of IRSI or other testing firms/ laboratories, cosmetic or raw goods manufacturers or
suppliers
3.0 PROCEDURES
You are being asked to voluntarily participate in an Eight (8) Week Treatment Period study involving four (4) visits to the test site (including today’s visit). The study will also involve a washout period that is approximately seven days. The study will include approximately thirty (30) test subjects. At today’s visit you will be asked to read and sign this informed consent prior to receiving any study instructions. You will also be asked to complete a brief medical/personal history. Qualification for study participation will be evaluated by an IRSI technician using information collected from your medical history as well as an inclusion/ exclusion checklist. If you qualify at this visit, you will continue onto the washout portion of the study. Final qualification and enrollment into the study will occur at the Baseline study visit. If you qualify today, you will be given the Dove Beauty Bar, White Skin Cleanser to be used for all facial cleansing during the washout period. You will also be provided with Dual Purpose Treatment Moisture with SPF 15 to be applied daily in the morning prior to sun exposure and reapply every two hours as needed throughout
INFORMED CONSENT FORM Study Number: 3931OSM0415
An Eight-Week Clinical Study to Evaluate the Efficacy of One
Product on Skin Condition (Catalyst AC-11)
Date of ICF Approval REVISED - June 15, 2015
Subject Initials: _______
Page 3 of 8
the day during sun exposure. You will also receive instructions regarding the discontinuation of other facial skin products and other restriction during the study, along with your return visit dates. At the Baseline Visit you will be required to arrive at the testing site with a clean facial skin, having washed your face and applied no topical treatment or cosmetic products within one hour prior to your scheduled visit. Once you arrive you will be required to wait at least fifteen (15) minutes with your face exposed prior to any assessments. You will then be questioned for any changes in your medical history as well as compliance to the study instructions. You will be evaluated by a trained IRSI evaluator for signs of photodamaged skin to confirm your qualification into the study. If qualified, you will be enrolled into the study. You will then undergo non-invasive, bio-instrumental and photography evaluations. An IRSI technician will apply the test product on your face for the first time at the testing site. Approximately, fifteen minutes after application, you will again undergo non-invasive visual grading assessment and bio-instrumental evaluations. In addition, you will be asked to complete a questionnaire regarding your opinion of the product and its effects. Upon completion of post-application evaluations you will be dismissed from the Baseline visit and schedule your Week 1 (1) visit. At Week One (1) Visit, you will be required to arrive at the testing center with a clean facial skin, having washed your face, and applied no topical treatment or cosmetic products within one hour prior to your scheduled visit. Once you arrive you will be required to wait at least fifteen (15) minutes with your face exposed prior to any assessments. You will then be questioned for any changes in your medical history as well as compliance to the study instructions. You will undergo non-invasive expert visual grading, bio-instrumental and photography evaluations. In addition, you will be asked to complete a questionnaire regarding your opinion of the product and its effects. You will return the test product for inspection and your diary will be reviewed and returned to you. Upon completion of Week 1 evaluations, you will be dismissed from the Week One (1) Visit and scheduled for your Week Four (4) Visit. At Week Four (4) Visit, you will be required to arrive at the testing center with a clean facial skin, having washed your face, and applied no topical treatment or cosmetic products within one hour prior to your scheduled visit. Once you arrive you will be required to wait at least fifteen (15) minutes with your face exposed prior to any assessments. You will then be questioned for any changes in your medical history as well as compliance to the study instructions. You will undergo non-invasive expert visual grading, bio-instrumental and photography evaluations. In addition, you will be asked to complete a questionnaire regarding your opinion of the product and its effects. You will return the test product for inspection and your diary will be reviewed and returned to you. Upon completion of Week 4 evaluations, you will be dismissed from the Week four (4) visit and scheduled for your week eight (8) visit. At Week Eight (8) Visit, you will be required to arrive at the testing center with a clean facial skin, having washed your face and applied no topical treatment or cosmetic products within one hour prior to your scheduled visit. Once you arrive you will be required to wait at least fifteen (15) minutes with your face exposed prior to any assessments. You will then be questioned for any changes in your medical history as well as compliance to the study instructions. You will undergo non-invasive expert visual grading, bio-instrumental and photography evaluations. In addition, you will be asked to complete a questionnaire regarding your opinion of the product and its effects. The test product and diary will be collected and reviewed. Upon completion of Week 8 evaluations, you will receive your stipend for the study participation and you will be dismissed from the study.
INFORMED CONSENT FORM Study Number: 3931OSM0415
An Eight-Week Clinical Study to Evaluate the Efficacy of One
Product on Skin Condition (Catalyst AC-11)
Date of ICF Approval REVISED - June 15, 2015
Subject Initials: _______
Page 4 of 8
3.1 PRODUCT APPLICATION
All subjects will receive treatment in this clinical study. One topical product is being evaluated on its ability to improve skin condition. In addition to the test product, three supporting products will also be incorporated as a regimen for the duration of the study. You will use the regimen daily as per sponsor instruction for eight weeks. You will also be given Dove Beauty Bar – white to use as a facial cleanser, and Dual Purpose Treatment Moisture with SPF 15 to use as your moisturizer with SPF for the study duration. 3.2 EXPERT GRADER ASSESSMENTS
At each visit you will have your face visually evaluated by a trained expert grader or technician. Visual assessments can include how the product looks or feels on your skin or how your skin appears without product on the skin.
3.3 INSTRUMENTAL EVALUATION
At each visit, you will have your skin evaluated by bio-Intrumentation. Two instruments will be used during the study: Cosmetrics ™SIAscope and Cutometer.
The SIAscope is an optical skin imaging instrument which uses a probe to measure components of your skin, including melanin, hemoglobin and collagen. For the purposes of this study, dermal hemoglobin measurements will be taken in duplicate and averaged on a spot determined at Baseline with visible red capillaries, at Baseline, Week 1, Week 4 and Week 8. The same location will be measured at each time point and recorded using a face map. This is a painless and non-invasive procedure
The Cutometer uses the light suction to evaluate the firmness and elasticity of your skin. Two consecutive measurements will be taken on your left or right cheek following a randomization code list. Measurements will be taken at each time point: Baseline, Immediately fifteen minutes after product application (T15M), Week 1, Week 4 and Week 8 Visits.
3.4 SUBJECTIVE QUESTIONNAIRE
You will be asked to complete a questionnaire regarding your level of agreement with the statements about product performance, using a five point scale at the following time point: Week 1, Week 4 and Week 8 Visits.
3.5 PHOTOGRAPHY ASSESSMENTS
A subgroup of five (5) subjects will be randomly selected to have photographs taken of their face at Baseline, Week 1, Week 4 and Week 8 Visits. One of the full front face, one left profile and one right profile using the Clarity 2D research Ti system.
INFORMED CONSENT FORM Study Number: 3931OSM0415
An Eight-Week Clinical Study to Evaluate the Efficacy of One
Product on Skin Condition (Catalyst AC-11)
Date of ICF Approval REVISED - June 15, 2015
Subject Initials: _______
Page 5 of 8
Photographs will be for documentation purposes only. You will be required to sit with your face in a photography booth for a short period of time. A black cape and headband will be provided for you to wear during the imaging; you will be responsible for bringing the black headband to each study visit. This procedure is non-invasive and painless.
4.0 COMPENSATION
You will receive $175.00 for completing the study as directed. If you are not qualified for this study you will not be compensated. If you are present and qualified, but not enrolled due to overbooking, you will be paid $30.00. Please note that it is the policy of IRSI to overbook all studies due to high rates of cancellations and no-shows. Completing the study paperwork does not guarantee enrollment into the study, even if you meet the entry criteria and qualify. If you are discontinued from the study you will be paid on the basis of the visits you have completed at $30.00 per visit.
If you withdraw from this study for personal reasons unrelated to the test materials, you will not be compensated. If you are disqualified for refusal to obey rules, follow instructions or attend all visits as scheduled, you will not be compensated.
This is a voluntary study and you may withdraw at any time without obligation or prejudice. The sponsor and/or investigative staff may remove you from this study at any time for any reason without loss of benefits, except as stated above.
Payment will be by Clincard within approximately 24 hours of the final study visit if not available the day of the final visit.
5.0 POTENTIAL BENEFIT
You may notice an improvement in your facial skin condition during the eight (8) week treatment period. However, the amount is unknown and will vary among participants.
6.0 POTENTIAL RISKS
The test product is for you ONLY to use. The product is for external use only.
You may develop irritation on your face. If a study area becomes irritated, you should contact IRSI immediately. It is possible to develop a reaction to products such as those being tested and the cleanser being used throughout the study period including but not limited to stinging, redness, dryness, flaking, burning, rash and itching. Some risks are unknown and you will be advised if more information becomes available.
If you have a history of reactions to cosmetics or moisturizing products you must not participate in this study. If you have no history of sensitivity the likelihood of a reaction is minimal and similar to that if you purchased and used comparable products on your own.
Reactions, if any, usually occur at or around the test area(face) but are not limited to these areas. Reactions may persist in some individuals. In the event of a reaction you should immediately contact:
INFORMED CONSENT FORM Study Number: 3931OSM0415
An Eight-Week Clinical Study to Evaluate the Efficacy of One
Product on Skin Condition (Catalyst AC-11)
Date of ICF Approval REVISED - June 15, 2015
Subject Initials: _______
Page 6 of 8
Robigaile, Study Coordinator at (914) 937-6500, Ext. 132
In the event of a medical emergency, you should seek medical attention first and then contact IRSI.
If you experience an injury as a direct result of administration of the test material, the study sponsor agrees to pay medical expenses necessary to treat such injury: (1) To the extent you are not otherwise reimbursed by your own medical insurance, (2) provided you have followed the directions of the investigator before and after the injury occurred. Additional financial compensation will not be provided. Medical follow-up will be provided until the investigator or study coordinator determines you have recovered.
If you withdraw due to personal reasons related to product usage other than a response judged by IRSI staff to be a reaction to test product or instructions, you may not be paid. If, in the judgment of the investigative staff, it is best to discontinue your participation for reasons such as a documented medical condition not related to study materials, product failure or study termination, you will be paid for that portion of the study you have completed (pro rata), according to the number of scheduled visits made to the office. If your participation in the study is stopped due to an adverse reaction related to use of the test material or test instructions, you will be paid the full stipend amount.
If you are pregnant or planning on becoming pregnant or at significant risk of becoming pregnant during this test, you should not enroll in the test. Although no side effects to pregnancy are expected from the test materials the risks are unknown. If you become pregnant during the test you will immediately stop product use and notify IRSI.
For safety reasons, even if you drop from this study you may be asked to make follow-up visits to the study facility or to a physician. In the event of a reaction this is especially important for your safety and so that accurate information can be obtained.
7.0 CONFIDENTIALITY OF RECORDS
Reports prepared by IRSI use statistical information only and at no time will your name be used in these reports. The sponsor, the FDA and Allendale Investigational Review Board and others in certain legal action, may inspect the records of this study which will include your name, medical records and, if applicable, personal information relating to your participation.
By signing this consent form you authorize the release of your medical records, only for treatment of illnesses and injuries related to this study to IRSI, and the study sponsor. IRSI will not release any information in your medical records except as stated in this consent.
INFORMED CONSENT FORM Study Number: 3931OSM0415
An Eight-Week Clinical Study to Evaluate the Efficacy of One
Product on Skin Condition (Catalyst AC-11)
Date of ICF Approval REVISED - June 15, 2015
Subject Initials: _______
Page 7 of 8
8.0 USE OF PERSONAL INFORMATION (HIPAA) AUTHORIZATION
Your participation in this study will involve disclosing some of your personal data and medical information (allergies, medications, illnesses, conditions and demographics {age, sex, race, and occupation}) as well as name, address, email address, Social Security Number, and phone number to IRSI.
The Study Coordinator, Investigator or authorized staff member may ask you for this information. By signing this consent form you authorize the release of your medical records (for treatments, illnesses and injuries as a direct result of test material use) to IRSI.
The same staff and management that write IRSI’s reports will review or use the medical information you report. At no time will your name, address, phone number, email address or social security number be published in a report. The study Sponsor, the Allendale Institutional Review Board, and the FDA may be granted access to your personal information regarding this study. IRSI will use the medical information you provide in order to conduct this study.
Additionally, IRSI will use the medical information in its database so that IRSI may be able to contact you to participate in future studies. Therefore, your authorization to IRSI to use the medical information and data you provide has no end date.
You have the right to revoke this authorization so long as IRSI has not already relied on or used the information you provided for this study. At your written request, IRSI will not contact you for future studies. Only employees who have signed a confidentiality agreement are permitted to access the database. IRSI does not sell the identifying information in the database. Even if you take back your consent to participate in this study the Use of Personal Information authorization will remain in effect.
Your signature below indicates you have read the above privacy statement.
Signature:
Date:
INFORMED CONSENT FORM Study Number: 3931OSM0415
An Eight-Week Clinical Study to Evaluate the Efficacy of One
Product on Skin Condition (Catalyst AC-11)
Date of ICF Approval REVISED - June 15, 2015
Page 8 of 8
9.0 CONSENT OF SUBJECT
I have read and fully understand this consent and what is required of me during this study. I understand the risks, benefits and procedures and that I am free to ask questions at any time. I have no questions at this time. Additional information regarding the test material may become available to me during this study. If additional information becomes available or the study procedures are changed and this affects my well-being a new consent form will be provided to me. By signing this consent I authorize the release of my medical records in the event of an illness, injury or reaction related to this study. The investigator or a member of the staff will be available at (914) 937-6500 to answer my questions. I have read this consent and I freely and voluntarily agree to participate in this study as described to me. By signing this form I forfeit none of my legal rights.
Signature: Date:
Print Name:
Last: First: M.I:
Street Address: City: State: Zip:
Home Phone: Cell Phone: Work Phone:
E-Mail Address:
Social Security Number:
DO NOT WRITE BELOW THIS LINE
*************************************************************************************
Witness Signature: Person Administering Consent (IRSI Personnel)
Signature: Date:
Print Name:
Last: First:
Model Release Form
Study Number 3931OSM0415
Subject Initials
Subject Number
Page 1 of 1
Consent given to: International Research Services, Inc. 222 Grace Church Street Port Chester, N.Y. 10573 For valuable consideration, I hereby irrevocably consent to and authorize the use and reproduction by you, or anyone authorized by you, of any and all photographs which you have taken of me, negative and positive, proofs of which are hereto attached, for any purpose whatsoever, throughout the world, without further compensation to me. All negatives and positives, together with the prints shall constitute the property of IRSI and/or the study sponsor, solely and completely. By signing below, I agree to the above statement and attest that I am 18 years of age or older at the time of study enrollment and the date of the signing of this document: Name: _______________________________________ (Please print) Model: ______________________________________ (Signature of model)
Date: ________________________________________
Address: ________________________________ _________________ _______ _________
(Street) (City) (State) (Zip) Witnessed by: _________________________________
(Signature of witness) Date: _________________________________________
IRSI, Inc. Protocol No. 3931OSM0415 Final Protocol Ver. 2.6 June 29, 2015
CONFIDENTIAL Appendix V
Appendix IV
Randomization Code(s)
RANDOMIZATION CODE CUTOMETER
Study Number 39310SM0415
Randomization Details: Randomize location of instrument measurement
Page 1 of 1
SUBJ # Cheek SUBJ # Cheek
01 L 19 R
02 R 20 L
03 L 21 L
04 L 22 R
05 R 23 R
06 R 24 L
07 L 25 R
08 L 26 L
09 R 27 R
10 R 28 L
11 L 29 L
12 R 30 R
13 L 31 R
14 R 32 L
15 R 33 L
16 L 34 R
17 L 35 R
18 R 36 L
IRSI, Inc. Protocol No. 3931OSM0415 FINAL Report Ver. 2.2 October 21, 2015
CONFIDENTIAL Appendix II
Appendix II
Protocol Deviations
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DN: cn=Kimberly A. Hammon, o=IRSI, ou=Quality
Assurance, [email protected], c=US
Date: 2015.10.28 10:09:24 -04'00'
IRSI, Inc. Protocol No. 3931OSM0415 FINAL Report Ver. 2.2 October 21, 2015
CONFIDENTIAL Appendix III
Appendix III
Adverse Events
IRSI, Inc. Protocol No. 3931OSM0415 FINAL Report Ver. 2.2 October 21, 2015
CONFIDENTIAL Appendix IV
Appendix IV
Statistical Report and Data Listing
Page 1 of 117
08/31/15.3
INTERNATIONAL RESEARCH SERVICES, INC.
SKIN CONDITION STUDY #3931OSM0415
MEDICAL HISTORY
E R F B F S E L O
INI- T A A O I K Y E C
SUBJ TIAL HGT WGT AGE H C C D T I E N C SPECIFY
---- ---- ---- --- --- N E E Y Z N S S U -------------------------
01 V-G 63.0 200 48 N W N N 3 N N N U
02 L-P 67.0 160 52 N W C N 4 N N Y E T.A.
03 T-H 65.0 140 59 N W C N 3 N N Y E SPECIAL ED AIDE
04 A-B 59.0 103 35 N W N N 4 N N N H
05 L-D 64.5 190 56 N W N N 4 N N N H
06 MTI 69.0 180 56 N W C N 2 N N N E AFTERSCHOOL COORDINATOR
07 A-D 67.0 140 52 N W N N 3 N N N U
08 GPC 64.0 130 45 H C D 4 Y Y N H
09 EJG 68.0 200 37 N W N N 1 N N N E SELF (RESTAURANT)
10 R-D 60.0 103 58 N W N N 3 N N N R
12 K-P 65.0 112 46 N W D D 2 N N N E SELF - TEACHER
13 AKG 60.0 96 49 N W C N 2 N N N E LUNCH MONITOR
14 M-A 61.0 178 48 H N N 3 N N N H
15 AMI 69.0 190 57 H N N 2 N N N H
16 CMM 63.0 216 43 N W O N 5 N N N E PHLEBOTONIST
18 BDL 65.0 165 47 N W C N 3 Y Y Y E PROGRAM COORDINATOR
19 LSM 67.0 150 50 N W N N 3 N N Y E WAITRESS
20 LMM 63.0 150 55 H W C D 2 N N N E USPS MAIL HANDLER
21 S-L 64.0 240 57 N W C D 3 N N N E OFFICE MANAGER
22 CAK 68.0 200 52 N W N N 2 N N N H
23 SMS 62.0 200 48 N W N N 3 N N N U
24 L-G 64.0 220 60 N W C D 3 N N N R
25 SLM 64.0 190 49 N W D N 2 N N N H
Page 2 of 117
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INTERNATIONAL RESEARCH SERVICES, INC.
SKIN CONDITION STUDY #3931OSM0415
MEDICAL HISTORY
E R F B F S E L O
INI- T A A O I K Y E C
SUBJ TIAL HGT WGT AGE H C C D T I E N C SPECIFY
---- ---- ---- --- --- N E E Y Z N S S U -------------------------
26 J-A 63.0 169 59 N W C N 2 N Y N R
27 N-S 63.0 130 59 N W N N 3 Y Y Y U
28 D-R 62.0 170 59 H C N 4 N N N R
29 L-Z 69.0 300 58 N W C N 2 N N N R
30 J-B 66.0 173 49 N B C D 4 N N N U
31 NLA 63.5 150 58 N W D D 3 N N N H
32 BJB 61.0 150 54 N W N N 3 N N Y H
33 P-G 65.0 135 58 N W N N 3 N N N H
35 G-T 64.0 148 49 N W C D 2 Y Y N E REAL ESTATE
36 J-T 60.0 130 38 H C N 3 N N N E RECEPTIONIST
Page 3 of 117
08/31/15.3
INTERNATIONAL RESEARCH SERVICES, INC.
SKIN CONDITION STUDY #3931OSM0415
EXPERT VISUAL GRADING
ELAS ACTINIC
EVAL TEX- FINE RADI EYELID TIC OVER CAPIL- KERA-
TIME TURE LINE ANCE LAXITY ITY ALL LARY TOSIS
------ ---- ---- ---- ------ ---- ---- ------ -------
** SUBJECT = 01
BASE 4.3 4.6 4.1 4.1 3.8 4.7 4.1
IMMED 4.0 4.1 4.1 4.0 3.4 4.3 4.2
WK-1 4.5 4.5 5.3 4.2 4.3 4.5 3.8
WK-4 4.4 3.6 3.7 3.2 3.9 4.4 4.0
WK-8 4.2 3.7 4.0 2.5 3.5 3.9 3.1
** SUBJECT = 02
BASE 4.3 4.6 5.4 4.6 3.9 5.2 3.9
IMMED 3.1 4.1 3.7 4.5 3.7 4.9 3.4
WK-1 4.4 5.3 4.8 4.9 3.8 4.9 3.1
WK-4 4.1 4.2 4.8 4.1 4.0 4.4 3.2
WK-8 3.8 3.9 3.9 3.7 3.9 4.2 2.5
** SUBJECT = 03
BASE 4.3 5.7 4.7 4.3 4.3 5.0
IMMED 3.4 4.9 3.3 4.2 4.2 4.1
WK-1 3.8 5.6 4.6 4.1 3.9 4.5
WK-4 3.9 5.4 3.6 4.5 4.5 5.2
WK-8 3.3 4.7 2.6 4.2 3.7 4.0
** SUBJECT = 04
BASE 4.3 2.5 4.5 2.3 3.7 4.1 4.0
IMMED 3.4 2.3 2.8 2.7 2.7 2.9 3.7
WK-1 4.1 2.5 3.5 2.6 3.2 4.0 3.5
WK-4 4.2 2.7 3.9 2.4 3.7 4.4 3.4
WK-8 3.4 1.3 2.0 1.8 2.5 2.3 2.1
** SUBJECT = 05
BASE 3.8 4.7 4.8 4.7 3.9 4.8 5.1
IMMED 3.3 4.5 2.8 4.3 3.8 4.9 5.2
WK-1 3.4 5.9 5.2 4.5 3.9 4.9 5.1
WK-4 3.7 5.2 3.8 3.4 3.9 4.2 4.8
WK-8 3.9 4.3 3.5 2.7 3.5 3.8 4.2
** SUBJECT = 06
BASE 4.5 5.6 5.3 4.9 4.5 5.0 4.7
IMMED 2.9 5.0 2.6 4.7 3.8 4.5 4.8
WK-1 4.3 5.8 5.7 5.6 4.8 5.2 5.3
WK-4 3.9 5.1 4.4 4.3 4.1 4.4 4.5
WK-8 3.9 4.3 3.2 4.2 3.5 4.3 3.5
** SUBJECT = 07
BASE 3.8 4.7 4.6 4.7 4.2 4.5
IMMED 3.3 4.3 2.2 4.2 3.5 4.0
WK-1 4.3 4.9 4.4 3.1 3.6 3.9
WK-4 4.3 4.2 4.2 3.8 4.1 4.3
WK-8 3.5 3.2 3.8 3.5 3.6 3.9
Page 4 of 117
08/31/15.3
INTERNATIONAL RESEARCH SERVICES, INC.
SKIN CONDITION STUDY #3931OSM0415
EXPERT VISUAL GRADING
ELAS ACTINIC
EVAL TEX- FINE RADI EYELID TIC OVER CAPIL- KERA-
TIME TURE LINE ANCE LAXITY ITY ALL LARY TOSIS
------ ---- ---- ---- ------ ---- ---- ------ -------
** SUBJECT = 08
BASE 4.3 3.9 4.3 2.8 3.7 4.4
IMMED 4.3 3.4 4.3 2.8 3.7 4.5
WK-1 4.0 2.5 4.0 3.3 3.6 3.8
WK-4 4.2 4.0 4.3 2.8 4.0 4.1
WK-8 3.7 2.2 3.1 3.0 3.6 3.8
** SUBJECT = 09
BASE 4.1 2.8 4.8 2.4 3.9 4.8 2.6
IMMED 2.8 2.7 2.3 2.1 3.2 3.4 2.2
WK-1 4.4 3.8 4.8 3.9 3.9 4.6 4.5
WK-4 3.4 2.8 3.9 3.4 3.4 3.2 3.2
WK-8 3.5 2.4 3.7 2.6 3.4 3.8 3.6
** SUBJECT = 10
BASE 4.9 6.4 5.4 4.6 3.8 5.2
IMMED 2.8 5.8 2.7 4.0 3.5 4.3
WK-1 5.2 5.9 5.5 5.4 4.3 5.2
WK-4 4.2 4.7 4.7 3.8 4.5 4.7
WK-8 4.0 3.9 2.8 2.8 3.9 4.2
** SUBJECT = 12
BASE 4.2 5.4 4.9 5.4 4.5 4.9
IMMED 2.7 4.6 2.4 5.1 4.1 5.0
WK-1 3.9 5.6 4.5 4.3 3.8 4.5
WK-4 4.1 5.4 4.8 4.1 4.0 4.8
WK-8 3.0 4.1 3.3 3.5 3.6 3.8
** SUBJECT = 13
BASE 4.7 4.3 4.4 2.8 3.6 4.8 4.4
IMMED 3.7 3.6 3.3 2.6 2.8 3.9 3.5
WK-1 4.2 4.5 4.5 4.0 3.9 4.5 4.1
WK-4 4.5 3.6 4.0 3.0 3.8 4.3 3.4
WK-8 3.9 3.5 1.5 2.8 2.8 3.2 2.5
** SUBJECT = 14
BASE 4.8 4.1 5.1 2.8 3.7 4.8 3.7
IMMED 4.0 3.3 2.9 2.4 3.5 4.2 3.3
WK-1 3.7 3.0 4.6 3.0 3.8 4.4 3.0
WK-4 4.4 2.3 4.1 2.9 3.9 4.2 3.3
WK-8 3.3 2.6 3.1 2.7 3.5 3.3 3.5
Page 5 of 117
08/31/15.3
INTERNATIONAL RESEARCH SERVICES, INC.
SKIN CONDITION STUDY #3931OSM0415
EXPERT VISUAL GRADING
ELAS ACTINIC
EVAL TEX- FINE RADI EYELID TIC OVER CAPIL- KERA-
TIME TURE LINE ANCE LAXITY ITY ALL LARY TOSIS
------ ---- ---- ---- ------ ---- ---- ------ -------
** SUBJECT = 15
BASE 4.3 4.7 5.1 4.4 4.6 5.1 3.9
IMMED 3.4 4.2 3.2 4.1 3.8 4.5 3.8
WK-1 4.2 5.3 4.7 4.0 4.0 4.6 4.5
WK-4 4.2 4.3 4.3 3.5 4.3 4.5 4.2
WK-8 4.0 3.5 2.9 3.3 3.4 4.4 2.9
** SUBJECT = 16
BASE 4.5 2.6 3.7 2.8 3.9 5.0
IMMED 2.7 2.3 3.1 2.4 3.5 4.7
WK-1 3.6 4.5 3.5 3.2 3.7 4.3
WK-4 4.4 3.8 4.1 3.0 3.9 4.5
WK-8 4.1 2.3 2.8 2.5 3.5 4.1
** SUBJECT = 18
BASE 4.4 4.2 4.7 3.2 3.8 4.4 3.1
IMMED 2.7 3.7 2.7 2.7 3.5 4.2 2.8
WK-1 4.3 5.3 5.4 3.5 3.8 4.9 3.4
WK-4 4.2 4.5 3.9 3.9 3.9 4.4 3.4
WK-8 3.4 4.0 3.5 3.0 3.1 3.8 2.7
** SUBJECT = 19
BASE 4.1 3.9 5.2 2.6 3.5 5.1 5.1
IMMED 2.8 3.1 2.8 2.5 3.2 4.4 4.9
WK-1 4.5 4.2 5.7 2.7 3.7 5.2 5.1
WK-4 4.2 3.2 4.4 3.0 4.0 4.7 4.7
WK-8 4.1 3.4 4.1 3.1 3.3 3.9 3.5
** SUBJECT = 20
BASE 4.3 3.3 5.1 2.8 3.7 4.8 3.6
IMMED 2.9 2.6 2.6 2.8 2.8 2.9 3.4
WK-1 4.0 4.5 4.2 3.5 3.7 4.2 3.5
WK-4 3.8 3.1 3.8 2.8 3.6 3.8 2.9
WK-8 2.7 2.3 2.5 2.8 3.4 3.0 3.2
** SUBJECT = 21
BASE 3.5 4.1 4.6 2.8 3.7 4.9 5.1
IMMED 2.7 3.5 2.7 3.1 3.5 3.7 4.8
WK-1 4.6 4.8 4.8 4.0 4.1 4.5 5.2
WK-4 4.2 4.6 4.3 3.9 4.2 4.4 4.2
WK-8 4.1 3.9 2.9 2.9 3.6 4.1 3.9
** SUBJECT = 22
BASE 4.1 4.2 5.1 4.2 3.9 4.7 3.9
IMMED 2.3 3.7 3.3 4.0 2.8 4.1 3.7
WK-1 4.2 5.8 5.0 4.1 4.0 5.0 4.0
WK-4 4.5 4.9 4.6 4.0 4.1 4.6 3.9
WK-8 3.8 4.2 3.5 3.1 3.5 3.7 2.8
Page 6 of 117
08/31/15.3
INTERNATIONAL RESEARCH SERVICES, INC.
SKIN CONDITION STUDY #3931OSM0415
EXPERT VISUAL GRADING
ELAS ACTINIC
EVAL TEX- FINE RADI EYELID TIC OVER CAPIL- KERA-
TIME TURE LINE ANCE LAXITY ITY ALL LARY TOSIS
------ ---- ---- ---- ------ ---- ---- ------ -------
** SUBJECT = 23
BASE 4.1 4.4 4.8 4.2 3.6 4.7 3.7
IMMED 2.7 3.6 3.1 3.8 3.4 3.9 3.3
WK-1 4.7 5.1 4.2 3.2 3.9 4.8 4.0
WK-4 3.9 4.2 4.0 3.7 4.0 4.6 3.1
WK-8 3.2 4.1 2.4 3.7 3.7 4.2 2.6
** SUBJECT = 24
BASE 4.4 4.8 5.2 4.3 3.6 5.2 5.8
IMMED 3.7 4.3 2.7 4.1 3.0 4.4 5.4
WK-1 4.4 5.1 4.4 2.9 3.5 4.6 5.4
WK-4 4.3 4.3 4.4 4.2 4.0 4.3 4.1
WK-8 3.0 3.9 2.4 3.5 3.6 4.0 3.9
** SUBJECT = 25
BASE 3.9 3.9 4.7 4.0 3.6 5.1 5.3 4.4
IMMED 2.2 3.6 3.3 3.7 3.3 4.6 5.1 4.1
WK-1 4.7 4.9 5.2 3.9 4.1 4.6 5.1 3.8
WK-4 4.7 4.4 5.1 4.2 4.5 4.8 4.8 3.7
WK-8 4.1 4.1 3.8 3.5 3.0 3.7 4.2 3.9
** SUBJECT = 26
BASE 4.1 4.1 4.5 4.7 4.3 4.9 4.5
IMMED 3.4 3.7 2.9 4.2 3.8 4.3 4.1
WK-1 3.8 4.3 4.4 4.2 5.0 4.5 3.9
WK-4 3.8 3.6 4.1 3.5 3.8 4.4 3.7
WK-8 2.8 3.1 3.4 3.3 3.8 3.8 3.3
** SUBJECT = 27
BASE 4.7 4.5 5.2 5.0 4.1 5.1 4.6 2.9
IMMED 4.4 4.0 4.0 4.7 3.6 5.0 4.5 2.8
WK-1 4.9 4.5 5.3 4.2 4.2 5.0 4.0 3.6
WK-4 4.3 4.0 4.4 4.2 4.1 4.4 3.9 2.7
WK-8 4.3 4.1 4.5 4.5 4.1 4.5 3.1 2.7
** SUBJECT = 28
BASE 3.5 3.8 3.9 3.9 3.7 3.8 3.6 3.3
IMMED 2.8 3.2 3.3 3.7 3.6 3.8 3.7 3.2
WK-1 4.0 4.0 3.7 2.9 3.1 4.6 3.6 3.2
WK-4 3.9 2.7 4.2 3.3 4.4 4.3 3.3 3.6
WK-8 3.1 3.3 2.9 3.1 3.0 2.7 2.5 2.6
Page 7 of 117
08/31/15.3
INTERNATIONAL RESEARCH SERVICES, INC.
SKIN CONDITION STUDY #3931OSM0415
EXPERT VISUAL GRADING
ELAS ACTINIC
EVAL TEX- FINE RADI EYELID TIC OVER CAPIL- KERA-
TIME TURE LINE ANCE LAXITY ITY ALL LARY TOSIS
------ ---- ---- ---- ------ ---- ---- ------ -------
** SUBJECT = 29
BASE 3.6 4.0 4.5 3.8 3.9 4.9 3.8
IMMED 3.0 3.5 4.2 4.0 3.7 5.0 3.6
WK-1 4.5 4.3 4.3 3.6 4.1 4.7 4.2
WK-4 3.7 3.7 3.8 3.2 3.5 3.9 3.7
WK-8 3.9 3.9 3.8 3.6 4.2 4.2 3.9
** SUBJECT = 30
BASE 3.6 2.9 4.7 3.1 3.9 5.0 3.1
IMMED 2.7 2.6 3.3 2.6 3.5 4.7 2.8
WK-1 5.2 4.0 5.0 2.4 3.7 4.9 3.6
WK-4 3.9 2.7 3.8 2.8 3.7 4.0 3.4
WK-8 3.0 2.8 2.1 2.9 3.2 3.0 2.9
** SUBJECT = 31
BASE 3.4 4.4 4.8 4.7 4.4 4.7 3.8
IMMED 2.7 4.1 3.7 3.9 3.7 4.1 3.5
WK-1 4.3 5.7 4.6 4.2 4.0 4.5 4.2
WK-4 4.0 4.6 4.4 3.7 4.0 4.2 3.1
WK-8 4.5 3.7 4.5 4.2 3.8 4.4 2.5
** SUBJECT = 32
BASE 3.2 4.6 4.7 4.2 3.7 4.8 4.2
IMMED 2.5 4.1 4.2 4.3 3.3 4.3 3.7
WK-1 4.4 5.5 5.0 4.7 4.0 5.0 4.2
WK-4 4.2 4.3 4.1 4.2 4.1 4.1 3.0
WK-8 2.8 4.2 3.3 4.0 3.6 4.2 2.3
** SUBJECT = 33
BASE 3.4 3.6 4.3 5.3 4.8 5.5 3.3 4.4
IMMED 2.6 3.3 3.2 5.3 3.7 5.1 3.1 3.9
WK-1 3.3 5.9 4.5 4.7 3.9 4.5 4.0 4.3
WK-4
WK-8 3.0 3.7 2.4 4.0 3.9 4.4 3.3 3.7
** SUBJECT = 35
BASE 2.9 3.5 4.9 3.2 3.5 5.1 4.7 4.5
IMMED 2.7 3.4 4.3 3.5 3.2 4.7 4.2 4.1
WK-1 4.6 3.7 4.7 3.3 3.8 4.8 4.9 5.1
WK-4 4.2 4.3 5.0 2.6 3.7 4.1 3.9 3.9
WK-8 3.5 3.8 4.2 2.6 3.5 3.5 3.7 3.1
** SUBJECT = 36
BASE 3.4 3.8 4.1 3.8 3.2 3.7 4.0 2.6
IMMED 3.0 3.5 3.6 4.1 3.6 3.2 3.4 2.6
WK-1 4.6 2.9 3.9 2.7 3.4 4.2 4.3 2.9
WK-4 4.2 3.7 3.8 2.6 3.6 4.2 4.4 2.8
WK-8 3.8 2.5 3.3 3.1 3.5 3.4 2.8 2.4
Page 8 of 117
08/31/15.3
INTERNATIONAL RESEARCH SERVICES, INC.
SKIN CONDITION STUDY #3931OSM0415
SIASCOPE
HEMO- HEMO- HEMO- HEMO- AVG.
EVAL GLOBIN GLOBIN GLOBIN GLOBIN HEMO
TIME MEAN 1 SD 1 MEAN 2 SD 2 GLOBIN
------ ------ ------ ------ ------ ------
** SUBJECT = 01
BASE 488.24 292.75 505.98 303.92 497.11
WK-1 633.90 310.00 670.10 325.20 652.00
WK-4 179.90 18.70 172.70 20.90 176.30
WK-8 159.80 16.90 159.70 19.20 159.75
** SUBJECT = 02
BASE 588.17 352.73 485.58 287.81 536.88
WK-1 614.60 339.10 614.60 282.20 614.60
WK-4 158.80 15.80 164.10 15.50 161.45
WK-8 159.80 17.30 157.90 19.20 158.85
** SUBJECT = 03
BASE 494.49 304.50 499.44 293.43 496.97
WK-1 553.80 314.40 565.70 301.70 559.75
WK-4 149.70 14.60 140.60 14.50 145.15
WK-8 140.80 14.10 155.30 14.30 148.05
** SUBJECT = 04
BASE 386.04 320.53 502.66 265.50 444.35
WK-1 527.93 345.00 507.60 346.40 517.76
WK-4 209.20 34.10 208.70 24.10 208.95
WK-8 231.40 15.50 231.40 15.50 231.40
** SUBJECT = 05
BASE 449.41 284.35 459.22 279.65 454.32
WK-1 488.80 309.10 521.20 286.80 505.00
WK-4 163.20 18.40 160.90 19.40 162.05
WK-8 176.10 24.30 178.20 23.10 177.15
** SUBJECT = 06
BASE 409.05 448.98 277.75 283.28 343.40
WK-1 521.20 305.00 507.60 311.70 514.40
WK-4 187.70 22.30 183.50 21.60 185.60
WK-8 166.40 20.60 155.90 21.10 161.15
** SUBJECT = 07
BASE 472.49 276.54 520.41 278.50 496.45
WK-1 555.50 309.30 474.70 342.60 515.10
WK-4 171.80 13.70 167.70 15.50 169.75
WK-8 176.90 24.30 165.10 24.10 171.00
** SUBJECT = 08
BASE 559.37 312.92 496.35 271.95 527.86
WK-1 671.90 323.90 595.10 354.00 633.50
WK-4 160.40 19.60 144.50 19.50 152.45
WK-8 138.50 17.80 131.00 18.00 134.75
Page 9 of 117
08/31/15.3
INTERNATIONAL RESEARCH SERVICES, INC.
SKIN CONDITION STUDY #3931OSM0415
SIASCOPE
HEMO- HEMO- HEMO- HEMO- AVG.
EVAL GLOBIN GLOBIN GLOBIN GLOBIN HEMO
TIME MEAN 1 SD 1 MEAN 2 SD 2 GLOBIN
------ ------ ------ ------ ------ ------
** SUBJECT = 09
BASE 404.60 311.43 407.25 321.50 405.93
WK-1 520.00 325.90 565.50 326.90 542.75
WK-4 138.30 14.10 120.10 12.10 129.20
WK-8 130.70 18.30 138.00 17.40 134.35
** SUBJECT = 10
BASE 552.46 312.29 449.38 308.34 500.92
WK-1 630.00 315.90 585.90 311.70 607.95
WK-4 152.80 15.90 147.50 13.10 150.15
WK-8 132.60 13.10 127.20 14.40 129.90
** SUBJECT = 12
BASE 468.09 331.51 405.47 311.40 436.78
WK-1 628.80 310.90 582.30 318.50 605.55
WK-4 136.70 15.70 130.00 12.70 133.35
WK-8 127.20 14.80 131.90 15.40 129.55
** SUBJECT = 13
BASE 496.72 297.04 544.52 295.99 520.62
WK-1 588.80 333.90 634.00 319.00 611.40
WK-4 154.90 16.50 122.40 14.50 138.65
WK-8 135.10 16.00 123.30 15.50 129.20
** SUBJECT = 14
BASE 428.17 307.88 469.03 340.26 448.60
WK-1 595.10 373.80 703.70 373.80 649.40
WK-4 167.20 17.80 145.00 15.90 156.10
WK-8 222.40 26.40 221.60 28.50 222.00
** SUBJECT = 15
BASE 473.22 317.97 397.57 291.02 435.39
WK-1 485.30 285.10 486.30 285.40 485.80
WK-4 158.40 15.20 164.90 16.80 161.65
WK-8 163.20 15.40 144.90 16.80 154.05
** SUBJECT = 16
BASE 447.74 364.39 367.93 275.03 407.84
WK-1 580.50 336.10 593.70 379.40 587.10
WK-4 200.50 21.40 175.10 23.70 187.80
WK-8 184.30 18.00 202.10 22.60 193.20
Page 10 of 117
08/31/15.3
INTERNATIONAL RESEARCH SERVICES, INC.
SKIN CONDITION STUDY #3931OSM0415
SIASCOPE
HEMO- HEMO- HEMO- HEMO- AVG.
EVAL GLOBIN GLOBIN GLOBIN GLOBIN HEMO
TIME MEAN 1 SD 1 MEAN 2 SD 2 GLOBIN
------ ------ ------ ------ ------ ------
** SUBJECT = 18
BASE 450.22 263.10 471.11 269.85 460.67
WK-1 567.50 339.70 601.20 300.20 584.35
WK-4 163.40 15.00 170.20 17.50 166.80
WK-8 153.30 15.20 153.40 15.30 153.35
** SUBJECT = 19
BASE 433.00 274.71 419.41 288.51 426.21
WK-1 513.60 321.20 620.70 324.70 567.15
WK-4 158.40 17.20 140.70 14.90 149.55
WK-8 188.60 15.50 160.80 18.40 174.70
** SUBJECT = 20
BASE 457.97 286.35 498.93 284.81 478.45
WK-1 562.90 316.80 574.40 318.00 568.65
WK-4 151.10 18.10 151.30 15.40 151.20
WK-8 150.50 12.50 145.00 23.40 147.75
** SUBJECT = 21
BASE 493.25 298.67 555.61 315.52 524.43
WK-1 603.70 338.30 629.40 364.00 616.55
WK-4 185.70 17.90 209.20 28.50 197.45
WK-8 217.30 28.30 209.00 26.60 213.15
** SUBJECT = 22
BASE 459.52 296.96 434.26 285.34 446.89
WK-1 628.70 312.80 582.20 319.00 605.45
WK-4 151.30 15.50 161.80 16.40 156.55
WK-8 166.70 15.90 143.50 16.00 155.10
** SUBJECT = 23
BASE 466.94 269.12 486.94 280.72 476.94
WK-1 582.80 325.80 567.60 325.50 575.20
WK-4 178.80 17.20 176.00 17.30 177.40
WK-8 159.40 18.50 150.20 14.30 154.80
** SUBJECT = 24
BASE 524.64 299.39 398.51 303.94 461.57
WK-1 459.20 352.90 599.00 370.20 529.10
WK-4 215.40 30.50 202.80 32.30 209.10
WK-8 181.00 29.20 197.60 30.10 189.30
** SUBJECT = 25
BASE 494.84 304.45 464.02 316.44 479.43
WK-1 584.00 366.30 636.00 331.10 610.00
WK-4 215.00 29.50 210.40 31.60 212.70
WK-8 208.20 20.30 219.80 39.60 214.00
Page 11 of 117
08/31/15.3
INTERNATIONAL RESEARCH SERVICES, INC.
SKIN CONDITION STUDY #3931OSM0415
SIASCOPE
HEMO- HEMO- HEMO- HEMO- AVG.
EVAL GLOBIN GLOBIN GLOBIN GLOBIN HEMO
TIME MEAN 1 SD 1 MEAN 2 SD 2 GLOBIN
------ ------ ------ ------ ------ ------
** SUBJECT = 26
BASE 491.14 287.53 492.00 316.13 491.57
WK-1 596.90 336.00 639.10 317.30 618.00
WK-4 151.10 18.90 169.10 21.10 160.10
WK-8 139.00 30.00 165.60 24.30 152.30
** SUBJECT = 27
BASE 504.14 282.54 459.53 264.34 481.83
WK-1 596.60 311.70 562.30 341.10 579.45
WK-4 177.50 22.00 172.10 18.70 174.80
WK-8 150.00 13.30 154.90 17.20 152.45
** SUBJECT = 28
BASE 368.20 352.56 386.89 326.47 377.54
WK-1 564.70 371.30 567.40 351.10 566.05
WK-4 199.50 19.40 195.20 19.30 197.35
WK-8 199.60 17.30 199.60 17.30 199.60
** SUBJECT = 29
BASE 481.55 281.50 485.51 301.78 483.53
WK-1 481.30 307.30 570.20 319.90 525.75
WK-4 162.80 16.70 176.00 16.40 169.40
WK-8 152.80 15.70 157.20 16.00 155.00
** SUBJECT = 30
BASE 515.71 351.08 455.94 343.83 485.83
WK-1 556.40 354.00 568.00 339.70 562.20
WK-4 200.90 21.80 183.30 23.50 192.10
WK-8 215.20 21.80 205.50 20.40 210.35
** SUBJECT = 31
BASE 472.31 287.95 458.46 280.81 465.38
WK-1 578.80 343.30 575.60 330.90 577.20
WK-4 138.50 14.30 136.40 14.30 137.45
WK-8 161.80 14.20 151.80 14.10 156.80
** SUBJECT = 32
BASE 558.01 296.28 473.24 285.85 515.62
WK-1 536.90 338.20 545.60 340.40 541.25
WK-4 181.20 18.90 175.50 18.40 178.35
WK-8 167.80 16.30 171.80 19.10 169.80
** SUBJECT = 33
BASE 507.32 335.02 539.37 326.24 523.35
WK-1 599.10 314.60 616.10 325.80 607.60
WK-4
WK-8 130.40 14.90 130.00 15.10 130.20
Page 12 of 117
08/31/15.3
INTERNATIONAL RESEARCH SERVICES, INC.
SKIN CONDITION STUDY #3931OSM0415
SIASCOPE
HEMO- HEMO- HEMO- HEMO- AVG.
EVAL GLOBIN GLOBIN GLOBIN GLOBIN HEMO
TIME MEAN 1 SD 1 MEAN 2 SD 2 GLOBIN
------ ------ ------ ------ ------ ------
** SUBJECT = 35
BASE 499.44 306.88 467.49 330.68 483.47
WK-1 711.90 225.10 699.70 223.90 705.80
WK-4 154.50 22.10 152.50 25.90 153.50
WK-8 133.30 20.40 128.80 14.60 131.05
** SUBJECT = 36
BASE 521.95 300.29 530.88 329.95 526.41
WK-1 241.40 18.10 275.60 23.50 258.50
WK-4 207.50 19.40 216.60 16.80 212.05
WK-8 188.50 14.00 192.30 15.40 190.40
Page 13 of 117
08/31/15.3
INTERNATIONAL RESEARCH SERVICES, INC.
SKIN CONDITION STUDY #3931OSM0415
QUESTIONNAIRE
EVAL
TIME Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 Q10 Q11 Q12 Q13
------ -- -- -- -- -- -- -- -- -- --- --- --- ---
** SUBJECT = 01
IMMED 3 3 4 4 4 4 3 3 3 3 3 2 6
WK-1 3 3 2 2 3 2 2 3 3 3 2 2 6
WK-4 2 3 2 3 2 2 3 3 2 3 2 1 6
WK-8 2 3 2 3 2 2 2 3 2 3 2 1 6
** SUBJECT = 02
IMMED 3 2 2 2 2 2 3 3 3 3 2 2 3
WK-1 3 2 2 2 3 2 3 2 2 2 2 2 2
WK-4 2 2 2 2 2 2 2 2 2 2 2 2
WK-8 2 2 2 2 2 2 2 2 2 2 2 2
** SUBJECT = 03
IMMED 3 3 2 2 2 3 3 2 1 1 1 1 6
WK-1 3 3 2 2 4 3 3 3 1 2 1 1 6
WK-4 1 3 2 2 3 2 1 1 1 1 1 1 6
WK-8 3 2 2 2 2 2 1 1 1 2 1 1 6
** SUBJECT = 04
IMMED 3 2 2 2 3 2 3 3 2 2 2 1 6
WK-1 3 3 2 2 3 2 3 3 2 2 2 1 6
WK-4 3 3 2 2 3 2 3 3 2 2 2 1 6
WK-8 2 2 2 3 3 2 3 3 1 2 2 1 6
** SUBJECT = 05
IMMED 3 3 3 2 2 2 3 3 4 4 3 1 6
WK-1 4 2 2 2 2 2 4 4 4 4 4 2 6
WK-4 4 4 2 2 2 2 4 4 4 3 3 1 6
WK-8 4 2 2 2 2 2 4 4 3 3 3 1 6
** SUBJECT = 06
IMMED 3 3 2 2 2 2 3 3 2 2 2 3 6
WK-1 4 3 2 2 2 2 3 3 2 2 2 3 6
WK-4 3 3 5 2 2 2 3 3 2 2 2 2 6
WK-8 3 2 2 2 2 3 2 2 2 2 2 2 6
** SUBJECT = 07
IMMED 3 1 1 1 1 1 1 2 3 3 2 1 6
WK-1 2 2 2 2 2 2 2 2 3 3 2 1 6
WK-4 3 2 2 2 2 2 2 2 2 2 2 2 6
WK-8 2 2 1 2 1 1 1 1 2 2 2 1 6
** SUBJECT = 08
IMMED 3 3 2 2 2 2 3 3 3 3 3 3 6
WK-1 3 4 2 3 3 3 3 3 2 2 3 2 6
WK-4 3 3 2 3 3 3 2 2 2 2 2 2 6
WK-8 3 4 4 3 3 3 3 3 2 2 3 3 6
Page 14 of 117
08/31/15.3
INTERNATIONAL RESEARCH SERVICES, INC.
SKIN CONDITION STUDY #3931OSM0415
QUESTIONNAIRE
EVAL
TIME Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 Q10 Q11 Q12 Q13
------ -- -- -- -- -- -- -- -- -- --- --- --- ---
** SUBJECT = 09
IMMED 2 3 3 2 3 2 2 3 2 2 2 2 2
WK-1 3 2 2 3 3 3 3 3 2 2 2 2 2
WK-4 3 3 2 3 2 3 3 3 2 2 2 2 2
WK-8 2 3 3 3 3 2 3 3 2 2 2 2 3
** SUBJECT = 10
IMMED 3 3 2 2 2 2 3 3 3 3 3 1 6
WK-1 3 2 2 2 2 2 3 3 3 3 3 1 6
WK-4 3 3 2 3 3 2 3 3 3 3 3 2 6
WK-8 3 2 2 3 3 2 3 3 2 3 3 2 6
** SUBJECT = 12
IMMED 2 2 1 1 1 1 3 3 2 2 2 1 6
WK-1 1 2 1 1 1 1 2 1 1 2 1 1 6
WK-4 1 1 1 1 2 1 1 2 1 2 1 1 6
WK-8 1 1 1 2 1 1 2 2 2 1 1 1 6
** SUBJECT = 13
IMMED 1 3 1 1 1 1 1 1 2 1 1 1 6
WK-1 1 2 1 1 1 1 1 1 1 1 1 1 6
WK-4 1 1 1 1 1 1 1 1 1 1 1 1 6
WK-8 1 2 1 1 1 1 1 1 1 1 1 1 6
** SUBJECT = 14
IMMED 3 3 3 3 3 3 3 3 3 3 3 3 3
WK-1 3 3 3 3 3 3 3 3 3 3 3 2 3
WK-4 3 3 3 3 3 3 3 3 3 3 3 3 3
WK-8 3 3 3 3 3 3 3 3 3 3 3 3 3
** SUBJECT = 15
IMMED 3 3 3 3 3 3 3 3 3 3 3 3 3
WK-1 3 3 3 3 3 3 3 3 3 3 3 3 3
WK-4 3 3 3 3 3 3 3 3 3 3 3 3 3
WK-8 3 3 3 3 3 3 3 3 3 3 3 3 3
** SUBJECT = 16
IMMED 3 3 2 2 2 2 3 3 2 2 2 1 6
WK-1 2 2 2 2 2 2 2 2 2 2 2 1 6
WK-4 1 1 1 1 1 1 1 1 1 1 1 1 6
WK-8 1 1 1 1 1 1 1 1 1 1 1 1 6
Page 15 of 117
08/31/15.3
INTERNATIONAL RESEARCH SERVICES, INC.
SKIN CONDITION STUDY #3931OSM0415
QUESTIONNAIRE
EVAL
TIME Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 Q10 Q11 Q12 Q13
------ -- -- -- -- -- -- -- -- -- --- --- --- ---
** SUBJECT = 18
IMMED 3 2 2 2 2 2 2 2 2 2 2 2 2
WK-1 3 3 2 2 2 2 2 2 2 2 2 2 2
WK-4 2 2 2 2 2 2 2 2 2 2 2 1 2
WK-8 2 2 2 2 2 2 2 2 2 2 2 1 4
** SUBJECT = 19
IMMED 3 2 2 2 3 3 3 3 3 3 3 1 6
WK-1 2 2 2 2 2 2 2 2 2 2 2 1 6
WK-4 2 2 2 2 2 2 2 2 1 1 1 1 6
WK-8 1 1 1 1 1 1 1 1 1 1 1 1 6
** SUBJECT = 20
IMMED 3 2 2 2 2 3 3 3 2 2 2 1 6
WK-1 2 3 2 2 2 3 2 2 2 2 2 1 6
WK-4 3 2 2 2 3 2 3 3 2 2 2 2 6
WK-8 2 2 2 2 3 2 2 2 2 2 2 2 6
** SUBJECT = 21
IMMED 3 3 3 3 3 3 3 3 3 3 3 1 6
WK-1 2 3 2 2 2 2 2 2 2 2 2 1 6
WK-4 2 3 3 3 3 3 2 2 2 3 2 2 6
WK-8 2 3 2 2 3 2 2 2 2 2 2 1 6
** SUBJECT = 22
IMMED 2 2 2 2 2 2 2 2 2 2 2 2 6
WK-1 2 2 2 2 2 2 2 2 2 2 2 2 6
WK-4 2 2 2 1 1 1 2 2 2 2 2 1 6
WK-8 1 1 1 1 2 1 2 1 2 2 2 1 6
** SUBJECT = 23
IMMED 3 3 1 1 2 2 3 3 2 2 3 1 1
WK-1 2 2 1 1 1 1 2 2 1 1 1 1 1
WK-4 1 1 1 1 1 1 1 1 1 1 1 1 1
WK-8 1 2 1 1 1 1 1 2 1 1 1 1 1
** SUBJECT = 24
IMMED 5 5 5 5 5 5 5 5 5 5 5 5 6
WK-1 5 5 5 5 5 5 5 5 5 5 5 2 6
WK-4 4 4 4 4 4 4 4 4 4 4 4 4 6
WK-8 4 4 4 4 4 4 4 4 4 4 4 2 6
** SUBJECT = 25
IMMED 2 3 2 3 3 2 3 3 2 3 3 2 3
WK-1 2 3 3 3 3 2 2 2 3 3 3 1 2
WK-4 2 3 3 2 2 2 3 3 3 3 2 2 3
WK-8 2 3 2 2 3 2 3 3 2 2 2 2 2
Page 16 of 117
08/31/15.3
INTERNATIONAL RESEARCH SERVICES, INC.
SKIN CONDITION STUDY #3931OSM0415
QUESTIONNAIRE
EVAL
TIME Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 Q10 Q11 Q12 Q13
------ -- -- -- -- -- -- -- -- -- --- --- --- ---
** SUBJECT = 26
IMMED 3 3 3 3 3 3 3 3 3 3 3 3 6
WK-1 2 3 3 3 2 3 3 3 2 2 2 2 6
WK-4 4 2 3 2 3 3 3 2 2 3 3 2 6
WK-8 3 2 2 2 2 3 3 3 1 1 2 1 6
** SUBJECT = 27
IMMED 2 2 3 2 2 2 2 3 2 2 2 2 2
WK-1 2 2 2 2 2 3 2 2 2 2 2 1 1
WK-4 2 2 3 2 3 3 3 2 2 2 2 2 2
WK-8 1 2 1 2 2 1 2 2 1 1 1 1 1
** SUBJECT = 28
IMMED 3 3 3 3 3 3 3 3 3 3 3 2 3
WK-1 3 3 3 3 3 3 3 3 2 3 3 2 3
WK-4 3 3 2 2 3 2 3 3 2 2 2 2 3
WK-8 3 2 2 2 3 2 3 3 2 2 2 1 2
** SUBJECT = 29
IMMED 3 3 3 3 3 2 3 3 3 3 3 2 6
WK-1 3 3 3 3 3 3 3 3 2 2 2 2 6
WK-4 3 2 2 2 3 2 3 3 2 2 2 2 6
WK-8 3 2 2 2 3 2 3 3 2 2 2 1 6
** SUBJECT = 30
IMMED 3 3 3 2 3 2 3 3 2 2 2 2 3
WK-1 3 3 3 3 3 3 3 3 2 2 2 2 3
WK-4 3 3 2 2 3 3 3 3 2 2 2 2 3
WK-8 2 3 2 2 3 3 2 3 2 2 2 2 3
** SUBJECT = 31
IMMED 5 5 3 3 3 2 5 5 2 3 4 4 6
WK-1 3 3 3 3 3 3 3 3 3 3 3 2 6
WK-4 3 3 3 2 3 2 3 3 3 3 2 2 6
WK-8 3 3 2 2 3 2 3 3 3 3 3 1 6
** SUBJECT = 32
IMMED 3 3 3 2 3 2 3 3 3 3 3 2 3
WK-1 3 3 2 3 3 2 3 3 3 3 3 2 3
WK-4 3 3 2 2 2 2 3 3 3 3 2 1 2
WK-8 3 3 2 3 2 2 2 2 3 3 2 2 2
** SUBJECT = 33
IMMED 3 3 2 3 3 2 3 3 2 3 3 1 3
WK-1 2 3 2 2 3 3 3 3 3 3 3 1 3
WK-4
WK-8 2 3 3 3 2 3 3 3 2 3 2 1 3
Page 17 of 117
08/31/15.3
INTERNATIONAL RESEARCH SERVICES, INC.
SKIN CONDITION STUDY #3931OSM0415
QUESTIONNAIRE
EVAL
TIME Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 Q10 Q11 Q12 Q13
------ -- -- -- -- -- -- -- -- -- --- --- --- ---
** SUBJECT = 35
IMMED 4 4 3 3 3 2 4 4 4 4 4 3 4
WK-1 4 4 3 4 4 3 4 4 3 4 4 1 4
WK-4 4 4 4 4 4 4 4 4 3 3 3 1 4
WK-8 3 4 3 3 3 2 3 3 2 2 3 1 3
** SUBJECT = 36
IMMED 3 3 3 3 3 3 3 3 2 2 2 3 3
WK-1 3 3 2 2 3 2 2 2 2 2 2 1 1
WK-4 2 3 2 2 2 2 3 2 2 2 2 3 3
WK-8 1 3 1 2 2 2 2 2 1 2 2 1 2
Page 18 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/25/15.1
MEDICAL HISTORY
HGT SUBJECTS HEIGHT
Valid Cum
Value Label Value Frequency Percent Percent Percent
59.0 1 3.0 3.0 3.0
60.0 3 9.1 9.1 12.1
61.0 2 6.1 6.1 18.2
62.0 2 6.1 6.1 24.2
63.0 5 15.2 15.2 39.4
63.5 1 3.0 3.0 42.4
64.0 5 15.2 15.2 57.6
64.5 1 3.0 3.0 60.6
65.0 4 12.1 12.1 72.7
66.0 1 3.0 3.0 75.8
67.0 3 9.1 9.1 84.8
68.0 2 6.1 6.1 90.9
69.0 3 9.1 9.1 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 64.182 Std Err .482 Median 64.000
Std Dev 2.769 Variance 7.669
Valid Cases 33 Missing Cases 0
Page 19 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/25/15.1
MEDICAL HISTORY
WGT SUBJECTS WEIGHT
Valid Cum
Value Label Value Frequency Percent Percent Percent
96 1 3.0 3.0 3.0
103 2 6.1 6.1 9.1
112 1 3.0 3.0 12.1
130 3 9.1 9.1 21.2
135 1 3.0 3.0 24.2
140 2 6.1 6.1 30.3
148 1 3.0 3.0 33.3
150 4 12.1 12.1 45.5
160 1 3.0 3.0 48.5
165 1 3.0 3.0 51.5
169 1 3.0 3.0 54.5
170 1 3.0 3.0 57.6
173 1 3.0 3.0 60.6
178 1 3.0 3.0 63.6
180 1 3.0 3.0 66.7
190 3 9.1 9.1 75.8
200 4 12.1 12.1 87.9
216 1 3.0 3.0 90.9
220 1 3.0 3.0 93.9
240 1 3.0 3.0 97.0
300 1 3.0 3.0 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 166.909 Std Err 7.470 Median 165.000
Std Dev 42.912 Variance 1841.460
Valid Cases 33 Missing Cases 0
Page 20 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/25/15.1
MEDICAL HISTORY
AGE SUBJECTS AGE
Valid Cum
Value Label Value Frequency Percent Percent Percent
35 1 3.0 3.0 3.0
37 1 3.0 3.0 6.1
38 1 3.0 3.0 9.1
43 1 3.0 3.0 12.1
45 1 3.0 3.0 15.2
46 1 3.0 3.0 18.2
47 1 3.0 3.0 21.2
48 3 9.1 9.1 30.3
49 4 12.1 12.1 42.4
50 1 3.0 3.0 45.5
52 3 9.1 9.1 54.5
54 1 3.0 3.0 57.6
55 1 3.0 3.0 60.6
56 2 6.1 6.1 66.7
57 2 6.1 6.1 72.7
58 4 12.1 12.1 84.8
59 4 12.1 12.1 97.0
60 1 3.0 3.0 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 51.515 Std Err 1.184 Median 52.000
Std Dev 6.801 Variance 46.258
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
ETHN SUBJECTS ETHNICITY
Valid Cum
Value Label Value Frequency Percent Percent Percent
HISPANIC 1.00 6 18.2 18.2 18.2
NON-HISPANIC 2.00 27 81.8 81.8 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
Page 21 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/25/15.1
MEDICAL HISTORY
RACE SUBJECTS RACE
Valid Cum
Value Label Value Frequency Percent Percent Percent
WHITE 1.00 27 81.8 96.4 96.4
BLACK 2.00 1 3.0 3.6 100.0
. 5 15.2 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 28 Missing Cases 5
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
FACE SUBJECTS FACIAL SKIN
Valid Cum
Value Label Value Frequency Percent Percent Percent
DRY 1.00 3 9.1 9.1 9.1
OILY 2.00 1 3.0 3.0 12.1
NORMAL 3.00 14 42.4 42.4 54.5
COMBO 4.00 15 45.5 45.5 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
BODY SUBJECTS BODY SKIN
Valid Cum
Value Label Value Frequency Percent Percent Percent
NORMAL 1.00 25 75.8 75.8 75.8
DRY 2.00 8 24.2 24.2 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
Page 22 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/25/15.1
MEDICAL HISTORY
FITZ SUBJECTS FITZPATRICK SCORE
Valid Cum
Value Label Value Frequency Percent Percent Percent
1 1 3.0 3.0 3.0
2 10 30.3 30.3 33.3
3 15 45.5 45.5 78.8
4 6 18.2 18.2 97.0
5 1 3.0 3.0 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.879 Std Err .149 Median 3.000
Std Dev .857 Variance .735
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
SKIN SUBJECT HAS SENSITIVE SKIN
Valid Cum
Value Label Value Frequency Percent Percent Percent
YES 1.00 4 12.1 12.1 12.1
NO 2.00 29 87.9 87.9 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
EYES SUBJECT HAS SENSITIVE EYES
Valid Cum
Value Label Value Frequency Percent Percent Percent
YES 1.00 5 15.2 15.2 15.2
NO 2.00 28 84.8 84.8 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
Page 23 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/25/15.1
MEDICAL HISTORY
LENS SUBJECT WEARS CONTACTS
Valid Cum
Value Label Value Frequency Percent Percent Percent
YES 1.00 6 18.2 18.2 18.2
NO 2.00 27 81.8 81.8 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
OCCU SUBJECTS OCCUPATION
Valid Cum
Value Label Value Frequency Percent Percent Percent
RETIRED 2.00 5 15.2 15.2 15.2
HOMEMAKER 3.00 10 30.3 30.3 45.5
UNEMPLOYED 4.00 5 15.2 15.2 60.6
EMPLOYED 5.00 13 39.4 39.4 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
Page 24 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Paired samples t-test: TEXT0 BASE TEXTURE/SMOOTHNESS
TEXT1 IMMED TEXTURE/SMOOTHNESS
Variable Number Standard Standard
of Cases Mean Deviation Error
TEXT0 33 4.0515 .491 .086
TEXT1 33 3.0788 .550 .096
(Difference) Standard Standard | 2-Tail | t Degrees of 2-Tail
Mean Deviation Error | Corr. Prob. | Value Freedom Prob.
| |
.9727 .526 .092 | .495 .003 | 10.63 32 .000
Paired samples t-test: TEXT0 BASE TEXTURE/SMOOTHNESS
TEXT2 WK-1 TEXTURE/SMOOTHNESS
Variable Number Standard Standard
of Cases Mean Deviation Error
TEXT0 33 4.0515 .491 .086
TEXT2 33 4.2727 .446 .078
(Difference) Standard Standard | 2-Tail | t Degrees of 2-Tail
Mean Deviation Error | Corr. Prob. | Value Freedom Prob.
| |
-.2212 .676 .118 | -.039 .829 | -1.88 32 .069
Paired samples t-test: TEXT0 BASE TEXTURE/SMOOTHNESS
TEXT4 WK-4 TEXTURE/SMOOTHNESS
Variable Number Standard Standard
of Cases Mean Deviation Error
TEXT0 32 4.0719 .485 .086
TEXT4 32 4.1219 .276 .049
(Difference) Standard Standard | 2-Tail | t Degrees of 2-Tail
Mean Deviation Error | Corr. Prob. | Value Freedom Prob.
| |
-.0500 .502 .089 | .220 .227 | -.56 31 .577
Page 25 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Paired samples t-test: TEXT0 BASE TEXTURE/SMOOTHNESS
TEXT8 WK-8 TEXTURE/SMOOTHNESS
Variable Number Standard Standard
of Cases Mean Deviation Error
TEXT0 33 4.0515 .491 .086
TEXT8 33 3.5939 .490 .085
(Difference) Standard Standard | 2-Tail | t Degrees of 2-Tail
Mean Deviation Error | Corr. Prob. | Value Freedom Prob.
| |
.4576 .639 .111 | .153 .395 | 4.11 32 .000
Paired samples t-test: LINE0 BASE FINE LINES (CROWS FEET)
LINE1 IMMED FINE LINES (CROWS FEET)
Variable Number Standard Standard
of Cases Mean Deviation Error
LINE0 33 4.2000 .860 .150
LINE1 33 3.7152 .776 .135
(Difference) Standard Standard | 2-Tail | t Degrees of 2-Tail
Mean Deviation Error | Corr. Prob. | Value Freedom Prob.
| |
.4848 .203 .035 | .974 .000 | 13.70 32 .000
Paired samples t-test: LINE0 BASE FINE LINES (CROWS FEET)
LINE2 WK-1 FINE LINES (CROWS FEET)
Variable Number Standard Standard
of Cases Mean Deviation Error
LINE0 33 4.2000 .860 .150
LINE2 33 4.6697 .982 .171
(Difference) Standard Standard | 2-Tail | t Degrees of 2-Tail
Mean Deviation Error | Corr. Prob. | Value Freedom Prob.
| |
-.4697 .803 .140 | .627 .000 | -3.36 32 .002
Page 26 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Paired samples t-test: LINE0 BASE FINE LINES (CROWS FEET)
LINE4 WK-4 FINE LINES (CROWS FEET)
Variable Number Standard Standard
of Cases Mean Deviation Error
LINE0 32 4.2188 .867 .153
LINE4 32 4.0031 .824 .146
(Difference) Standard Standard | 2-Tail | t Degrees of 2-Tail
Mean Deviation Error | Corr. Prob. | Value Freedom Prob.
| |
.2156 .655 .116 | .701 .000 | 1.86 31 .072
Paired samples t-test: LINE0 BASE FINE LINES (CROWS FEET)
LINE8 WK-8 FINE LINES (CROWS FEET)
Variable Number Standard Standard
of Cases Mean Deviation Error
LINE0 33 4.2000 .860 .150
LINE8 33 3.4818 .783 .136
(Difference) Standard Standard | 2-Tail | t Degrees of 2-Tail
Mean Deviation Error | Corr. Prob. | Value Freedom Prob.
| |
.7182 .622 .108 | .717 .000 | 6.64 32 .000
Paired samples t-test: RADI0 BASE RADIANCE
RADI1 IMMED RADIANCE
Variable Number Standard Standard
of Cases Mean Deviation Error
RADI0 33 4.7303 .423 .074
RADI1 33 3.2000 .598 .104
(Difference) Standard Standard | 2-Tail | t Degrees of 2-Tail
Mean Deviation Error | Corr. Prob. | Value Freedom Prob.
| |
1.5303 .810 .141 | -.235 .189 | 10.86 32 .000
Page 27 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Paired samples t-test: RADI0 BASE RADIANCE
RADI2 WK-1 RADIANCE
Variable Number Standard Standard
of Cases Mean Deviation Error
RADI0 33 4.7303 .423 .074
RADI2 33 4.6636 .578 .101
(Difference) Standard Standard | 2-Tail | t Degrees of 2-Tail
Mean Deviation Error | Corr. Prob. | Value Freedom Prob.
| |
.0667 .469 .082 | .600 .000 | .82 32 .420
Paired samples t-test: RADI0 BASE RADIANCE
RADI4 WK-4 RADIANCE
Variable Number Standard Standard
of Cases Mean Deviation Error
RADI0 32 4.7437 .423 .075
RADI4 32 4.2094 .386 .068
(Difference) Standard Standard | 2-Tail | t Degrees of 2-Tail
Mean Deviation Error | Corr. Prob. | Value Freedom Prob.
| |
.5344 .431 .076 | .435 .013 | 7.02 31 .000
Paired samples t-test: RADI0 BASE RADIANCE
RADI8 WK-8 RADIANCE
Variable Number Standard Standard
of Cases Mean Deviation Error
RADI0 33 4.7303 .423 .074
RADI8 33 3.2030 .727 .127
(Difference) Standard Standard | 2-Tail | t Degrees of 2-Tail
Mean Deviation Error | Corr. Prob. | Value Freedom Prob.
| |
1.5273 .765 .133 | .199 .267 | 11.47 32 .000
Page 28 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Paired samples t-test: LAXI0 BASE EYELID LAXITY
LAXI1 IMMED EYELID LAXITY
Variable Number Standard Standard
of Cases Mean Deviation Error
LAXI0 33 3.8606 .905 .158
LAXI1 33 3.6697 .853 .149
(Difference) Standard Standard | 2-Tail | t Degrees of 2-Tail
Mean Deviation Error | Corr. Prob. | Value Freedom Prob.
| |
.1909 .285 .050 | .949 .000 | 3.84 32 .001
Paired samples t-test: LAXI0 BASE EYELID LAXITY
LAXI2 WK-1 EYELID LAXITY
Variable Number Standard Standard
of Cases Mean Deviation Error
LAXI0 33 3.8606 .905 .158
LAXI2 33 3.7818 .797 .139
(Difference) Standard Standard | 2-Tail | t Degrees of 2-Tail
Mean Deviation Error | Corr. Prob. | Value Freedom Prob.
| |
.0788 .766 .133 | .601 .000 | .59 32 .559
Paired samples t-test: LAXI0 BASE EYELID LAXITY
LAXI4 WK-4 EYELID LAXITY
Variable Number Standard Standard
of Cases Mean Deviation Error
LAXI0 32 3.8156 .881 .156
LAXI4 32 3.5000 .590 .104
(Difference) Standard Standard | 2-Tail | t Degrees of 2-Tail
Mean Deviation Error | Corr. Prob. | Value Freedom Prob.
| |
.3156 .645 .114 | .681 .000 | 2.77 31 .009
Page 29 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Paired samples t-test: LAXI0 BASE EYELID LAXITY
LAXI8 WK-8 EYELID LAXITY
Variable Number Standard Standard
of Cases Mean Deviation Error
LAXI0 33 3.8606 .905 .158
LAXI8 33 3.2333 .610 .106
(Difference) Standard Standard | 2-Tail | t Degrees of 2-Tail
Mean Deviation Error | Corr. Prob. | Value Freedom Prob.
| |
.6273 .643 .112 | .704 .000 | 5.61 32 .000
Paired samples t-test: ELAS0 BASE ELASTICITY
ELAS1 IMMED ELASTICITY
Variable Number Standard Standard
of Cases Mean Deviation Error
ELAS0 33 3.9061 .362 .063
ELAS1 33 3.4667 .359 .063
(Difference) Standard Standard | 2-Tail | t Degrees of 2-Tail
Mean Deviation Error | Corr. Prob. | Value Freedom Prob.
| |
.4394 .335 .058 | .568 .001 | 7.53 32 .000
Paired samples t-test: ELAS0 BASE ELASTICITY
ELAS2 WK-1 ELASTICITY
Variable Number Standard Standard
of Cases Mean Deviation Error
ELAS0 33 3.9061 .362 .063
ELAS2 33 3.8939 .376 .065
(Difference) Standard Standard | 2-Tail | t Degrees of 2-Tail
Mean Deviation Error | Corr. Prob. | Value Freedom Prob.
| |
.0121 .397 .069 | .420 .015 | .18 32 .862
Page 30 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Paired samples t-test: ELAS0 BASE ELASTICITY
ELAS4 WK-4 ELASTICITY
Variable Number Standard Standard
of Cases Mean Deviation Error
ELAS0 32 3.8781 .330 .058
ELAS4 32 3.9750 .278 .049
(Difference) Standard Standard | 2-Tail | t Degrees of 2-Tail
Mean Deviation Error | Corr. Prob. | Value Freedom Prob.
| |
-.0969 .374 .066 | .254 .161 | -1.47 31 .153
Paired samples t-test: ELAS0 BASE ELASTICITY
ELAS8 WK-8 ELASTICITY
Variable Number Standard Standard
of Cases Mean Deviation Error
ELAS0 33 3.9061 .362 .063
ELAS8 33 3.5061 .352 .061
(Difference) Standard Standard | 2-Tail | t Degrees of 2-Tail
Mean Deviation Error | Corr. Prob. | Value Freedom Prob.
| |
.4000 .405 .070 | .358 .041 | 5.68 32 .000
Paired samples t-test: OVER0 BASE OVERALL APPEARANCE
OVER1 IMMED OVERALL APPEARANCE
Variable Number Standard Standard
of Cases Mean Deviation Error
OVER0 33 4.8091 .386 .067
OVER1 33 4.2576 .575 .100
(Difference) Standard Standard | 2-Tail | t Degrees of 2-Tail
Mean Deviation Error | Corr. Prob. | Value Freedom Prob.
| |
.5515 .451 .078 | .623 .000 | 7.03 32 .000
Page 31 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Paired samples t-test: OVER0 BASE OVERALL APPEARANCE
OVER2 WK-1 OVERALL APPEARANCE
Variable Number Standard Standard
of Cases Mean Deviation Error
OVER0 33 4.8091 .386 .067
OVER2 33 4.6152 .355 .062
(Difference) Standard Standard | 2-Tail | t Degrees of 2-Tail
Mean Deviation Error | Corr. Prob. | Value Freedom Prob.
| |
.1939 .390 .068 | .447 .009 | 2.85 32 .008
Paired samples t-test: OVER0 BASE OVERALL APPEARANCE
OVER4 WK-4 OVERALL APPEARANCE
Variable Number Standard Standard
of Cases Mean Deviation Error
OVER0 32 4.7875 .371 .066
OVER4 32 4.3375 .350 .062
(Difference) Standard Standard | 2-Tail | t Degrees of 2-Tail
Mean Deviation Error | Corr. Prob. | Value Freedom Prob.
| |
.4500 .461 .081 | .185 .311 | 5.53 31 .000
Paired samples t-test: OVER0 BASE OVERALL APPEARANCE
OVER8 WK-8 OVERALL APPEARANCE
Variable Number Standard Standard
of Cases Mean Deviation Error
OVER0 33 4.8091 .386 .067
OVER8 33 3.8030 .516 .090
(Difference) Standard Standard | 2-Tail | t Degrees of 2-Tail
Mean Deviation Error | Corr. Prob. | Value Freedom Prob.
| |
1.0061 .430 .075 | .579 .000 | 13.44 32 .000
Page 32 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Paired samples t-test: CAPL0 BASE CAPILLARY VISIBILITY
CAPL1 IMMED CAPILLARY VISIBILITY
Variable Number Standard Standard
of Cases Mean Deviation Error
CAPL0 19 4.3895 .681 .156
CAPL1 19 4.1474 .711 .163
(Difference) Standard Standard | 2-Tail | t Degrees of 2-Tail
Mean Deviation Error | Corr. Prob. | Value Freedom Prob.
| |
.2421 .257 .059 | .933 .000 | 4.11 18 .001
Paired samples t-test: CAPL0 BASE CAPILLARY VISIBILITY
CAPL2 WK-1 CAPILLARY VISIBILITY
Variable Number Standard Standard
of Cases Mean Deviation Error
CAPL0 19 4.3895 .681 .156
CAPL2 19 4.3789 .654 .150
(Difference) Standard Standard | 2-Tail | t Degrees of 2-Tail
Mean Deviation Error | Corr. Prob. | Value Freedom Prob.
| |
.0105 .386 .088 | .834 .000 | .12 18 .907
Paired samples t-test: CAPL0 BASE CAPILLARY VISIBILITY
CAPL4 WK-4 CAPILLARY VISIBILITY
Variable Number Standard Standard
of Cases Mean Deviation Error
CAPL0 18 4.4500 .646 .152
CAPL4 18 3.9278 .573 .135
(Difference) Standard Standard | 2-Tail | t Degrees of 2-Tail
Mean Deviation Error | Corr. Prob. | Value Freedom Prob.
| |
.5222 .467 .110 | .712 .001 | 4.74 17 .000
Page 33 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Paired samples t-test: CAPL0 BASE CAPILLARY VISIBILITY
CAPL8 WK-8 CAPILLARY VISIBILITY
Variable Number Standard Standard
of Cases Mean Deviation Error
CAPL0 19 4.3895 .681 .156
CAPL8 19 3.2632 .618 .142
(Difference) Standard Standard | 2-Tail | t Degrees of 2-Tail
Mean Deviation Error | Corr. Prob. | Value Freedom Prob.
| |
1.1263 .558 .128 | .635 .004 | 8.80 18 .000
Paired samples t-test: ACTN0 BASE ACTINIC KERATOSIS SEVERITY
ACTN1 IMMED ACTINIC KERATOSIS SEVERITY
Variable Number Standard Standard
of Cases Mean Deviation Error
ACTN0 14 3.5929 .664 .177
ACTN1 14 3.2857 .589 .158
(Difference) Standard Standard | 2-Tail | t Degrees of 2-Tail
Mean Deviation Error | Corr. Prob. | Value Freedom Prob.
| |
.3071 .169 .045 | .971 .000 | 6.82 13 .000
Paired samples t-test: ACTN0 BASE ACTINIC KERATOSIS SEVERITY
ACTN2 WK-1 ACTINIC KERATOSIS SEVERITY
Variable Number Standard Standard
of Cases Mean Deviation Error
ACTN0 14 3.5929 .664 .177
ACTN2 14 3.8000 .660 .176
(Difference) Standard Standard | 2-Tail | t Degrees of 2-Tail
Mean Deviation Error | Corr. Prob. | Value Freedom Prob.
| |
-.2071 .693 .185 | .451 .105 | -1.12 13 .284
Page 34 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Paired samples t-test: ACTN0 BASE ACTINIC KERATOSIS SEVERITY
ACTN4 WK-4 ACTINIC KERATOSIS SEVERITY
Variable Number Standard Standard
of Cases Mean Deviation Error
ACTN0 13 3.5308 .647 .180
ACTN4 13 3.3462 .425 .118
(Difference) Standard Standard | 2-Tail | t Degrees of 2-Tail
Mean Deviation Error | Corr. Prob. | Value Freedom Prob.
| |
.1846 .552 .153 | .536 .059 | 1.21 12 .251
Paired samples t-test: ACTN0 BASE ACTINIC KERATOSIS SEVERITY
ACTN8 WK-4 ACTINIC KERATOSIS SEVERITY
Variable Number Standard Standard
of Cases Mean Deviation Error
ACTN0 14 3.5929 .664 .177
ACTN8 14 2.9571 .520 .139
(Difference) Standard Standard | 2-Tail | t Degrees of 2-Tail
Mean Deviation Error | Corr. Prob. | Value Freedom Prob.
| |
.6357 .714 .191 | .291 .313 | 3.33 13 .005
Paired samples t-test: HEMO0 BASE SIASCOPE - HEMOGLOBIN
HEMO2 WK-1 SIASCOPE - HEMOGLOBIN
Variable Number Standard Standard
of Cases Mean Deviation Error
HEMO0 33 470.9861 45.003 7.834
HEMO2 33 569.7064 73.715 12.832
(Difference) Standard Standard | 2-Tail | t Degrees of 2-Tail
Mean Deviation Error | Corr. Prob. | Value Freedom Prob.
| |
-98.7203 83.157 14.476 | .082 .650 | -6.82 32 .000
Page 35 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Paired samples t-test: HEMO0 BASE SIASCOPE - HEMOGLOBIN
HEMO4 WK-4 SIASCOPE - HEMOGLOBIN
Variable Number Standard Standard
of Cases Mean Deviation Error
HEMO0 32 469.3497 44.715 7.905
HEMO4 32 169.2016 23.730 4.195
(Difference) Standard Standard | 2-Tail | t Degrees of 2-Tail
Mean Deviation Error | Corr. Prob. | Value Freedom Prob.
| |
300.1481 51.138 9.040 | -.025 .893 | 33.20 31 .000
Paired samples t-test: HEMO0 BASE SIASCOPE - HEMOGLOBIN
HEMO8 WK-8 SIASCOPE - HEMOGLOBIN
Variable Number Standard Standard
of Cases Mean Deviation Error
HEMO0 33 470.9861 45.003 7.834
HEMO8 33 166.1955 29.322 5.104
(Difference) Standard Standard | 2-Tail | t Degrees of 2-Tail
Mean Deviation Error | Corr. Prob. | Value Freedom Prob.
| |
304.7906 57.905 10.080 | -.177 .324 | 30.24 32 .000
Page 36 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
ITEXT1 IMPRV IMMED TEXTURE/SMOOTHNESS
Valid Cum
Value Label Value Frequency Percent Percent Percent
IMPROVED 1.00 32 97.0 97.0 97.0
SAME 2.00 1 3.0 3.0 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
ILINE1 IMPRV IMMED FINE LINES (CROWS FEET)
Valid Cum
Value Label Value Frequency Percent Percent Percent
IMPROVED 1.00 33 100.0 100.0 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
IRADI1 IMPRV IMMED RADIANCE
Valid Cum
Value Label Value Frequency Percent Percent Percent
IMPROVED 1.00 31 93.9 93.9 93.9
SAME 2.00 2 6.1 6.1 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
ILAXI1 IMPRV IMMED EYELID LAXITY
Valid Cum
Value Label Value Frequency Percent Percent Percent
IMPROVED 1.00 24 72.7 72.7 72.7
SAME 2.00 3 9.1 9.1 81.8
WORSE 3.00 6 18.2 18.2 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
Page 37 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
IELAS1 IMPRV IMMED ELASTICITY
Valid Cum
Value Label Value Frequency Percent Percent Percent
IMPROVED 1.00 31 93.9 93.9 93.9
SAME 2.00 1 3.0 3.0 97.0
WORSE 3.00 1 3.0 3.0 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
IOVER1 IMPRV IMMED OVERALL APPEARANCE
Valid Cum
Value Label Value Frequency Percent Percent Percent
IMPROVED 1.00 28 84.8 84.8 84.8
SAME 2.00 1 3.0 3.0 87.9
WORSE 3.00 4 12.1 12.1 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
ICAPL1 IMPRV IMMED CAPILLARY VISIBILITY
Valid Cum
Value Label Value Frequency Percent Percent Percent
IMPROVED 1.00 15 45.5 78.9 78.9
WORSE 3.00 4 12.1 21.1 100.0
. 14 42.4 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 19 Missing Cases 14
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
IACTN1 IMPRV IMMED ACTINIC KERATOSIS SEVERITY
Valid Cum
Value Label Value Frequency Percent Percent Percent
IMPROVED 1.00 13 39.4 92.9 92.9
SAME 2.00 1 3.0 7.1 100.0
. 19 57.6 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 14 Missing Cases 19
Page 38 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
ITEXT2 IMPRV WK-1 TEXTURE/SMOOTHNESS
Valid Cum
Value Label Value Frequency Percent Percent Percent
IMPROVED 1.00 14 42.4 42.4 42.4
SAME 2.00 1 3.0 3.0 45.5
WORSE 3.00 18 54.5 54.5 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
ILINE2 IMPRV WK-1 FINE LINES (CROWS FEET)
Valid Cum
Value Label Value Frequency Percent Percent Percent
IMPROVED 1.00 6 18.2 18.2 18.2
SAME 2.00 2 6.1 6.1 24.2
WORSE 3.00 25 75.8 75.8 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
IRADI2 IMPRV WK-1 RADIANCE
Valid Cum
Value Label Value Frequency Percent Percent Percent
IMPROVED 1.00 19 57.6 57.6 57.6
SAME 2.00 1 3.0 3.0 60.6
WORSE 3.00 13 39.4 39.4 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
ILAXI2 IMPRV WK-1 EYELID LAXITY
Valid Cum
Value Label Value Frequency Percent Percent Percent
IMPROVED 1.00 17 51.5 51.5 51.5
WORSE 3.00 16 48.5 48.5 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
Page 39 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
IELAS2 IMPRV WK-1 ELASTICITY
Valid Cum
Value Label Value Frequency Percent Percent Percent
IMPROVED 1.00 13 39.4 39.4 39.4
SAME 2.00 4 12.1 12.1 51.5
WORSE 3.00 16 48.5 48.5 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
IOVER2 IMPRV WK-1 OVERALL APPEARANCE
Valid Cum
Value Label Value Frequency Percent Percent Percent
IMPROVED 1.00 23 69.7 69.7 69.7
SAME 2.00 1 3.0 3.0 72.7
WORSE 3.00 9 27.3 27.3 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
ICAPL2 IMPRV WK-1 CAPILLARY VISIBILITY
Valid Cum
Value Label Value Frequency Percent Percent Percent
IMPROVED 1.00 8 24.2 42.1 42.1
SAME 2.00 3 9.1 15.8 57.9
WORSE 3.00 8 24.2 42.1 100.0
. 14 42.4 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 19 Missing Cases 14
Page 40 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
IACTN2 IMPRV WK-1 ACTINIC KERATOSIS SEVERITY
Valid Cum
Value Label Value Frequency Percent Percent Percent
IMPROVED 1.00 5 15.2 35.7 35.7
SAME 2.00 1 3.0 7.1 42.9
WORSE 3.00 8 24.2 57.1 100.0
. 19 57.6 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 14 Missing Cases 19
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
IHEMO2 IMPRV WK-1 SIASCOPE - HEMOGLOBIN
Valid Cum
Value Label Value Frequency Percent Percent Percent
IMPROVED 1.00 1 3.0 3.0 3.0
WORSE 3.00 32 97.0 97.0 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
ITEXT4 IMPRV WK-4 TEXTURE/SMOOTHNESS
Valid Cum
Value Label Value Frequency Percent Percent Percent
IMPROVED 1.00 19 57.6 59.4 59.4
WORSE 3.00 13 39.4 40.6 100.0
. 1 3.0 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 32 Missing Cases 1
Page 41 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
ILINE4 IMPRV WK-4 FINE LINES (CROWS FEET)
Valid Cum
Value Label Value Frequency Percent Percent Percent
IMPROVED 1.00 20 60.6 62.5 62.5
SAME 2.00 2 6.1 6.3 68.8
WORSE 3.00 10 30.3 31.3 100.0
. 1 3.0 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 32 Missing Cases 1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
IRADI4 IMPRV WK-4 RADIANCE
Valid Cum
Value Label Value Frequency Percent Percent Percent
IMPROVED 1.00 27 81.8 84.4 84.4
SAME 2.00 1 3.0 3.1 87.5
WORSE 3.00 4 12.1 12.5 100.0
. 1 3.0 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 32 Missing Cases 1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
ILAXI4 IMPRV WK-4 EYELID LAXITY
Valid Cum
Value Label Value Frequency Percent Percent Percent
IMPROVED 1.00 19 57.6 59.4 59.4
SAME 2.00 3 9.1 9.4 68.8
WORSE 3.00 10 30.3 31.3 100.0
. 1 3.0 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 32 Missing Cases 1
Page 42 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
IELAS4 IMPRV WK-4 ELASTICITY
Valid Cum
Value Label Value Frequency Percent Percent Percent
IMPROVED 1.00 10 30.3 31.3 31.3
SAME 2.00 4 12.1 12.5 43.8
WORSE 3.00 18 54.5 56.3 100.0
. 1 3.0 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 32 Missing Cases 1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
IOVER4 IMPRV WK-4 OVERALL APPEARANCE
Valid Cum
Value Label Value Frequency Percent Percent Percent
IMPROVED 1.00 27 81.8 84.4 84.4
SAME 2.00 1 3.0 3.1 87.5
WORSE 3.00 4 12.1 12.5 100.0
. 1 3.0 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 32 Missing Cases 1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
ICAPL4 IMPRV WK-4 CAPILLARY VISIBILITY
Valid Cum
Value Label Value Frequency Percent Percent Percent
IMPROVED 1.00 16 48.5 88.9 88.9
SAME 2.00 1 3.0 5.6 94.4
WORSE 3.00 1 3.0 5.6 100.0
. 15 45.5 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 18 Missing Cases 15
Page 43 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
IACTN4 IMPRV WK-4 ACTINIC KERATOSIS SEVERITY
Valid Cum
Value Label Value Frequency Percent Percent Percent
IMPROVED 1.00 7 21.2 53.8 53.8
WORSE 3.00 6 18.2 46.2 100.0
. 20 60.6 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 13 Missing Cases 20
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
IHEMO4 IMPRV WK-4 SIASCOPE - HEMOGLOBIN
Valid Cum
Value Label Value Frequency Percent Percent Percent
WORSE 3.00 32 97.0 100.0 100.0
. 1 3.0 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 32 Missing Cases 1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
ITEXT8 IMPRV WK-8 TEXTURE/SMOOTHNESS
Valid Cum
Value Label Value Frequency Percent Percent Percent
IMPROVED 1.00 25 75.8 75.8 75.8
SAME 2.00 1 3.0 3.0 78.8
WORSE 3.00 7 21.2 21.2 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
ILINE8 IMPRV WK-8 FINE LINES (CROWS FEET)
Valid Cum
Value Label Value Frequency Percent Percent Percent
IMPROVED 1.00 29 87.9 87.9 87.9
SAME 2.00 1 3.0 3.0 90.9
WORSE 3.00 3 9.1 9.1 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
Page 44 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
IRADI8 IMPRV WK-8 RADIANCE
Valid Cum
Value Label Value Frequency Percent Percent Percent
IMPROVED 1.00 33 100.0 100.0 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
ILAXI8 IMPRV WK-8 EYELID LAXITY
Valid Cum
Value Label Value Frequency Percent Percent Percent
IMPROVED 1.00 27 81.8 81.8 81.8
SAME 2.00 2 6.1 6.1 87.9
WORSE 3.00 4 12.1 12.1 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
IELAS8 IMPRV WK-8 ELASTICITY
Valid Cum
Value Label Value Frequency Percent Percent Percent
IMPROVED 1.00 25 75.8 75.8 75.8
SAME 2.00 4 12.1 12.1 87.9
WORSE 3.00 4 12.1 12.1 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
IOVER8 IMPRV WK-8 OVERALL APPEARANCE
Valid Cum
Value Label Value Frequency Percent Percent Percent
IMPROVED 1.00 33 100.0 100.0 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
Page 45 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
ICAPL8 IMPRV WK-8 CAPILLARY VISIBILITY
Valid Cum
Value Label Value Frequency Percent Percent Percent
IMPROVED 1.00 17 51.5 89.5 89.5
SAME 2.00 1 3.0 5.3 94.7
WORSE 3.00 1 3.0 5.3 100.0
. 14 42.4 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 19 Missing Cases 14
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
IACTN8 IMPRV WK-8 ACTINIC KERATOSIS SEVERITY
Valid Cum
Value Label Value Frequency Percent Percent Percent
IMPROVED 1.00 13 39.4 92.9 92.9
WORSE 3.00 1 3.0 7.1 100.0
. 19 57.6 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 14 Missing Cases 19
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
IHEMO8 IMPRV WK-8 SIASCOPE - HEMOGLOBIN
Valid Cum
Value Label Value Frequency Percent Percent Percent
WORSE 3.00 33 100.0 100.0 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
Page 46 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Number of Valid Observations (Listwise) = 5.00
Variable TEXT0 BASE TEXTURE/SMOOTHNESS
Mean 4.052 S.E. Mean .086
Std Dev .491 Variance .241
Kurtosis -.439 S.E. Kurt .798
Skewness -.443 S.E. Skew .409
Range 2.000 Minimum 2.9
Maximum 4.9 Sum 133.700
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable LINE0 BASE FINE LINES (CROWS FEET)
Mean 4.200 S.E. Mean .150
Std Dev .860 Variance .740
Kurtosis .657 S.E. Kurt .798
Skewness .202 S.E. Skew .409
Range 3.900 Minimum 2.5
Maximum 6.4 Sum 138.600
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable RADI0 BASE RADIANCE
Mean 4.730 S.E. Mean .074
Std Dev .423 Variance .179
Kurtosis -.084 S.E. Kurt .798
Skewness -.480 S.E. Skew .409
Range 1.700 Minimum 3.7
Maximum 5.4 Sum 156.100
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable LAXI0 BASE EYELID LAXITY
Mean 3.861 S.E. Mean .158
Std Dev .905 Variance .819
Kurtosis -1.230 S.E. Kurt .798
Skewness -.190 S.E. Skew .409
Range 3.100 Minimum 2.3
Maximum 5.4 Sum 127.400
Valid Observations - 33 Missing Observations - 0
Page 47 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Number of Valid Observations (Listwise) = 5.00
Variable ELAS0 BASE ELASTICITY
Mean 3.906 S.E. Mean .063
Std Dev .362 Variance .131
Kurtosis .172 S.E. Kurt .798
Skewness .754 S.E. Skew .409
Range 1.600 Minimum 3.2
Maximum 4.8 Sum 128.900
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable OVER0 BASE OVERALL APPEARANCE
Mean 4.809 S.E. Mean .067
Std Dev .386 Variance .149
Kurtosis 2.146 S.E. Kurt .798
Skewness -1.306 S.E. Skew .409
Range 1.800 Minimum 3.7
Maximum 5.5 Sum 158.700
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable CAPL0 BASE CAPILLARY VISIBILITY
Mean 4.389 S.E. Mean .156
Std Dev .681 Variance .463
Kurtosis -.691 S.E. Kurt 1.014
Skewness .347 S.E. Skew .524
Range 2.500 Minimum 3.3
Maximum 5.8 Sum 83.400
Valid Observations - 19 Missing Observations - 14
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable ACTN0 BASE ACTINIC KERATOSIS SEVERITY
Mean 3.593 S.E. Mean .177
Std Dev .664 Variance .441
Kurtosis -1.334 S.E. Kurt 1.154
Skewness -.145 S.E. Skew .597
Range 1.900 Minimum 2.6
Maximum 4.5 Sum 50.300
Valid Observations - 14 Missing Observations - 19
Page 48 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Number of Valid Observations (Listwise) = 5.00
Variable HEMO0 BASE SIASCOPE - HEMOGLOBIN
Mean 470.986 S.E. Mean 7.834
Std Dev 45.003 Variance 2025.294
Kurtosis .834 S.E. Kurt .798
Skewness -.876 S.E. Skew .409
Range 193.480 Minimum 343.40
Maximum 536.88 Sum 15542.540
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable TEXT1 IMMED TEXTURE/SMOOTHNESS
Mean 3.079 S.E. Mean .096
Std Dev .550 Variance .303
Kurtosis .137 S.E. Kurt .798
Skewness .865 S.E. Skew .409
Range 2.200 Minimum 2.2
Maximum 4.4 Sum 101.600
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable LINE1 IMMED FINE LINES (CROWS FEET)
Mean 3.715 S.E. Mean .135
Std Dev .776 Variance .603
Kurtosis .584 S.E. Kurt .798
Skewness .334 S.E. Skew .409
Range 3.500 Minimum 2.3
Maximum 5.8 Sum 122.600
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable RADI1 IMMED RADIANCE
Mean 3.200 S.E. Mean .104
Std Dev .598 Variance .358
Kurtosis -.703 S.E. Kurt .798
Skewness .436 S.E. Skew .409
Range 2.100 Minimum 2.2
Maximum 4.3 Sum 105.600
Valid Observations - 33 Missing Observations - 0
Page 49 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Number of Valid Observations (Listwise) = 5.00
Variable LAXI1 IMMED EYELID LAXITY
Mean 3.670 S.E. Mean .149
Std Dev .853 Variance .728
Kurtosis -.926 S.E. Kurt .798
Skewness -.213 S.E. Skew .409
Range 3.200 Minimum 2.1
Maximum 5.3 Sum 121.100
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable ELAS1 IMMED ELASTICITY
Mean 3.467 S.E. Mean .063
Std Dev .359 Variance .129
Kurtosis .126 S.E. Kurt .798
Skewness -.459 S.E. Skew .409
Range 1.500 Minimum 2.7
Maximum 4.2 Sum 114.400
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable OVER1 IMMED OVERALL APPEARANCE
Mean 4.258 S.E. Mean .100
Std Dev .575 Variance .331
Kurtosis .373 S.E. Kurt .798
Skewness -.788 S.E. Skew .409
Range 2.200 Minimum 2.9
Maximum 5.1 Sum 140.500
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable CAPL1 IMMED CAPILLARY VISIBILITY
Mean 4.147 S.E. Mean .163
Std Dev .711 Variance .505
Kurtosis -1.259 S.E. Kurt 1.014
Skewness .357 S.E. Skew .524
Range 2.300 Minimum 3.1
Maximum 5.4 Sum 78.800
Valid Observations - 19 Missing Observations - 14
Page 50 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Number of Valid Observations (Listwise) = 5.00
Variable ACTN1 IMMED ACTINIC KERATOSIS SEVERITY
Mean 3.286 S.E. Mean .158
Std Dev .589 Variance .347
Kurtosis -.903 S.E. Kurt 1.154
Skewness -.187 S.E. Skew .597
Range 1.900 Minimum 2.2
Maximum 4.1 Sum 46.000
Valid Observations - 14 Missing Observations - 19
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable TEXT2 WK-1 TEXTURE/SMOOTHNESS
Mean 4.273 S.E. Mean .078
Std Dev .446 Variance .199
Kurtosis .192 S.E. Kurt .798
Skewness -.098 S.E. Skew .409
Range 1.900 Minimum 3.3
Maximum 5.2 Sum 141.000
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable LINE2 WK-1 FINE LINES (CROWS FEET)
Mean 4.670 S.E. Mean .171
Std Dev .982 Variance .963
Kurtosis -.150 S.E. Kurt .798
Skewness -.715 S.E. Skew .409
Range 3.400 Minimum 2.5
Maximum 5.9 Sum 154.100
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable RADI2 WK-1 RADIANCE
Mean 4.664 S.E. Mean .101
Std Dev .578 Variance .334
Kurtosis -.329 S.E. Kurt .798
Skewness -.162 S.E. Skew .409
Range 2.200 Minimum 3.5
Maximum 5.7 Sum 153.900
Valid Observations - 33 Missing Observations - 0
Page 51 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Number of Valid Observations (Listwise) = 5.00
Variable LAXI2 WK-1 EYELID LAXITY
Mean 3.782 S.E. Mean .139
Std Dev .797 Variance .635
Kurtosis -.338 S.E. Kurt .798
Skewness .292 S.E. Skew .409
Range 3.200 Minimum 2.4
Maximum 5.6 Sum 124.800
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable ELAS2 WK-1 ELASTICITY
Mean 3.894 S.E. Mean .065
Std Dev .376 Variance .141
Kurtosis 2.319 S.E. Kurt .798
Skewness .746 S.E. Skew .409
Range 1.900 Minimum 3.1
Maximum 5.0 Sum 128.500
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable OVER2 WK-1 OVERALL APPEARANCE
Mean 4.615 S.E. Mean .062
Std Dev .355 Variance .126
Kurtosis -.047 S.E. Kurt .798
Skewness -.343 S.E. Skew .409
Range 1.400 Minimum 3.8
Maximum 5.2 Sum 152.300
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable CAPL2 WK-1 CAPILLARY VISIBILITY
Mean 4.379 S.E. Mean .150
Std Dev .654 Variance .427
Kurtosis -1.473 S.E. Kurt 1.014
Skewness .297 S.E. Skew .524
Range 1.900 Minimum 3.5
Maximum 5.4 Sum 83.200
Valid Observations - 19 Missing Observations - 14
Page 52 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Number of Valid Observations (Listwise) = 5.00
Variable ACTN2 WK-1 ACTINIC KERATOSIS SEVERITY
Mean 3.800 S.E. Mean .176
Std Dev .660 Variance .435
Kurtosis -.684 S.E. Kurt 1.154
Skewness .375 S.E. Skew .597
Range 2.200 Minimum 2.9
Maximum 5.1 Sum 53.200
Valid Observations - 14 Missing Observations - 19
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable HEMO2 WK-1 SIASCOPE - HEMOGLOBIN
Mean 569.706 S.E. Mean 12.832
Std Dev 73.715 Variance 5433.973
Kurtosis 9.405 S.E. Kurt .798
Skewness -2.256 S.E. Skew .409
Range 447.300 Minimum 258.50
Maximum 705.80 Sum 18800.310
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable TEXT4 WK-4 TEXTURE/SMOOTHNESS
Mean 4.122 S.E. Mean .049
Std Dev .276 Variance .076
Kurtosis .369 S.E. Kurt .809
Skewness -.430 S.E. Skew .414
Range 1.300 Minimum 3.4
Maximum 4.7 Sum 131.900
Valid Observations - 32 Missing Observations - 1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable LINE4 WK-4 FINE LINES (CROWS FEET)
Mean 4.003 S.E. Mean .146
Std Dev .824 Variance .678
Kurtosis -.531 S.E. Kurt .809
Skewness -.280 S.E. Skew .414
Range 3.100 Minimum 2.3
Maximum 5.4 Sum 128.100
Valid Observations - 32 Missing Observations - 1
Page 53 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Number of Valid Observations (Listwise) = 5.00
Variable RADI4 WK-4 RADIANCE
Mean 4.209 S.E. Mean .068
Std Dev .386 Variance .149
Kurtosis -.249 S.E. Kurt .809
Skewness .609 S.E. Skew .414
Range 1.500 Minimum 3.6
Maximum 5.1 Sum 134.700
Valid Observations - 32 Missing Observations - 1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable LAXI4 WK-4 EYELID LAXITY
Mean 3.500 S.E. Mean .104
Std Dev .590 Variance .348
Kurtosis -1.187 S.E. Kurt .809
Skewness -.140 S.E. Skew .414
Range 2.100 Minimum 2.4
Maximum 4.5 Sum 112.000
Valid Observations - 32 Missing Observations - 1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable ELAS4 WK-4 ELASTICITY
Mean 3.975 S.E. Mean .049
Std Dev .278 Variance .077
Kurtosis -.084 S.E. Kurt .809
Skewness .141 S.E. Skew .414
Range 1.100 Minimum 3.4
Maximum 4.5 Sum 127.200
Valid Observations - 32 Missing Observations - 1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable OVER4 WK-4 OVERALL APPEARANCE
Mean 4.338 S.E. Mean .062
Std Dev .350 Variance .122
Kurtosis 3.241 S.E. Kurt .809
Skewness -.658 S.E. Skew .414
Range 2.000 Minimum 3.2
Maximum 5.2 Sum 138.800
Valid Observations - 32 Missing Observations - 1
Page 54 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Number of Valid Observations (Listwise) = 5.00
Variable CAPL4 WK-4 CAPILLARY VISIBILITY
Mean 3.928 S.E. Mean .135
Std Dev .573 Variance .328
Kurtosis -.825 S.E. Kurt 1.038
Skewness -.039 S.E. Skew .536
Range 1.900 Minimum 2.9
Maximum 4.8 Sum 70.700
Valid Observations - 18 Missing Observations - 15
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable ACTN4 WK-4 ACTINIC KERATOSIS SEVERITY
Mean 3.346 S.E. Mean .118
Std Dev .425 Variance .181
Kurtosis -.024 S.E. Kurt 1.191
Skewness .458 S.E. Skew .616
Range 1.500 Minimum 2.7
Maximum 4.2 Sum 43.500
Valid Observations - 13 Missing Observations - 20
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable HEMO4 WK-4 SIASCOPE - HEMOGLOBIN
Mean 169.202 S.E. Mean 4.195
Std Dev 23.730 Variance 563.122
Kurtosis -.751 S.E. Kurt .809
Skewness .353 S.E. Skew .414
Range 83.500 Minimum 129.20
Maximum 212.70 Sum 5414.450
Valid Observations - 32 Missing Observations - 1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable TEXT8 WK-8 TEXTURE/SMOOTHNESS
Mean 3.594 S.E. Mean .085
Std Dev .490 Variance .241
Kurtosis -1.058 S.E. Kurt .798
Skewness -.195 S.E. Skew .409
Range 1.800 Minimum 2.7
Maximum 4.5 Sum 118.600
Valid Observations - 33 Missing Observations - 0
Page 55 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Number of Valid Observations (Listwise) = 5.00
Variable LINE8 WK-8 FINE LINES (CROWS FEET)
Mean 3.482 S.E. Mean .136
Std Dev .783 Variance .613
Kurtosis .398 S.E. Kurt .798
Skewness -.966 S.E. Skew .409
Range 3.400 Minimum 1.3
Maximum 4.7 Sum 114.900
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable RADI8 WK-8 RADIANCE
Mean 3.203 S.E. Mean .127
Std Dev .727 Variance .528
Kurtosis -.321 S.E. Kurt .798
Skewness -.224 S.E. Skew .409
Range 3.000 Minimum 1.5
Maximum 4.5 Sum 105.700
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable LAXI8 WK-8 EYELID LAXITY
Mean 3.233 S.E. Mean .106
Std Dev .610 Variance .372
Kurtosis -.192 S.E. Kurt .798
Skewness .157 S.E. Skew .409
Range 2.700 Minimum 1.8
Maximum 4.5 Sum 106.700
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable ELAS8 WK-8 ELASTICITY
Mean 3.506 S.E. Mean .061
Std Dev .352 Variance .124
Kurtosis 1.350 S.E. Kurt .798
Skewness -.719 S.E. Skew .409
Range 1.700 Minimum 2.5
Maximum 4.2 Sum 115.700
Valid Observations - 33 Missing Observations - 0
Page 56 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Number of Valid Observations (Listwise) = 5.00
Variable OVER8 WK-8 OVERALL APPEARANCE
Mean 3.803 S.E. Mean .090
Std Dev .516 Variance .267
Kurtosis 1.190 S.E. Kurt .798
Skewness -1.144 S.E. Skew .409
Range 2.200 Minimum 2.3
Maximum 4.5 Sum 125.500
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable CAPL8 WK-8 CAPILLARY VISIBILITY
Mean 3.263 S.E. Mean .142
Std Dev .618 Variance .381
Kurtosis -.895 S.E. Kurt 1.014
Skewness -.154 S.E. Skew .524
Range 2.100 Minimum 2.1
Maximum 4.2 Sum 62.000
Valid Observations - 19 Missing Observations - 14
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable ACTN8 WK-4 ACTINIC KERATOSIS SEVERITY
Mean 2.957 S.E. Mean .139
Std Dev .520 Variance .270
Kurtosis -.959 S.E. Kurt 1.154
Skewness .638 S.E. Skew .597
Range 1.600 Minimum 2.3
Maximum 3.9 Sum 41.400
Valid Observations - 14 Missing Observations - 19
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable HEMO8 WK-8 SIASCOPE - HEMOGLOBIN
Mean 166.195 S.E. Mean 5.104
Std Dev 29.322 Variance 859.778
Kurtosis -.492 S.E. Kurt .798
Skewness .669 S.E. Skew .409
Range 102.200 Minimum 129.20
Maximum 231.40 Sum 5484.450
Valid Observations - 33 Missing Observations - 0
Page 57 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Number of Valid Observations (Listwise) = 5.00
Variable DTEXT1 DIFF IMMED TEXTURE/SMOOTHNESS
Mean -.973 S.E. Mean .092
Std Dev .526 Variance .276
Kurtosis -.661 S.E. Kurt .798
Skewness -.322 S.E. Skew .409
Range 2.100 Minimum -2.10
Maximum .00 Sum -32.100
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable DLINE1 DIFF IMMED FINE LINES (CROWS FEET)
Mean -.485 S.E. Mean .035
Std Dev .203 Variance .041
Kurtosis -.688 S.E. Kurt .798
Skewness .066 S.E. Skew .409
Range .700 Minimum -.80
Maximum -.10 Sum -16.000
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable DRADI1 DIFF IMMED RADIANCE
Mean -1.530 S.E. Mean .141
Std Dev .810 Variance .655
Kurtosis -.964 S.E. Kurt .798
Skewness .320 S.E. Skew .409
Range 2.700 Minimum -2.70
Maximum .00 Sum -50.500
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable DLAXI1 DIFF IMMED EYELID LAXITY
Mean -.191 S.E. Mean .050
Std Dev .285 Variance .081
Kurtosis -.228 S.E. Kurt .798
Skewness .306 S.E. Skew .409
Range 1.200 Minimum -.80
Maximum .40 Sum -6.300
Valid Observations - 33 Missing Observations - 0
Page 58 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Number of Valid Observations (Listwise) = 5.00
Variable DELAS1 DIFF IMMED ELASTICITY
Mean -.439 S.E. Mean .058
Std Dev .335 Variance .112
Kurtosis .183 S.E. Kurt .798
Skewness -.127 S.E. Skew .409
Range 1.500 Minimum -1.10
Maximum .40 Sum -14.500
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable DOVER1 DIFF IMMED OVERALL APPEARANCE
Mean -.552 S.E. Mean .078
Std Dev .451 Variance .203
Kurtosis 1.367 S.E. Kurt .798
Skewness -.836 S.E. Skew .409
Range 2.000 Minimum -1.90
Maximum .10 Sum -18.200
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable DCAPL1 DIFF IMMED CAPILLARY VISIBILITY
Mean -.242 S.E. Mean .059
Std Dev .257 Variance .066
Kurtosis 1.156 S.E. Kurt 1.014
Skewness -.707 S.E. Skew .524
Range 1.000 Minimum -.90
Maximum .10 Sum -4.600
Valid Observations - 19 Missing Observations - 14
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable DACTN1 DIFF IMMED ACTINIC KERATOSIS SEVERITY
Mean -.307 S.E. Mean .045
Std Dev .169 Variance .028
Kurtosis -.979 S.E. Kurt 1.154
Skewness .580 S.E. Skew .597
Range .500 Minimum -.50
Maximum .00 Sum -4.300
Valid Observations - 14 Missing Observations - 19
Page 59 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Number of Valid Observations (Listwise) = 5.00
Variable DTEXT2 DIFF WK-1 TEXTURE/SMOOTHNESS
Mean .221 S.E. Mean .118
Std Dev .676 Variance .457
Kurtosis -.219 S.E. Kurt .798
Skewness .408 S.E. Skew .409
Range 2.800 Minimum -1.10
Maximum 1.70 Sum 7.300
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable DLINE2 DIFF WK-1 FINE LINES (CROWS FEET)
Mean .470 S.E. Mean .140
Std Dev .803 Variance .644
Kurtosis .482 S.E. Kurt .798
Skewness -.119 S.E. Skew .409
Range 3.700 Minimum -1.40
Maximum 2.30 Sum 15.500
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable DRADI2 DIFF WK-1 RADIANCE
Mean -.067 S.E. Mean .082
Std Dev .469 Variance .220
Kurtosis .620 S.E. Kurt .798
Skewness .299 S.E. Skew .409
Range 2.200 Minimum -1.00
Maximum 1.20 Sum -2.200
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable DLAXI2 DIFF WK-1 EYELID LAXITY
Mean -.079 S.E. Mean .133
Std Dev .766 Variance .587
Kurtosis -.475 S.E. Kurt .798
Skewness -.002 S.E. Skew .409
Range 3.100 Minimum -1.60
Maximum 1.50 Sum -2.600
Valid Observations - 33 Missing Observations - 0
Page 60 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Number of Valid Observations (Listwise) = 5.00
Variable DELAS2 DIFF WK-1 ELASTICITY
Mean -.012 S.E. Mean .069
Std Dev .397 Variance .158
Kurtosis -.501 S.E. Kurt .798
Skewness -.458 S.E. Skew .409
Range 1.600 Minimum -.90
Maximum .70 Sum -.400
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable DOVER2 DIFF WK-1 OVERALL APPEARANCE
Mean -.194 S.E. Mean .068
Std Dev .390 Variance .152
Kurtosis .268 S.E. Kurt .798
Skewness .522 S.E. Skew .409
Range 1.800 Minimum -1.00
Maximum .80 Sum -6.400
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable DCAPL2 DIFF WK-1 CAPILLARY VISIBILITY
Mean -.011 S.E. Mean .088
Std Dev .386 Variance .149
Kurtosis -.770 S.E. Kurt 1.014
Skewness .135 S.E. Skew .524
Range 1.300 Minimum -.60
Maximum .70 Sum -.200
Valid Observations - 19 Missing Observations - 14
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable DACTN2 DIFF WK-1 ACTINIC KERATOSIS SEVERITY
Mean .207 S.E. Mean .185
Std Dev .693 Variance .481
Kurtosis 1.707 S.E. Kurt 1.154
Skewness .743 S.E. Skew .597
Range 2.700 Minimum -.80
Maximum 1.90 Sum 2.900
Valid Observations - 14 Missing Observations - 19
Page 61 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Number of Valid Observations (Listwise) = 5.00
Variable DHEMO2 DIFF WK-1 SIASCOPE - HEMOGLOBIN
Mean 98.720 S.E. Mean 14.476
Std Dev 83.157 Variance 6915.138
Kurtosis 11.435 S.E. Kurt .798
Skewness -2.614 S.E. Skew .409
Range 490.240 Minimum -267.91
Maximum 222.33 Sum 3257.770
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable DTEXT4 DIFF WK-4 TEXTURE/SMOOTHNESS
Mean .050 S.E. Mean .089
Std Dev .502 Variance .252
Kurtosis -.057 S.E. Kurt .809
Skewness .706 S.E. Skew .414
Range 2.000 Minimum -.70
Maximum 1.30 Sum 1.600
Valid Observations - 32 Missing Observations - 1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable DLINE4 DIFF WK-4 FINE LINES (CROWS FEET)
Mean -.216 S.E. Mean .116
Std Dev .655 Variance .429
Kurtosis .728 S.E. Kurt .809
Skewness -.330 S.E. Skew .414
Range 3.000 Minimum -1.80
Maximum 1.20 Sum -6.900
Valid Observations - 32 Missing Observations - 1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable DRADI4 DIFF WK-4 RADIANCE
Mean -.534 S.E. Mean .076
Std Dev .431 Variance .186
Kurtosis .008 S.E. Kurt .809
Skewness .706 S.E. Skew .414
Range 1.700 Minimum -1.30
Maximum .40 Sum -17.100
Valid Observations - 32 Missing Observations - 1
Page 62 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Number of Valid Observations (Listwise) = 5.00
Variable DLAXI4 DIFF WK-4 EYELID LAXITY
Mean -.316 S.E. Mean .114
Std Dev .645 Variance .416
Kurtosis -.483 S.E. Kurt .809
Skewness .357 S.E. Skew .414
Range 2.400 Minimum -1.30
Maximum 1.10 Sum -10.100
Valid Observations - 32 Missing Observations - 1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable DELAS4 DIFF WK-4 ELASTICITY
Mean .097 S.E. Mean .066
Std Dev .374 Variance .140
Kurtosis -.566 S.E. Kurt .809
Skewness .066 S.E. Skew .414
Range 1.400 Minimum -.50
Maximum .90 Sum 3.100
Valid Observations - 32 Missing Observations - 1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable DOVER4 DIFF WK-4 OVERALL APPEARANCE
Mean -.450 S.E. Mean .081
Std Dev .461 Variance .212
Kurtosis .507 S.E. Kurt .809
Skewness .102 S.E. Skew .414
Range 2.100 Minimum -1.60
Maximum .50 Sum -14.400
Valid Observations - 32 Missing Observations - 1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable DCAPL4 DIFF WK-4 CAPILLARY VISIBILITY
Mean -.522 S.E. Mean .110
Std Dev .467 Variance .218
Kurtosis 1.469 S.E. Kurt 1.038
Skewness -.469 S.E. Skew .536
Range 2.100 Minimum -1.70
Maximum .40 Sum -9.400
Valid Observations - 18 Missing Observations - 15
Page 63 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Number of Valid Observations (Listwise) = 5.00
Variable DACTN4 DIFF WK-4 ACTINIC KERATOSIS SEVERITY
Mean -.185 S.E. Mean .153
Std Dev .552 Variance .305
Kurtosis -1.125 S.E. Kurt 1.191
Skewness -.280 S.E. Skew .616
Range 1.800 Minimum -1.20
Maximum .60 Sum -2.400
Valid Observations - 13 Missing Observations - 20
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable DHEMO4 DIFF WK-4 SIASCOPE - HEMOGLOBIN
Mean -300.148 S.E. Mean 9.040
Std Dev 51.138 Variance 2615.132
Kurtosis 1.339 S.E. Kurt .809
Skewness .956 S.E. Skew .414
Range 224.170 Minimum -381.97
Maximum -157.80 Sum -9604.740
Valid Observations - 32 Missing Observations - 1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable DTEXT8 DIFF WK-8 TEXTURE/SMOOTHNESS
Mean -.458 S.E. Mean .111
Std Dev .639 Variance .408
Kurtosis -.047 S.E. Kurt .798
Skewness .347 S.E. Skew .409
Range 2.700 Minimum -1.60
Maximum 1.10 Sum -15.100
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable DLINE8 DIFF WK-8 FINE LINES (CROWS FEET)
Mean -.718 S.E. Mean .108
Std Dev .622 Variance .387
Kurtosis .550 S.E. Kurt .798
Skewness -.645 S.E. Skew .409
Range 2.800 Minimum -2.50
Maximum .30 Sum -23.700
Valid Observations - 33 Missing Observations - 0
Page 64 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Number of Valid Observations (Listwise) = 5.00
Variable DRADI8 DIFF WK-8 RADIANCE
Mean -1.527 S.E. Mean .133
Std Dev .765 Variance .585
Kurtosis -.990 S.E. Kurt .798
Skewness -.193 S.E. Skew .409
Range 2.800 Minimum -2.90
Maximum -.10 Sum -50.400
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable DLAXI8 DIFF WK-8 EYELID LAXITY
Mean -.627 S.E. Mean .112
Std Dev .643 Variance .413
Kurtosis -.394 S.E. Kurt .798
Skewness -.536 S.E. Skew .409
Range 2.500 Minimum -2.00
Maximum .50 Sum -20.700
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable DELAS8 DIFF WK-8 ELASTICITY
Mean -.400 S.E. Mean .070
Std Dev .405 Variance .164
Kurtosis -.680 S.E. Kurt .798
Skewness -.190 S.E. Skew .409
Range 1.500 Minimum -1.20
Maximum .30 Sum -13.200
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable DOVER8 DIFF WK-8 OVERALL APPEARANCE
Mean -1.006 S.E. Mean .075
Std Dev .430 Variance .185
Kurtosis -.179 S.E. Kurt .798
Skewness -.556 S.E. Skew .409
Range 1.700 Minimum -2.00
Maximum -.30 Sum -33.200
Valid Observations - 33 Missing Observations - 0
Page 65 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Number of Valid Observations (Listwise) = 5.00
Variable DCAPL8 DIFF WK-8 CAPILLARY VISIBILITY
Mean -1.126 S.E. Mean .128
Std Dev .558 Variance .311
Kurtosis .680 S.E. Kurt 1.014
Skewness .758 S.E. Skew .524
Range 2.000 Minimum -1.90
Maximum .10 Sum -21.400
Valid Observations - 19 Missing Observations - 14
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable DACTN8 DIFF WK-8 ACTINIC KERATOSIS SEVERITY
Mean -.636 S.E. Mean .191
Std Dev .714 Variance .510
Kurtosis 1.147 S.E. Kurt 1.154
Skewness .409 S.E. Skew .597
Range 2.900 Minimum -1.90
Maximum 1.00 Sum -8.900
Valid Observations - 14 Missing Observations - 19
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable DHEMO8 DIFF WK-8 SIASCOPE - HEMOGLOBIN
Mean -304.791 S.E. Mean 10.080
Std Dev 57.905 Variance 3352.965
Kurtosis -.231 S.E. Kurt .798
Skewness .526 S.E. Skew .409
Range 215.210 Minimum -393.15
Maximum -177.94 Sum -10058.090
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable PTEXT1 % CHG IMMED TEXTURE/SMOOTHNESS
Mean -23.662 S.E. Mean 2.024
Std Dev 11.629 Variance 135.243
Kurtosis -.695 S.E. Kurt .798
Skewness -.086 S.E. Skew .409
Range 43.902 Minimum -43.90
Maximum .00 Sum -780.851
Valid Observations - 33 Missing Observations - 0
Page 66 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Number of Valid Observations (Listwise) = 5.00
Variable PLINE1 % CHG IMMED FINE LINES (CROWS FEET)
Mean -11.471 S.E. Mean .778
Std Dev 4.470 Variance 19.980
Kurtosis .130 S.E. Kurt .798
Skewness -.351 S.E. Skew .409
Range 18.355 Minimum -21.21
Maximum -2.86 Sum -378.538
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable PRADI1 % CHG IMMED RADIANCE
Mean -31.521 S.E. Mean 2.723
Std Dev 15.641 Variance 244.641
Kurtosis -.787 S.E. Kurt .798
Skewness .469 S.E. Skew .409
Range 52.174 Minimum -52.17
Maximum .00 Sum -1040.196
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable PLAXI1 % CHG IMMED EYELID LAXITY
Mean -4.594 S.E. Mean 1.431
Std Dev 8.218 Variance 67.536
Kurtosis .423 S.E. Kurt .798
Skewness .727 S.E. Skew .409
Range 34.413 Minimum -17.02
Maximum 17.39 Sum -151.606
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable PELAS1 % CHG IMMED ELASTICITY
Mean -10.981 S.E. Mean 1.473
Std Dev 8.463 Variance 71.628
Kurtosis .876 S.E. Kurt .798
Skewness .065 S.E. Skew .409
Range 40.705 Minimum -28.21
Maximum 12.50 Sum -362.376
Valid Observations - 33 Missing Observations - 0
Page 67 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Number of Valid Observations (Listwise) = 5.00
Variable POVER1 % CHG IMMED OVERALL APPEARANCE
Mean -11.486 S.E. Mean 1.664
Std Dev 9.562 Variance 91.427
Kurtosis 1.318 S.E. Kurt .798
Skewness -.883 S.E. Skew .409
Range 41.856 Minimum -39.58
Maximum 2.27 Sum -379.048
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable PCAPL1 % CHG IMMED CAPILLARY VISIBILITY
Mean -5.565 S.E. Mean 1.353
Std Dev 5.897 Variance 34.776
Kurtosis 1.158 S.E. Kurt 1.014
Skewness -.699 S.E. Skew .524
Range 23.232 Minimum -20.45
Maximum 2.78 Sum -105.727
Valid Observations - 19 Missing Observations - 14
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable PACTN1 % CHG IMMED ACTINIC KERATOSIS SEVERITY
Mean -8.371 S.E. Mean 1.207
Std Dev 4.515 Variance 20.383
Kurtosis -.725 S.E. Kurt 1.154
Skewness .508 S.E. Skew .597
Range 15.385 Minimum -15.38
Maximum .00 Sum -117.200
Valid Observations - 14 Missing Observations - 19
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable PTEXT2 % CHG WK-1 TEXTURE/SMOOTHNESS
Mean 7.196 S.E. Mean 3.295
Std Dev 18.928 Variance 358.272
Kurtosis .497 S.E. Kurt .798
Skewness .905 S.E. Skew .409
Range 81.537 Minimum -22.92
Maximum 58.62 Sum 237.458
Valid Observations - 33 Missing Observations - 0
Page 68 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Number of Valid Observations (Listwise) = 5.00
Variable PLINE2 % CHG WK-1 FINE LINES (CROWS FEET)
Mean 12.965 S.E. Mean 3.952
Std Dev 22.705 Variance 515.508
Kurtosis 1.193 S.E. Kurt .798
Skewness .463 S.E. Skew .409
Range 108.974 Minimum -35.90
Maximum 73.08 Sum 427.837
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable PRADI2 % CHG WK-1 RADIANCE
Mean -1.282 S.E. Mean 1.754
Std Dev 10.079 Variance 101.576
Kurtosis 1.586 S.E. Kurt .798
Skewness .594 S.E. Skew .409
Range 51.491 Minimum -22.22
Maximum 29.27 Sum -42.306
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable PLAXI2 % CHG WK-1 EYELID LAXITY
Mean .901 S.E. Mean 3.857
Std Dev 22.157 Variance 490.931
Kurtosis .806 S.E. Kurt .798
Skewness .732 S.E. Skew .409
Range 96.543 Minimum -34.04
Maximum 62.50 Sum 29.744
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable PELAS2 % CHG WK-1 ELASTICITY
Mean .123 S.E. Mean 1.690
Std Dev 9.711 Variance 94.301
Kurtosis -.839 S.E. Kurt .798
Skewness -.333 S.E. Skew .409
Range 35.029 Minimum -18.75
Maximum 16.28 Sum 4.047
Valid Observations - 33 Missing Observations - 0
Page 69 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Number of Valid Observations (Listwise) = 5.00
Variable POVER2 % CHG WK-1 OVERALL APPEARANCE
Mean -3.637 S.E. Mean 1.488
Std Dev 8.547 Variance 73.046
Kurtosis 1.084 S.E. Kurt .798
Skewness .936 S.E. Skew .409
Range 39.234 Minimum -18.18
Maximum 21.05 Sum -120.030
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable PCAPL2 % CHG WK-1 CAPILLARY VISIBILITY
Mean .255 S.E. Mean 2.157
Std Dev 9.404 Variance 88.432
Kurtosis -.166 S.E. Kurt 1.014
Skewness .419 S.E. Skew .524
Range 34.545 Minimum -13.33
Maximum 21.21 Sum 4.851
Valid Observations - 19 Missing Observations - 14
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable PACTN2 % CHG WK-1 ACTINIC KERATOSIS SEVERITY
Mean 8.072 S.E. Mean 6.183
Std Dev 23.133 Variance 535.131
Kurtosis 4.442 S.E. Kurt 1.154
Skewness 1.622 S.E. Skew .597
Range 93.590 Minimum -20.51
Maximum 73.08 Sum 113.015
Valid Observations - 14 Missing Observations - 19
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable PHEMO2 % CHG WK-1 SIASCOPE - HEMOGLOBIN
Mean 21.993 S.E. Mean 3.183
Std Dev 18.286 Variance 334.384
Kurtosis 7.043 S.E. Kurt .798
Skewness -1.713 S.E. Skew .409
Range 100.825 Minimum -50.89
Maximum 49.93 Sum 725.784
Valid Observations - 33 Missing Observations - 0
Page 70 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Number of Valid Observations (Listwise) = 5.00
Variable PTEXT4 % CHG WK-4 TEXTURE/SMOOTHNESS
Mean 2.606 S.E. Mean 2.491
Std Dev 14.091 Variance 198.570
Kurtosis 1.375 S.E. Kurt .809
Skewness 1.201 S.E. Skew .414
Range 61.901 Minimum -17.07
Maximum 44.83 Sum 83.387
Valid Observations - 32 Missing Observations - 1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable PLINE4 % CHG WK-4 FINE LINES (CROWS FEET)
Mean -3.803 S.E. Mean 2.932
Std Dev 16.585 Variance 275.054
Kurtosis 2.157 S.E. Kurt .809
Skewness .476 S.E. Skew .414
Range 90.056 Minimum -43.90
Maximum 46.15 Sum -121.710
Valid Observations - 32 Missing Observations - 1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable PRADI4 % CHG WK-4 RADIANCE
Mean -10.840 S.E. Mean 1.591
Std Dev 9.001 Variance 81.015
Kurtosis .431 S.E. Kurt .809
Skewness .894 S.E. Skew .414
Range 36.301 Minimum -25.49
Maximum 10.81 Sum -346.867
Valid Observations - 32 Missing Observations - 1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable PLAXI4 % CHG WK-4 EYELID LAXITY
Mean -5.522 S.E. Mean 3.150
Std Dev 17.816 Variance 317.423
Kurtosis 1.009 S.E. Kurt .809
Skewness 1.023 S.E. Skew .414
Range 73.246 Minimum -31.58
Maximum 41.67 Sum -176.707
Valid Observations - 32 Missing Observations - 1
Page 71 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Number of Valid Observations (Listwise) = 5.00
Variable PELAS4 % CHG WK-4 ELASTICITY
Mean 3.048 S.E. Mean 1.719
Std Dev 9.722 Variance 94.524
Kurtosis -.514 S.E. Kurt .809
Skewness .210 S.E. Skew .414
Range 37.821 Minimum -12.82
Maximum 25.00 Sum 97.533
Valid Observations - 32 Missing Observations - 1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable POVER4 % CHG WK-4 OVERALL APPEARANCE
Mean -8.897 S.E. Mean 1.742
Std Dev 9.853 Variance 97.073
Kurtosis .968 S.E. Kurt .809
Skewness .304 S.E. Skew .414
Range 46.847 Minimum -33.33
Maximum 13.51 Sum -284.706
Valid Observations - 32 Missing Observations - 1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable PCAPL4 % CHG WK-4 CAPILLARY VISIBILITY
Mean -11.299 S.E. Mean 2.254
Std Dev 9.562 Variance 91.427
Kurtosis .114 S.E. Kurt 1.038
Skewness .301 S.E. Skew .536
Range 39.310 Minimum -29.31
Maximum 10.00 Sum -203.385
Valid Observations - 18 Missing Observations - 15
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable PACTN4 % CHG WK-4 ACTINIC KERATOSIS SEVERITY
Mean -3.291 S.E. Mean 4.219
Std Dev 15.212 Variance 231.402
Kurtosis -1.059 S.E. Kurt 1.191
Skewness .064 S.E. Skew .616
Range 51.648 Minimum -28.57
Maximum 23.08 Sum -42.779
Valid Observations - 13 Missing Observations - 20
Page 72 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Number of Valid Observations (Listwise) = 5.00
Variable PHEMO4 % CHG WK-4 SIASCOPE - HEMOGLOBIN
Mean -63.569 S.E. Mean 1.190
Std Dev 6.730 Variance 45.294
Kurtosis .784 S.E. Kurt .809
Skewness 1.084 S.E. Skew .414
Range 27.416 Minimum -73.37
Maximum -45.95 Sum -2034.212
Valid Observations - 32 Missing Observations - 1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable PTEXT8 % CHG WK-8 TEXTURE/SMOOTHNESS
Mean -10.139 S.E. Mean 2.780
Std Dev 15.972 Variance 255.098
Kurtosis .489 S.E. Kurt .798
Skewness .703 S.E. Skew .409
Range 69.562 Minimum -37.21
Maximum 32.35 Sum -334.589
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable PLINE8 % CHG WK-8 FINE LINES (CROWS FEET)
Mean -16.676 S.E. Mean 2.454
Std Dev 14.095 Variance 198.678
Kurtosis -.362 S.E. Kurt .798
Skewness -.392 S.E. Skew .409
Range 56.571 Minimum -48.00
Maximum 8.57 Sum -550.294
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable PRADI8 % CHG WK-8 RADIANCE
Mean -32.006 S.E. Mean 2.700
Std Dev 15.513 Variance 240.657
Kurtosis -.603 S.E. Kurt .798
Skewness -.249 S.E. Skew .409
Range 63.470 Minimum -65.91
Maximum -2.44 Sum -1056.195
Valid Observations - 33 Missing Observations - 0
Page 73 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Number of Valid Observations (Listwise) = 5.00
Variable PLAXI8 % CHG WK-8 EYELID LAXITY
Mean -14.088 S.E. Mean 2.538
Std Dev 14.578 Variance 212.509
Kurtosis -.227 S.E. Kurt .798
Skewness -.001 S.E. Skew .409
Range 61.784 Minimum -42.55
Maximum 19.23 Sum -464.912
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable PELAS8 % CHG WK-8 ELASTICITY
Mean -9.804 S.E. Mean 1.733
Std Dev 9.954 Variance 99.083
Kurtosis -.459 S.E. Kurt .798
Skewness -.091 S.E. Skew .409
Range 41.807 Minimum -32.43
Maximum 9.37 Sum -323.516
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable POVER8 % CHG WK-8 OVERALL APPEARANCE
Mean -20.910 S.E. Mean 1.586
Std Dev 9.110 Variance 83.000
Kurtosis .267 S.E. Kurt .798
Skewness -.822 S.E. Skew .409
Range 37.519 Minimum -43.90
Maximum -6.38 Sum -690.025
Valid Observations - 33 Missing Observations - 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable PCAPL8 % CHG WK-8 CAPILLARY VISIBILITY
Mean -25.193 S.E. Mean 2.871
Std Dev 12.514 Variance 156.597
Kurtosis .900 S.E. Kurt 1.014
Skewness .693 S.E. Skew .524
Range 50.132 Minimum -47.50
Maximum 2.63 Sum -478.669
Valid Observations - 19 Missing Observations - 14
Page 74 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
VISUALS/SIASCOPE
Number of Valid Observations (Listwise) = 5.00
Variable PACTN8 % CHG WK-4 ACTINIC KERATOSIS SEVERITY
Mean -15.499 S.E. Mean 5.313
Std Dev 19.878 Variance 395.130
Kurtosis 3.662 S.E. Kurt 1.154
Skewness 1.341 S.E. Skew .597
Range 83.700 Minimum -45.24
Maximum 38.46 Sum -216.990
Valid Observations - 14 Missing Observations - 19
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Variable PHEMO8 % CHG WK-8 SIASCOPE - HEMOGLOBIN
Mean -64.259 S.E. Mean 1.372
Std Dev 7.880 Variance 62.094
Kurtosis -.384 S.E. Kurt .798
Skewness .689 S.E. Skew .409
Range 28.052 Minimum -75.18
Maximum -47.13 Sum -2120.535
Valid Observations - 33 Missing Observations - 0
Page 75 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -IMMEDIATE-
AQ01 IMMED Q01 REDUCED CAPILLARY REDNESS
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 1 3.0 3.0 3.0
AGREE 2 5 15.2 15.2 18.2
NEUTRAL 3 24 72.7 72.7 90.9
DISAGREE 4 1 3.0 3.0 93.9
STRONG DISAGREE 5 2 6.1 6.1 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.939 Std Err .130 Median 3.000
Std Dev .747 Variance .559
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
AQ02 IMMED Q02 IMPROVED EYELID LAXITY
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 1 3.0 3.0 3.0
AGREE 2 8 24.2 24.2 27.3
NEUTRAL 3 21 63.6 63.6 90.9
DISAGREE 4 1 3.0 3.0 93.9
STRONG DISAGREE 5 2 6.1 6.1 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.848 Std Err .138 Median 3.000
Std Dev .795 Variance .633
Valid Cases 33 Missing Cases 0
Page 76 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -IMMEDIATE-
AQ03 IMMED Q03 IMPROVED FACIAL FIRMNESS
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 4 12.1 12.1 12.1
AGREE 2 13 39.4 39.4 51.5
NEUTRAL 3 14 42.4 42.4 93.9
DISAGREE 4 1 3.0 3.0 97.0
STRONG DISAGREE 5 1 3.0 3.0 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.455 Std Err .151 Median 2.000
Std Dev .869 Variance .756
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
AQ04 IMMED Q04 IMPROVED FACIAL ELASTICITY
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 4 12.1 12.1 12.1
AGREE 2 16 48.5 48.5 60.6
NEUTRAL 3 11 33.3 33.3 93.9
DISAGREE 4 1 3.0 3.0 97.0
STRONG DISAGREE 5 1 3.0 3.0 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.364 Std Err .150 Median 2.000
Std Dev .859 Variance .739
Valid Cases 33 Missing Cases 0
Page 77 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -IMMEDIATE-
AQ05 IMMED Q05 LIFTED FACIAL SKIN
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 3 9.1 9.1 9.1
AGREE 2 12 36.4 36.4 45.5
NEUTRAL 3 16 48.5 48.5 93.9
DISAGREE 4 1 3.0 3.0 97.0
STRONG DISAGREE 5 1 3.0 3.0 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.545 Std Err .145 Median 3.000
Std Dev .833 Variance .693
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
AQ06 IMMED Q06 TIGHTENED FACIAL SKIN
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 3 9.1 9.1 9.1
AGREE 2 19 57.6 57.6 66.7
NEUTRAL 3 9 27.3 27.3 93.9
DISAGREE 4 1 3.0 3.0 97.0
STRONG DISAGREE 5 1 3.0 3.0 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.333 Std Err .142 Median 2.000
Std Dev .816 Variance .667
Valid Cases 33 Missing Cases 0
Page 78 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -IMMEDIATE-
AQ07 IMMED Q07 IMPROVED LINES/WRINKLES
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 2 6.1 6.1 6.1
AGREE 2 4 12.1 12.1 18.2
NEUTRAL 3 24 72.7 72.7 90.9
DISAGREE 4 1 3.0 3.0 93.9
STRONG DISAGREE 5 2 6.1 6.1 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.909 Std Err .140 Median 3.000
Std Dev .805 Variance .648
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
AQ08 IMMED Q08 REDUCED LINES/WRINKLES
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 1 3.0 3.0 3.0
AGREE 2 4 12.1 12.1 15.2
NEUTRAL 3 25 75.8 75.8 90.9
DISAGREE 4 1 3.0 3.0 93.9
STRONG DISAGREE 5 2 6.1 6.1 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.970 Std Err .127 Median 3.000
Std Dev .728 Variance .530
Valid Cases 33 Missing Cases 0
Page 79 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -IMMEDIATE-
AQ09 IMMED Q09 FACIAL SKIN MORE RADIANT
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 1 3.0 3.0 3.0
AGREE 2 16 48.5 48.5 51.5
NEUTRAL 3 13 39.4 39.4 90.9
DISAGREE 4 2 6.1 6.1 97.0
STRONG DISAGREE 5 1 3.0 3.0 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.576 Std Err .138 Median 2.000
Std Dev .792 Variance .627
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
AQ10 IMMED Q10 FRESH YOUTH INFUSED GLOW
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 2 6.1 6.1 6.1
AGREE 2 12 36.4 36.4 42.4
NEUTRAL 3 16 48.5 48.5 90.9
DISAGREE 4 2 6.1 6.1 97.0
STRONG DISAGREE 5 1 3.0 3.0 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.636 Std Err .143 Median 3.000
Std Dev .822 Variance .676
Valid Cases 33 Missing Cases 0
Page 80 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -IMMEDIATE-
AQ11 IMMED Q11 ENHANCED OVERALL APPEARANCE
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 2 6.1 6.1 6.1
AGREE 2 13 39.4 39.4 45.5
NEUTRAL 3 15 45.5 45.5 90.9
DISAGREE 4 2 6.1 6.1 97.0
STRONG DISAGREE 5 1 3.0 3.0 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.606 Std Err .144 Median 3.000
Std Dev .827 Variance .684
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
AQ12 IMMED Q12 DID NOT EXPERIENCE IRRITATION
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 13 39.4 39.4 39.4
AGREE 2 11 33.3 33.3 72.7
NEUTRAL 3 7 21.2 21.2 93.9
DISAGREE 4 1 3.0 3.0 97.0
STRONG DISAGREE 5 1 3.0 3.0 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 1.970 Std Err .177 Median 2.000
Std Dev 1.015 Variance 1.030
Valid Cases 33 Missing Cases 0
Page 81 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -IMMEDIATE-
AQ13 IMMED Q13 RELIEF OF ACTINIC KERTOSIS
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 1 3.0 6.7 6.7
AGREE 2 3 9.1 20.0 26.7
NEUTRAL 3 9 27.3 60.0 86.7
DISAGREE 4 2 6.1 13.3 100.0
NOT APPLICABLE 6 18 54.5 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.800 Std Err .200 Median 3.000
Std Dev .775 Variance .600
Valid Cases 15 Missing Cases 18
Page 82 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -IMMEDIATE-
XAQ01 IMMED Q01 REDUCED CAPILLARY REDNESS
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 6 18.2 18.2 18.2
NEUT/NEGATIVE 2.00 27 81.8 81.8 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
XAQ02 IMMED Q02 IMPROVED EYELID LAXITY
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 9 27.3 27.3 27.3
NEUT/NEGATIVE 2.00 24 72.7 72.7 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
XAQ03 IMMED Q03 IMPROVED FACIAL FIRMNESS
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 17 51.5 51.5 51.5
NEUT/NEGATIVE 2.00 16 48.5 48.5 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
XAQ04 IMMED Q04 IMPROVED FACIAL ELASTICITY
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 20 60.6 60.6 60.6
NEUT/NEGATIVE 2.00 13 39.4 39.4 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
Page 83 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -IMMEDIATE-
XAQ05 IMMED Q05 LIFTED FACIAL SKIN
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 15 45.5 45.5 45.5
NEUT/NEGATIVE 2.00 18 54.5 54.5 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
XAQ06 IMMED Q06 TIGHTENED FACIAL SKIN
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 22 66.7 66.7 66.7
NEUT/NEGATIVE 2.00 11 33.3 33.3 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
XAQ07 IMMED Q07 IMPROVED LINES/WRINKLES
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 6 18.2 18.2 18.2
NEUT/NEGATIVE 2.00 27 81.8 81.8 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
XAQ08 IMMED Q08 REDUCED LINES/WRINKLES
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 5 15.2 15.2 15.2
NEUT/NEGATIVE 2.00 28 84.8 84.8 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
Page 84 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -IMMEDIATE-
XAQ09 IMMED Q09 FACIAL SKIN MORE RADIANT
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 17 51.5 51.5 51.5
NEUT/NEGATIVE 2.00 16 48.5 48.5 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
XAQ10 IMMED Q10 FRESH YOUTH INFUSED GLOW
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 14 42.4 42.4 42.4
NEUT/NEGATIVE 2.00 19 57.6 57.6 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
XAQ11 IMMED Q11 ENHANCED OVERALL APPEARANCE
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 15 45.5 45.5 45.5
NEUT/NEGATIVE 2.00 18 54.5 54.5 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
XAQ12 IMMED Q12 DID NOT EXPERIENCE IRRITATION
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 24 72.7 72.7 72.7
NEUT/NEGATIVE 2.00 9 27.3 27.3 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
Page 85 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -IMMEDIATE-
XAQ13 IMMED Q13 RELIEF OF ACTINIC KERTOSIS
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 4 12.1 26.7 26.7
NEUT/NEGATIVE 2.00 11 33.3 73.3 100.0
. 18 54.5 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 15 Missing Cases 18
Page 86 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -WEEK 1-
BQ01 WK-1 Q01 REDUCED CAPILLARY REDNESS
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 2 6.1 6.1 6.1
AGREE 2 11 33.3 33.3 39.4
NEUTRAL 3 16 48.5 48.5 87.9
DISAGREE 4 3 9.1 9.1 97.0
STRONG DISAGREE 5 1 3.0 3.0 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.697 Std Err .147 Median 3.000
Std Dev .847 Variance .718
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
BQ02 WK-1 Q02 IMPROVED EYELID LAXITY
Valid Cum
Value Label Value Frequency Percent Percent Percent
AGREE 2 12 36.4 36.4 36.4
NEUTRAL 3 18 54.5 54.5 90.9
DISAGREE 4 2 6.1 6.1 97.0
STRONG DISAGREE 5 1 3.0 3.0 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.758 Std Err .123 Median 3.000
Std Dev .708 Variance .502
Valid Cases 33 Missing Cases 0
Page 87 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -WEEK 1-
BQ03 WK-1 Q03 IMPROVED FACIAL FIRMNESS
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 3 9.1 9.1 9.1
AGREE 2 20 60.6 60.6 69.7
NEUTRAL 3 9 27.3 27.3 97.0
STRONG DISAGREE 5 1 3.0 3.0 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.273 Std Err .133 Median 2.000
Std Dev .761 Variance .580
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
BQ04 WK-1 Q04 IMPROVED FACIAL ELASTICITY
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 3 9.1 9.1 9.1
AGREE 2 17 51.5 51.5 60.6
NEUTRAL 3 11 33.3 33.3 93.9
DISAGREE 4 1 3.0 3.0 97.0
STRONG DISAGREE 5 1 3.0 3.0 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.394 Std Err .144 Median 2.000
Std Dev .827 Variance .684
Valid Cases 33 Missing Cases 0
Page 88 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -WEEK 1-
BQ05 WK-1 Q05 LIFTED FACIAL SKIN
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 3 9.1 9.1 9.1
AGREE 2 12 36.4 36.4 45.5
NEUTRAL 3 15 45.5 45.5 90.9
DISAGREE 4 2 6.1 6.1 97.0
STRONG DISAGREE 5 1 3.0 3.0 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.576 Std Err .151 Median 3.000
Std Dev .867 Variance .752
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
BQ06 WK-1 Q06 TIGHTENED FACIAL SKIN
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 3 9.1 9.1 9.1
AGREE 2 15 45.5 45.5 54.5
NEUTRAL 3 14 42.4 42.4 97.0
STRONG DISAGREE 5 1 3.0 3.0 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.424 Std Err .138 Median 2.000
Std Dev .792 Variance .627
Valid Cases 33 Missing Cases 0
Page 89 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -WEEK 1-
BQ07 WK-1 Q07 IMPROVED LINES/WRINKLES
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 1 3.0 3.0 3.0
AGREE 2 13 39.4 39.4 42.4
NEUTRAL 3 16 48.5 48.5 90.9
DISAGREE 4 2 6.1 6.1 97.0
STRONG DISAGREE 5 1 3.0 3.0 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.667 Std Err .135 Median 3.000
Std Dev .777 Variance .604
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
BQ08 WK-1 Q08 REDUCED LINES/WRINKLES
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 2 6.1 6.1 6.1
AGREE 2 12 36.4 36.4 42.4
NEUTRAL 3 16 48.5 48.5 90.9
DISAGREE 4 2 6.1 6.1 97.0
STRONG DISAGREE 5 1 3.0 3.0 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.636 Std Err .143 Median 3.000
Std Dev .822 Variance .676
Valid Cases 33 Missing Cases 0
Page 90 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -WEEK 1-
BQ09 WK-1 Q09 FACIAL SKIN MORE RADIANT
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 4 12.1 12.1 12.1
AGREE 2 17 51.5 51.5 63.6
NEUTRAL 3 10 30.3 30.3 93.9
DISAGREE 4 1 3.0 3.0 97.0
STRONG DISAGREE 5 1 3.0 3.0 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.333 Std Err .149 Median 2.000
Std Dev .854 Variance .729
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
BQ10 WK-1 Q10 FRESH YOUTH INFUSED GLOW
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 2 6.1 6.1 6.1
AGREE 2 18 54.5 54.5 60.6
NEUTRAL 3 10 30.3 30.3 90.9
DISAGREE 4 2 6.1 6.1 97.0
STRONG DISAGREE 5 1 3.0 3.0 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.455 Std Err .145 Median 2.000
Std Dev .833 Variance .693
Valid Cases 33 Missing Cases 0
Page 91 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -WEEK 1-
BQ11 WK-1 Q11 ENHANCED OVERALL APPEARANCE
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 4 12.1 12.1 12.1
AGREE 2 17 51.5 51.5 63.6
NEUTRAL 3 9 27.3 27.3 90.9
DISAGREE 4 2 6.1 6.1 97.0
STRONG DISAGREE 5 1 3.0 3.0 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.364 Std Err .156 Median 2.000
Std Dev .895 Variance .801
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
BQ12 WK-1 Q12 DID NOT EXPERIENCE IRRITATION
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 16 48.5 48.5 48.5
AGREE 2 15 45.5 45.5 93.9
NEUTRAL 3 2 6.1 6.1 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 1.576 Std Err .107 Median 2.000
Std Dev .614 Variance .377
Valid Cases 33 Missing Cases 0
Page 92 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -WEEK 1-
BQ13 WK-1 Q13 RELIEF OF ACTINIC KERTOSIS
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 3 9.1 21.4 21.4
AGREE 2 4 12.1 28.6 50.0
NEUTRAL 3 6 18.2 42.9 92.9
DISAGREE 4 1 3.0 7.1 100.0
NOT APPLICABLE 6 19 57.6 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.357 Std Err .248 Median 2.500
Std Dev .929 Variance .863
Valid Cases 14 Missing Cases 19
Page 93 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -WEEK 1-
XBQ01 WK-1 Q01 REDUCED CAPILLARY REDNESS
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 13 39.4 39.4 39.4
NEUT/NEGATIVE 2.00 20 60.6 60.6 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
XBQ02 WK-1 Q02 IMPROVED EYELID LAXITY
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 12 36.4 36.4 36.4
NEUT/NEGATIVE 2.00 21 63.6 63.6 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
XBQ03 WK-1 Q03 IMPROVED FACIAL FIRMNESS
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 23 69.7 69.7 69.7
NEUT/NEGATIVE 2.00 10 30.3 30.3 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
XBQ04 WK-1 Q04 IMPROVED FACIAL ELASTICITY
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 20 60.6 60.6 60.6
NEUT/NEGATIVE 2.00 13 39.4 39.4 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
Page 94 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -WEEK 1-
XBQ05 WK-1 Q05 LIFTED FACIAL SKIN
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 15 45.5 45.5 45.5
NEUT/NEGATIVE 2.00 18 54.5 54.5 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
XBQ06 WK-1 Q06 TIGHTENED FACIAL SKIN
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 18 54.5 54.5 54.5
NEUT/NEGATIVE 2.00 15 45.5 45.5 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
XBQ07 WK-1 Q07 IMPROVED LINES/WRINKLES
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 14 42.4 42.4 42.4
NEUT/NEGATIVE 2.00 19 57.6 57.6 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
XBQ08 WK-1 Q08 REDUCED LINES/WRINKLES
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 14 42.4 42.4 42.4
NEUT/NEGATIVE 2.00 19 57.6 57.6 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
Page 95 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -WEEK 1-
XBQ09 WK-1 Q09 FACIAL SKIN MORE RADIANT
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 21 63.6 63.6 63.6
NEUT/NEGATIVE 2.00 12 36.4 36.4 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
XBQ10 WK-1 Q10 FRESH YOUTH INFUSED GLOW
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 20 60.6 60.6 60.6
NEUT/NEGATIVE 2.00 13 39.4 39.4 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
XBQ11 WK-1 Q11 ENHANCED OVERALL APPEARANCE
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 21 63.6 63.6 63.6
NEUT/NEGATIVE 2.00 12 36.4 36.4 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
XBQ12 WK-1 Q12 DID NOT EXPERIENCE IRRITATION
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 31 93.9 93.9 93.9
NEUT/NEGATIVE 2.00 2 6.1 6.1 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
Page 96 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -WEEK 1-
XBQ13 WK-1 Q13 RELIEF OF ACTINIC KERTOSIS
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 7 21.2 50.0 50.0
NEUT/NEGATIVE 2.00 7 21.2 50.0 100.0
. 19 57.6 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 14 Missing Cases 19
Page 97 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -WEEK 4-
CQ01 WK-4 Q01 REDUCED CAPILLARY REDNESS
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 5 15.2 15.6 15.6
AGREE 2 9 27.3 28.1 43.8
NEUTRAL 3 14 42.4 43.8 87.5
DISAGREE 4 4 12.1 12.5 100.0
. 1 3.0 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.531 Std Err .162 Median 3.000
Std Dev .915 Variance .838
Valid Cases 32 Missing Cases 1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
CQ02 WK-4 Q02 IMPROVED EYELID LAXITY
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 4 12.1 12.5 12.5
AGREE 2 9 27.3 28.1 40.6
NEUTRAL 3 16 48.5 50.0 90.6
DISAGREE 4 3 9.1 9.4 100.0
. 1 3.0 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.563 Std Err .148 Median 3.000
Std Dev .840 Variance .706
Valid Cases 32 Missing Cases 1
Page 98 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -WEEK 4-
CQ03 WK-4 Q03 IMPROVED FACIAL FIRMNESS
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 4 12.1 12.5 12.5
AGREE 2 18 54.5 56.3 68.8
NEUTRAL 3 7 21.2 21.9 90.6
DISAGREE 4 2 6.1 6.3 96.9
STRONG DISAGREE 5 1 3.0 3.1 100.0
. 1 3.0 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.313 Std Err .158 Median 2.000
Std Dev .896 Variance .802
Valid Cases 32 Missing Cases 1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
CQ04 WK-4 Q04 IMPROVED FACIAL ELASTICITY
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 5 15.2 15.6 15.6
AGREE 2 18 54.5 56.3 71.9
NEUTRAL 3 7 21.2 21.9 93.8
DISAGREE 4 2 6.1 6.3 100.0
. 1 3.0 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.188 Std Err .138 Median 2.000
Std Dev .780 Variance .609
Valid Cases 32 Missing Cases 1
Page 99 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -WEEK 4-
CQ05 WK-4 Q05 LIFTED FACIAL SKIN
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 4 12.1 12.5 12.5
AGREE 2 12 36.4 37.5 50.0
NEUTRAL 3 14 42.4 43.8 93.8
DISAGREE 4 2 6.1 6.3 100.0
. 1 3.0 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.438 Std Err .142 Median 2.500
Std Dev .801 Variance .641
Valid Cases 32 Missing Cases 1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
CQ06 WK-4 Q06 TIGHTENED FACIAL SKIN
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 5 15.2 15.6 15.6
AGREE 2 17 51.5 53.1 68.8
NEUTRAL 3 8 24.2 25.0 93.8
DISAGREE 4 2 6.1 6.3 100.0
. 1 3.0 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.219 Std Err .140 Median 2.000
Std Dev .792 Variance .628
Valid Cases 32 Missing Cases 1
Page 100 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -WEEK 4-
CQ07 WK-4 Q07 IMPROVED LINES/WRINKLES
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 5 15.2 15.6 15.6
AGREE 2 7 21.2 21.9 37.5
NEUTRAL 3 17 51.5 53.1 90.6
DISAGREE 4 3 9.1 9.4 100.0
. 1 3.0 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.563 Std Err .155 Median 3.000
Std Dev .878 Variance .770
Valid Cases 32 Missing Cases 1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
CQ08 WK-4 Q08 REDUCED LINES/WRINKLES
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 4 12.1 12.5 12.5
AGREE 2 11 33.3 34.4 46.9
NEUTRAL 3 14 42.4 43.8 90.6
DISAGREE 4 3 9.1 9.4 100.0
. 1 3.0 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.500 Std Err .149 Median 3.000
Std Dev .842 Variance .710
Valid Cases 32 Missing Cases 1
Page 101 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -WEEK 4-
CQ09 WK-4 Q09 FACIAL SKIN MORE RADIANT
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 6 18.2 18.8 18.8
AGREE 2 17 51.5 53.1 71.9
NEUTRAL 3 7 21.2 21.9 93.8
DISAGREE 4 2 6.1 6.3 100.0
. 1 3.0 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.156 Std Err .143 Median 2.000
Std Dev .808 Variance .652
Valid Cases 32 Missing Cases 1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
CQ10 WK-4 Q10 FRESH YOUTH INFUSED GLOW
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 5 15.2 15.6 15.6
AGREE 2 15 45.5 46.9 62.5
NEUTRAL 3 11 33.3 34.4 96.9
DISAGREE 4 1 3.0 3.1 100.0
. 1 3.0 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.250 Std Err .135 Median 2.000
Std Dev .762 Variance .581
Valid Cases 32 Missing Cases 1
Page 102 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -WEEK 4-
CQ11 WK-4 Q11 ENHANCED OVERALL APPEARANCE
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 6 18.2 18.8 18.8
AGREE 2 19 57.6 59.4 78.1
NEUTRAL 3 6 18.2 18.8 96.9
DISAGREE 4 1 3.0 3.1 100.0
. 1 3.0 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.063 Std Err .127 Median 2.000
Std Dev .716 Variance .512
Valid Cases 32 Missing Cases 1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
CQ12 WK-4 Q12 DID NOT EXPERIENCE IRRITATION
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 13 39.4 40.6 40.6
AGREE 2 15 45.5 46.9 87.5
NEUTRAL 3 3 9.1 9.4 96.9
DISAGREE 4 1 3.0 3.1 100.0
. 1 3.0 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Mean 1.750 Std Err .135 Median 2.000
Std Dev .762 Variance .581
Valid Cases 32 Missing Cases 1
Page 103 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -WEEK 4-
CQ13 WK-4 Q13 RELIEF OF ACTINIC KERTOSIS
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 1 3.0 8.3 8.3
AGREE 2 4 12.1 33.3 41.7
NEUTRAL 3 6 18.2 50.0 91.7
DISAGREE 4 1 3.0 8.3 100.0
. 2 6.1 MISSING
NOT APPLICABLE 6 19 57.6 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.583 Std Err .229 Median 3.000
Std Dev .793 Variance .629
Valid Cases 12 Missing Cases 21
Page 104 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -WEEK 4-
XCQ01 WK-4 Q01 REDUCED CAPILLARY REDNESS
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 14 42.4 43.8 43.8
NEUT/NEGATIVE 2.00 18 54.5 56.3 100.0
. 1 3.0 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 32 Missing Cases 1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
XCQ02 WK-4 Q02 IMPROVED EYELID LAXITY
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 13 39.4 40.6 40.6
NEUT/NEGATIVE 2.00 19 57.6 59.4 100.0
. 1 3.0 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 32 Missing Cases 1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
XCQ03 WK-4 Q03 IMPROVED FACIAL FIRMNESS
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 22 66.7 68.8 68.8
NEUT/NEGATIVE 2.00 10 30.3 31.3 100.0
. 1 3.0 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 32 Missing Cases 1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
XCQ04 WK-4 Q04 IMPROVED FACIAL ELASTICITY
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 23 69.7 71.9 71.9
NEUT/NEGATIVE 2.00 9 27.3 28.1 100.0
. 1 3.0 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Page 105 of 117
Valid Cases 32 Missing Cases 1
Page 106 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -WEEK 4-
XCQ05 WK-4 Q05 LIFTED FACIAL SKIN
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 16 48.5 50.0 50.0
NEUT/NEGATIVE 2.00 16 48.5 50.0 100.0
. 1 3.0 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 32 Missing Cases 1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
XCQ06 WK-4 Q06 TIGHTENED FACIAL SKIN
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 22 66.7 68.8 68.8
NEUT/NEGATIVE 2.00 10 30.3 31.3 100.0
. 1 3.0 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 32 Missing Cases 1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
XCQ07 WK-4 Q07 IMPROVED LINES/WRINKLES
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 12 36.4 37.5 37.5
NEUT/NEGATIVE 2.00 20 60.6 62.5 100.0
. 1 3.0 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 32 Missing Cases 1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
XCQ08 WK-4 Q08 REDUCED LINES/WRINKLES
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 15 45.5 46.9 46.9
NEUT/NEGATIVE 2.00 17 51.5 53.1 100.0
. 1 3.0 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 32 Missing Cases 1
Page 107 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -WEEK 4-
XCQ09 WK-4 Q09 FACIAL SKIN MORE RADIANT
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 23 69.7 71.9 71.9
NEUT/NEGATIVE 2.00 9 27.3 28.1 100.0
. 1 3.0 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 32 Missing Cases 1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
XCQ10 WK-4 Q10 FRESH YOUTH INFUSED GLOW
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 20 60.6 62.5 62.5
NEUT/NEGATIVE 2.00 12 36.4 37.5 100.0
. 1 3.0 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 32 Missing Cases 1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
XCQ11 WK-4 Q11 ENHANCED OVERALL APPEARANCE
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 25 75.8 78.1 78.1
NEUT/NEGATIVE 2.00 7 21.2 21.9 100.0
. 1 3.0 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 32 Missing Cases 1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
XCQ12 WK-4 Q12 DID NOT EXPERIENCE IRRITATION
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 28 84.8 87.5 87.5
NEUT/NEGATIVE 2.00 4 12.1 12.5 100.0
. 1 3.0 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 32 Missing Cases 1
Page 108 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -WEEK 4-
XCQ13 WK-4 Q13 RELIEF OF ACTINIC KERTOSIS
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 5 15.2 41.7 41.7
NEUT/NEGATIVE 2.00 7 21.2 58.3 100.0
. 21 63.6 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 12 Missing Cases 21
Page 109 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -WEEK 8-
DQ01 WK-8 Q01 REDUCED CAPILLARY REDNESS
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 8 24.2 24.2 24.2
AGREE 2 11 33.3 33.3 57.6
NEUTRAL 3 12 36.4 36.4 93.9
DISAGREE 4 2 6.1 6.1 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.242 Std Err .157 Median 2.000
Std Dev .902 Variance .814
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
DQ02 WK-8 Q02 IMPROVED EYELID LAXITY
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 4 12.1 12.1 12.1
AGREE 2 15 45.5 45.5 57.6
NEUTRAL 3 11 33.3 33.3 90.9
DISAGREE 4 3 9.1 9.1 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.394 Std Err .144 Median 2.000
Std Dev .827 Variance .684
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
DQ03 WK-8 Q03 IMPROVED FACIAL FIRMNESS
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 9 27.3 27.3 27.3
AGREE 2 17 51.5 51.5 78.8
NEUTRAL 3 5 15.2 15.2 93.9
DISAGREE 4 2 6.1 6.1 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.000 Std Err .144 Median 2.000
Std Dev .829 Variance .688
Valid Cases 33 Missing Cases 0
Page 110 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -WEEK 8-
DQ04 WK-8 Q04 IMPROVED FACIAL ELASTICITY
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 5 15.2 15.2 15.2
AGREE 2 17 51.5 51.5 66.7
NEUTRAL 3 10 30.3 30.3 97.0
DISAGREE 4 1 3.0 3.0 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.212 Std Err .129 Median 2.000
Std Dev .740 Variance .547
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
DQ05 WK-8 Q05 LIFTED FACIAL SKIN
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 6 18.2 18.2 18.2
AGREE 2 12 36.4 36.4 54.5
NEUTRAL 3 14 42.4 42.4 97.0
DISAGREE 4 1 3.0 3.0 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.303 Std Err .141 Median 2.000
Std Dev .810 Variance .655
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
DQ06 WK-8 Q06 TIGHTENED FACIAL SKIN
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 8 24.2 24.2 24.2
AGREE 2 17 51.5 51.5 75.8
NEUTRAL 3 7 21.2 21.2 97.0
DISAGREE 4 1 3.0 3.0 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.030 Std Err .134 Median 2.000
Std Dev .770 Variance .593
Valid Cases 33 Missing Cases 0
Page 111 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -WEEK 8-
DQ07 WK-8 Q07 IMPROVED LINES/WRINKLES
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 6 18.2 18.2 18.2
AGREE 2 12 36.4 36.4 54.5
NEUTRAL 3 13 39.4 39.4 93.9
DISAGREE 4 2 6.1 6.1 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.333 Std Err .149 Median 2.000
Std Dev .854 Variance .729
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
DQ08 WK-8 Q08 REDUCED LINES/WRINKLES
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 6 18.2 18.2 18.2
AGREE 2 10 30.3 30.3 48.5
NEUTRAL 3 15 45.5 45.5 93.9
DISAGREE 4 2 6.1 6.1 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.394 Std Err .150 Median 3.000
Std Dev .864 Variance .746
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
DQ09 WK-8 Q09 FACIAL SKIN MORE RADIANT
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 9 27.3 27.3 27.3
AGREE 2 18 54.5 54.5 81.8
NEUTRAL 3 5 15.2 15.2 97.0
DISAGREE 4 1 3.0 3.0 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 1.939 Std Err .130 Median 2.000
Std Dev .747 Variance .559
Valid Cases 33 Missing Cases 0
Page 112 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -WEEK 8-
DQ10 WK-8 Q10 FRESH YOUTH INFUSED GLOW
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 7 21.2 21.2 21.2
AGREE 2 17 51.5 51.5 72.7
NEUTRAL 3 8 24.2 24.2 97.0
DISAGREE 4 1 3.0 3.0 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.091 Std Err .133 Median 2.000
Std Dev .765 Variance .585
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
DQ11 WK-8 Q11 ENHANCED OVERALL APPEARANCE
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 7 21.2 21.2 21.2
AGREE 2 18 54.5 54.5 75.8
NEUTRAL 3 7 21.2 21.2 97.0
DISAGREE 4 1 3.0 3.0 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.061 Std Err .130 Median 2.000
Std Dev .747 Variance .559
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
DQ12 WK-8 Q12 DID NOT EXPERIENCE IRRITATION
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 21 63.6 63.6 63.6
AGREE 2 9 27.3 27.3 90.9
NEUTRAL 3 3 9.1 9.1 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Mean 1.455 Std Err .116 Median 1.000
Std Dev .666 Variance .443
Valid Cases 33 Missing Cases 0
Page 113 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -WEEK 8-
DQ13 WK-8 Q13 RELIEF OF ACTINIC KERTOSIS
Valid Cum
Value Label Value Frequency Percent Percent Percent
STRONG AGREE 1 2 6.1 15.4 15.4
AGREE 2 4 12.1 30.8 46.2
NEUTRAL 3 6 18.2 46.2 92.3
DISAGREE 4 1 3.0 7.7 100.0
. 1 3.0 MISSING
NOT APPLICABLE 6 19 57.6 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Mean 2.462 Std Err .243 Median 3.000
Std Dev .877 Variance .769
Valid Cases 13 Missing Cases 20
Page 114 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -WEEK 8-
XDQ01 WK-8 Q01 REDUCED CAPILLARY REDNESS
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 19 57.6 57.6 57.6
NEUT/NEGATIVE 2.00 14 42.4 42.4 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
XDQ02 WK-8 Q02 IMPROVED EYELID LAXITY
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 19 57.6 57.6 57.6
NEUT/NEGATIVE 2.00 14 42.4 42.4 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
XDQ03 WK-8 Q03 IMPROVED FACIAL FIRMNESS
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 26 78.8 78.8 78.8
NEUT/NEGATIVE 2.00 7 21.2 21.2 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
XDQ04 WK-8 Q04 IMPROVED FACIAL ELASTICITY
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 22 66.7 66.7 66.7
NEUT/NEGATIVE 2.00 11 33.3 33.3 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
Page 115 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -WEEK 8-
XDQ05 WK-8 Q05 LIFTED FACIAL SKIN
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 18 54.5 54.5 54.5
NEUT/NEGATIVE 2.00 15 45.5 45.5 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
XDQ06 WK-8 Q06 TIGHTENED FACIAL SKIN
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 25 75.8 75.8 75.8
NEUT/NEGATIVE 2.00 8 24.2 24.2 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
XDQ07 WK-8 Q07 IMPROVED LINES/WRINKLES
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 18 54.5 54.5 54.5
NEUT/NEGATIVE 2.00 15 45.5 45.5 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
XDQ08 WK-8 Q08 REDUCED LINES/WRINKLES
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 16 48.5 48.5 48.5
NEUT/NEGATIVE 2.00 17 51.5 51.5 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
Page 116 of 117
IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -WEEK 8-
XDQ09 WK-8 Q09 FACIAL SKIN MORE RADIANT
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 27 81.8 81.8 81.8
NEUT/NEGATIVE 2.00 6 18.2 18.2 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
XDQ10 WK-8 Q10 FRESH YOUTH INFUSED GLOW
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 24 72.7 72.7 72.7
NEUT/NEGATIVE 2.00 9 27.3 27.3 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
XDQ11 WK-8 Q11 ENHANCED OVERALL APPEARANCE
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 25 75.8 75.8 75.8
NEUT/NEGATIVE 2.00 8 24.2 24.2 100.0
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 33 Missing Cases 0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
XDQ12 WK-8 Q12 DID NOT EXPERIENCE IRRITATION
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 28 84.8 87.5 87.5
NEUT/NEGATIVE 2.00 4 12.1 12.5 100.0
. 1 3.0 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 32 Missing Cases 1
Page 117 of 117
Page 100 IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3
QUESTIONNAIRE -WEEK 8-
XDQ13 WK-8 Q13 RELIEF OF ACTINIC KERTOSIS
Valid Cum
Value Label Value Frequency Percent Percent Percent
POSITIVE 1-2 1.00 6 18.2 46.2 46.2
NEUT/NEGATIVE 2.00 7 21.2 53.8 100.0
. 20 60.6 MISSING
------- ------- -------
TOTAL 33 100.0 100.0
Valid Cases 13 Missing Cases 20