blu-001 blue peel radiance™ - obagi medical products...suzanne bruce, md 2 blu-001 blue peel...
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CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI DECEMBER 2012
BLU-001 Blue Peel RADIANCE™
FINAL ANALYSIS
December 2012 JoAnne Watson, D.P.M., Associate Director, Clinical Affairs
Barbara Coffey, Project Coordinator
BLU-001 Blue Peel RADIANCE™
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI DECEMBER 2012
A Single-Center Five-Week Open Label Study to Evaluate the
Efficacy of a Series of Three Peel Procedures using Obagi
Blue Peel RADIANCE ™ in the Improvement of the
Appearance of Facial Skin
INVESTIGATOR:
Suzanne Bruce, MD
2 2
BLU-001 Blue Peel RADIANCE™
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI DECEMBER 2012
Subjects (male and female) at one site in a 5 week study to
evaluate the efficacy and improvement in the appearance of the
facial skin after using the Obagi® Blue Peel RADIANCE™ peel in
a series of 3 peel procedures in subjects with mild to moderate
facial photodamage, fine lines and fine wrinkling, and /or mild
superficial acne scarring. Study subjects had a series of 3 Obagi®
Blue Peel RADIANCE™ peel procedures, approximately 2 weeks
apart.
3 3
STUDY DESIGN
BLU-001 Blue Peel RADIANCE™
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OMPI DECEMBER 2012
• Female or male subject, 21-45 years old, inclusive
• Have clinical diagnosis of mild to moderate facial photodamage,
fine lines and fine wrinkling, and/or mild superficial acne scarring
• Baseline Investigator Assessment Facial Overall Integrated
Photodamage Score 2-Mild or 3-Moderate
• Baseline Investigator Assessment Facial Overall Pigmentation
Intensity Scale 1-Minimal or 2-Mild
• Glogau Photodamage Classification Type I or Type II
• Fitzpatrick Skin Type II through light VI
4 4
MAIN INCLUSION CRITERIA
BLU-001 Blue Peel RADIANCE™
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI DECEMBER 2012
Home Use Study Products
AM PM
Nu-Derm® Gentle Cleanser
Nu-Derm® Sun Shield SPF 50
Nu-Derm® Gentle Cleanser
Subjects were provided with CLENZIderm™ Therapeutic Moisturizer and
instructed to use as needed for post-peel dryness, itching or redness.
STUDY TREATMENT REGIMEN
Obagi® Blue RADIANCE™ peel procedure done at Baseline Visit;
Day 14 Visit; Day 28 Visit (One layer Obagi® Blue RADIANCE™
per peel procedure.)
BLU-001 Blue Peel RADIANCE™
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OMPI DECEMBER 2012 6
DEMOGRAPHICS
N 15
Gender Female (%) 86.7 (N=13)
Gender Male (%) 13.3 (N=2)
Age (Mean) 36
White/Caucasian (%) 86.7 (N=13)
Black/African American (%) 6.7 (N=1)
Asian (%) 6.7 (N=1)
Fitzpatrick Skin Type II (%) 46.7 (N=7)
Fitzpatrick Skin Type III(%) 26.7 (N=4)
Fitzpatrick Skin Type IV (%) 20.0 (N=3)
Fitzpatrick Skin Type VI (%) 6.7 (N=1)
BLU-001 Blue Peel RADIANCE™
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OMPI DECEMBER 2012 7
DIAGNOSIS FOR PEEL
N 15
Photodamage (%) 53.3 (N=8)
Photodamage/ Acne Scarring (%)
13.3 (N=2)
Hyperpigmentation (%) 13.3 (N=2)
Acne Scarring/ Hyperpigmentation (%)
6.7 (N=1)
Tactile Roughness/ Dyspigmentation (%)
6.7 (N=1)
Sun Damage (%) 6.7 (N=1)
BLU-001 Blue Peel RADIANCE™
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI DECEMBER 2012
Investigator Assessments
BLU-001 Blue Peel RADIANCE™
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OMPI DECEMBER 2012 9 9
Investigator Assessment of Photodamage
Score Overall Facial Photodamage
0 None
1 Minimal
2 Mild
3 Moderate
4 Severe
BLU-001 Blue Peel RADIANCE™
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OMPI DECEMBER 2012 10 10
Investigator Assessment of
Pigmentation Intensity
Severity Score Overall Facial Pigmentation Intensity
None 0 No noticeable hyperpigmentation
Minimal 1 Localized deposits of pigment
Mild 2 Mild, diffuse deposits of pigment
Moderate 3 Moderate, diffuse deposits of pigment
Marked 4 Marked, dense deposits of pigment
Severe 5 Severe-dense deposits of pigment
BLU-001 Blue Peel RADIANCE™
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OMPI DECEMBER 2012 11
STATISTICAL ANALYSIS GRAPHS
INVESTIGATOR ASSESSMENTS
BASELINE THROUGH WEEK 5 VISIT
11
BLU-001 Blue Peel RADIANCE™
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OMPI DECEMBER 2012
7
13
7
27
6060
73
60
27
40
20
7
0
20
40
60
80
Screening Day 14 Day 28 Day 35
0 - None
1 - Minimal
2 - Mild
3 - Moderate
12 12
INVESTIGATOR ASSESSMENTS
FACIAL OVERALL INTEGRATED ASSESSMENT OF PHOTODAMAGE
BY VISIT
Percentage of Subjects
BLU-001 Blue Peel RADIANCE™
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI DECEMBER 2012
2.42.1
1.7
1.1
0.0
1.0
2.0
3.0
Screening Day 14 Day 28 Day 35
13
Mean Scores
Scale None (0) Minimal (1) Mild (2) Moderate (3)
INVESTIGATOR ASSESSMENTS
FACIAL OVERALL INTEGRATED ASSESSMENT OF PHOTODAMAGE
BY VISIT
BLU-001 Blue Peel RADIANCE™
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI DECEMBER 2012
27%
53%
80%
0%
20%
40%
60%
80%
100%
Day 14 Day 28 Day 35
Sub
ject
s (%
)
≥ 1 grade improvement
INVESTIGATOR ASSESSMENTS
FACIAL OVERALL INTEGRATED ASSESSMENT OF PHOTODAMAGE
(IMPROVEMENT FROM BASELINE)
14
BLU-001 Blue Peel RADIANCE™
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI DECEMBER 2012
7 7
20
27
33
47
60
53 53
40
2020
7 7
0
20
40
60
80
Screening Day 14 Day 28 Day 35
0 - None
1 - Minimal
2 - Mild
3 - Moderate
15 15
INVESTIGATOR ASSESSMENTS
PHOTODAMAGE CHARACTERISTICS – APPEARANCE OF
FINE LINES AND WRINKLES BY VISIT
Percentage of Subjects
BLU-001 Blue Peel RADIANCE™
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI DECEMBER 2012
1.91.6 1.5
1.0
0.0
1.0
2.0
3.0
Screening Day 14 Day 28 Day 35
16
Mean Scores
Scale None (0) Minimal (1) Mild (2) Moderate (3) Severe (4)
INVESTIGATOR ASSESSMENTS
PHOTODAMAGE CHARACTERISTICS – APPEARANCE OF
FINE LINES AND WRINKLES BY VISIT
BLU-001 Blue Peel RADIANCE™
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI DECEMBER 2012
33%40%
80%
0%
20%
40%
60%
80%
100%
Day 14 Day 28 Day 35
Sub
ject
s (%
)
≥ 1 grade improvement
INVESTIGATOR ASSESSMENTS
PHOTODAMAGE CHARACTERISTICS – APPEARANCE OF
FINE LINES AND WRINKLES BY VISIT
(IMPROVEMENT FROM BASELINE)
17
BLU-001 Blue Peel RADIANCE™
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI DECEMBER 2012
27
60
80
4047
33
20
47
20
713
7
0
20
40
60
80
100
Screening Day 14 Day 28 Day 35
0 - None
1 - Minimal
2 - Mild
3 - Moderate
18 18
INVESTIGATOR ASSESSMENTS
PHOTODAMAGE CHARACTERISTICS – TACTILE ROUGHNESS
BY VISIT
Percentage of Subjects
BLU-001 Blue Peel RADIANCE™
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI DECEMBER 2012
1.7
1.1
0.5
0.2
0.0
1.0
2.0
Screening Day 14 Day 28 Day 35
19
Mean Scores
Scale None (0) Minimal (1) Mild (2) Moderate (3) Severe (4)
INVESTIGATOR ASSESSMENTS
PHOTODAMAGE CHARACTERISTICS – TACTILE ROUGHNESS
BY VISIT
BLU-001 Blue Peel RADIANCE™
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI DECEMBER 2012
67%
0%
20%
40%
60%
80%
100%
Day 14 Day 28 Day 35
Sub
ject
s (%
)
≥ 1 grade improvement
20
INVESTIGATOR ASSESSMENTS
PHOTODAMAGE CHARACTERISTICS – TACTILE ROUGHNESS
BY VISIT
(IMPROVEMENT FROM BASELINE)
100% 100%
BLU-001 Blue Peel RADIANCE™
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OMPI DECEMBER 2012
7
2013
93
8087
100
0
20
40
60
80
100
Baseline Day 14 Day 28 Day 35
0 - No
1 - Yes
21 21
INVESTIGATOR ASSESSMENTS
APPEARANCE OF FACIAL SKIN FIRMNESS /INCREASE FIRMNESS
CHANGE FROM BASELINE (ASSESSED FROM BASELINE PRE-PEEL PHOTO)
Percentage of Subjects
BLU-001 Blue Peel RADIANCE™
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI DECEMBER 2012
7
2727
40
53
60
73
60
40
13
0
20
40
60
80
Screening Day 14 Day 28 Day 35
0 - None
1 - Minimal
2 - Mild
22 22
INVESTIGATOR ASSESSMENTS
OVERALL FACIAL PIGMENTATION INTENSITY
BY VISIT
Percentage of Subjects
BLU-001 Blue Peel RADIANCE™
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI DECEMBER 2012
1.71.6
1.3
0.9
0.0
1.0
2.0
Screening Day 14 Day 28 Day 35
23
Mean Scores
Scale None (0) Minimal (1) Mild (2) Moderate (3) Severe (4)
INVESTIGATOR ASSESSMENTS
OVERALL FACIAL PIGMENTATION INTENSITY
BY VISIT
BLU-001 Blue Peel RADIANCE™
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI DECEMBER 2012
13%
40%
67%
0%
20%
40%
60%
80%
Day 14 Day 28 Day 35
Sub
ject
s (%
)
≥ 1 grade improvement
24
INVESTIGATOR ASSESSMENTS
OVERALL FACIAL PIGMENTATION INTENSITY
BY VISIT
BLU-001 Blue Peel RADIANCE™
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI DECEMBER 2012
100 100 100 100
0
20
40
60
80
100
Baseline (Peel #1) Day 14 (Peel #2) Day 28 ( Peel #3) Day 35 (Study Exit)
0 - No
1 - Yes
25 25
INVESTIGATOR ASSESSMENTS
SKIN APPEARS TIGHTER, SMOOTHER AND BRIGHTER LOOKING
CHANGE FROM BASELINE (ASSESSED FROM BASELINE PRE-PEEL PHOTO)
Percentage of Subjects
BLU-001 Blue Peel RADIANCE™
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OMPI DECEMBER 2012 26
TREATMENT RELATED
ADVERSE EVENTS
TOTAL # SUBJECTS
ADVERSE EVENT DESCRIPTION
AE INTENSITY
COMMENTS
1 Acne Flare Mild Acne flare stopped 11/10/12.
1 Worsening of Acne, Face
Mild Worsening of acne still ongoing 12/6/12.
No subjects discontinued due to treatment-related adverse events.
BLU-001 Blue Peel RADIANCE™
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OMPI DECEMBER 2012 27
SUBJECT QUESTIONNAIRE RESPONSES
BASELINE, DAY 14, DAY 18 AND DAY 35 VISIT
BLU-001 Blue Peel RADIANCE™
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OMPI DECEMBER 2012 28
SUBJECT QUESTIONNAIRE RESPONSES CURRENT SATISFACTION WITH SKIN FEATURES
BASELINE
(compared to Baseline pre-peel photo)
Percent (%) of Subjects
DAY 35
(compared to Baseline pre-peel photo)
Percent (%) of Subjects
Extremely
unsatisfied Unsatisfied Neutral Satisfied
Very
satisfied
Extremely
satisfied
Extremely
unsatisfied Unsatisfied Neutral Satisfied
Very
satisfied
Extremely
satisfied
– Appearance of fine
lines and wrinkles 6.7 53.3 26.7 6.7 6.7 13.3 26.7 26.7 33.3
– Smoothness of skin 40 40 13.3 6.7 6.7 40 53.3
– Firmness of skin 60 20 20 20 46.7 26.7 6.7
– Moisture level of skin 40 40 20 33.3 46.7 20
– Consistent skin tone
and coloration 26.7 46.7 20 6.7 6.7 20 53.3 20
– Appearance of brown
spots 40 53.3 6.7 26.7 40 26.7 6.7
– Pore size 20 40 40 6.7 33.3 40 20
– Glow/brightness of
skin 53.3 40 6.7 6.7 66.7 13.3 13.3
– Overall appearance
of skin 6.7 66.7 20 6.7 6.7 26.7 40 26.7
BLU-001 Blue Peel RADIANCE™
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OMPI DECEMBER 2012 29
SUBJECT QUESTIONNAIRE RESPONSES SATISFACTION WITH PEEL PROCEDURE
DAY 14
(compared to Baseline pre-peel photo)
Percent (%) of Subjects
DAY 28
(compared to Baseline pre-peel photo)
Percent (%) of Subjects
Disagree
strongly
Disagree
Neutral
Agree
some
Agree
Agree
strongly
Disagree
strongly
Disagree
Neutral
Agree
some
Agree
Agree
strongly
I would continue to have this
facial peel procedure
performed.
6.7 46.7 46.7 6.7 6.7 33.3 53.3
I would recommend this facial
peel procedure to my friends. 13.3 13.3 33.3 40 20 13.3 40 26.7
The results of this facial peel
procedure were what I
expected.
6.7 20 33.3 26.7 13.3 13.3 6.7 20 46.7 13.3
The results of this facial peel
procedure were better than I
expected.
6.7 33.3 26.7 20 13.3 6.7 6.7 33.3 26.7 20 6.7
There was minimal downtime
after this facial peel procedure. 6.7 13.3 6.7 26.7 46.7 6.7 6.7 20 13.3 53.3
BLU-001 Blue Peel RADIANCE™
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OMPI DECEMBER 2012 30
SUBJECT QUESTIONNAIRE RESPONSES SATISFACTION WITH PEEL PROCEDURE
DAY 35
(compared to Baseline pre-peel photo)
Percent (%) of Subjects
Disagree
strongly
Disagree
Neutral
Agree
some
Agree
Agree
strongly
I would continue to have this
facial peel procedure
performed.
26.7 6.7 26.7 40
I would recommend this facial
peel procedure to my friends. 13.3 13.3 33.3 40
The results of this facial peel
procedure were what I
expected.
13.3 26.7 46.7 13.3
The results of this facial peel
procedure were better than I
expected.
13.3 26.7 40 20
There was minimal downtime
after this facial peel procedure. 6.7 13.3 26.7 53.3
BLU-001 Blue Peel RADIANCE™
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OMPI DECEMBER 2012 31
When did you first notice an improvement in
your skin’s appearance?
After the
1st Peel
After the
2nd Peel
After the
3rd Peel
I did not notice any
changes
40 46.7 6.7 6.7
Please rate your overall satisfaction
with the peel procedures you
received during this study.
Extremely
unsatisfied
Very
unsatisfied
Unsatisfied
Neutral
Satisfied
Very
satisfied
Extremely
satisfied
6.7 13.3 40 26.7 13.3
If you have received other facial aesthetic
treatments before this study, how would you
rate your results with this peel procedure
compared to previous facial treatments?
N/A
Much
worse
Worse
The same
Better
Much
better
60 13.3 20 6.7
SUBJECT QUESTIONNAIRE RESPONSES DAY 35
Percent (%) of Subjects
BLU-001 Blue Peel RADIANCE™
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI DECEMBER 2012
0
20
40
60
80
100
Subject ratings
of satisfied,
very satisfied,
or extremely
satisfied (%)
Appearance
of fine lines
and wrinkles
Firmness of
skin
Smoothness
of skin
60% 53% Very
Satisfied
Moisture
level of
skin
13% Good
7% Extremely Sat.
Satisfaction with Skin Features
at Day 35
32
93%
81%
67%
33% Very
Satisfied
27% Very
Satisfied 20% Very
Satisfied
27%
Satisfied
40%
Satisfied
47%
Satisfied 47%
Satisfied
BLU-001 Blue Peel RADIANCE™
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI DECEMBER 2012
0
20
40
60
80
100
Subject ratings
of satisfied,
very satisfied,
or extremely
satisfied (%)
Consistent
skin tone &
coloration
Pore
size Appearance
of brown
spots
73%
20% Very
Satisfied
Overall
appearance
of skin
13% Extremely
Satisfied
Satisfaction with Skin Features
at Day 35
33
20% Very
Satisfied
53%
Satisfied
Glow/
brightness
of skin
7% Very Sat.
27%
Satisfied
40%
Satisfied
67%
Satisfied 40%
Satisfied
13% Very
Satisfied
27% Very
Satisfied
34%
60%
93%
67%
BLU-001 Blue Peel RADIANCE™
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI DECEMBER 2012 34
SAMPLE SUBJECT PHOTOGRAPHS
34
SUBJECT 001 KLJ
OMP, INC. BLU001
SUZANNE BRUCE, MD
1 WEEK AFTER PEEL #3
(35 DAYS FROM BASELINE)
BASELINE PRE-PEEL
BASELINE PRE-PEEL
1 WEEK AFTER PEEL #3
(35 DAYS FROM BASELINE)
SUBJECT 001 KLJ
SUBJECT 005 JKK
OMP, INC. BLU001
SUZANNE BRUCE, MD
1 WEEK AFTER PEEL #3
(35 DAYS FROM BASELINE)
BASELINE PRE-PEEL
SUBJECT 005 JKK
OMP, INC. BLU001
SUZANNE BRUCE, MD
1 WEEK AFTER PEEL #3
(35 DAYS FROM BASELINE)
BASELINE PRE-PEEL
BASELINE PRE-PEEL
1 WEEK AFTER PEEL #3
(35 DAYS FROM BASELINE)
SUBJECT 005 JKK
SUBJECT 006 APH
OMP, INC. BLU001
SUZANNE BRUCE, MD
1 WEEK AFTER PEEL #3
(35 DAYS FROM BASELINE)
BASELINE PRE-PEEL
SUBJECT 006 APH
OMP, INC. BLU001
SUZANNE BRUCE, MD
1 WEEK AFTER PEEL #3
(35 DAYS FROM BASELINE)
BASELINE PRE-PEEL
1 WEEK AFTER PEEL #3
(35 DAYS FROM BASELINE)
BASELINE PRE-PEEL
SUBJECT 006 APH
SUBJECT 007 JEK
OMP, INC. BLU001
SUZANNE BRUCE, MD
1 WEEK AFTER PEEL #3
(35 DAYS FROM BASELINE)
BASELINE PRE-PEEL
SUBJECT 007 JEK
OMP, INC. BLU001
SUZANNE BRUCE, MD
BASELINE PRE-PEEL
1 WEEK AFTER PEEL #3
(35 DAYS FROM BASELINE)
BASELINE PRE-PEEL
1 WEEK AFTER PEEL #3
(35 DAYS FROM BASELINE)
SUBJECT 007 JEK
SUBJECT 009 YNC
OMP, INC. BLU001
SUZANNE BRUCE, MD
1 WEEK AFTER PEEL #3
(35 DAYS FROM BASELINE)
BASELINE PRE-PEEL
BASELINE PRE-PEEL
1 WEEK AFTER PEEL #3
(35 DAYS FROM BASELINE)
SUBJECT 009 YNC
SUBJECT 010 ALR
OMP, INC. BLU001
SUZANNE BRUCE, MD
2 WEEKS AFTER PEEL #2
BASELINE PRE-PEEL
SUBJECT 010 ALR
OMP, INC. BLU001
SUZANNE BRUCE, MD
2 WEEKS AFTER PEEL #2
BASELINE PRE-PEEL
BASELINE PRE-PEEL
SUBJECT 010 ALR
2 WEEKS AFTER PEEL #2
SUBJECT 012 JAE
OMP, INC. BLU001
SUZANNE BRUCE, MD
1 WEEK AFTER PEEL #3
(35 DAYS FROM BASELINE)
BASELINE PRE-PEEL
SUBJECT 012 JAE
OMP, INC. BLU001
SUZANNE BRUCE, MD
1 WEEK AFTER PEEL #3
(35 DAYS FROM BASELINE)
BASELINE PRE-PEEL
BASELINE PRE-PEEL
1 WEEK AFTER PEEL #3
(35 DAYS FROM BASELINE)
SUBJECT 012 JAE
1 WEEK AFTER PEEL #3
(35 DAYS FROM BASELINE)
BASELINE PRE-PEEL
SUBJECT 014 S-H
OMP, INC. BLU001
SUZANNE BRUCE, MD
1 WEEK AFTER PEEL #3
(35 DAYS FROM BASELINE)
BASELINE PRE-PEEL
SUBJECT 014 S-H
OMP, INC. BLU001
SUZANNE BRUCE, MD
BASELINE PRE-PEEL
1 WEEK AFTER PEEL #3
(35 DAYS FROM BASELINE)
SUBJECT 014 S-H
BLU-001 Blue Peel RADIANCE™
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OMPI DECEMBER 2012 57
CONCLUSIONS • 100% subjects had tighter, smoother, brighter looking skin after peel #1
• 100% subjects had minimal or no tactile roughness after series 3 peels
• 100% subjects had at least 1 grade improvement tactile roughness after peel #2
• 93% subjects had firmer appearing skin after peel #1
• 80% subjects had at least 1 grade improvement in appearance of fine
lines and wrinkles after series 3 peels
• 67% subjects had at least 1 grade improvement in pigmentation intensity after series 3 peels
• 80% subjects at least satisfied with series of 3 peels
• Most visible improvement seen in photo images after peel #3