skin appearance benefits from a 3-product salycylic acid anti acne regimen

7/28/2019 Skin Appearance Benefits From a 3-Product Salycylic Acid Anti Acne Regimen

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SKIN APPEARANCE BENEFITS FROM A3-PRODUCT SALICYLIC ACID ANTI-ACNE

REGIMEN

J . R. Kaczvinsky1, C. E. Mack1, L. L. Griffin1, J . Li1, R. A. Rose-Mansfield1,S. C. Weitz1, M. J . Marmor1, P. E. Grimes, MD2 and M. I. Perez, MD3

1The Procter & Gamble Company, Cincinnati, Ohio USA2UCLA Medical Center, Los Angeles, CA USA3Columbia University, New York, NY USA

Poster FC02-07


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Background

Mild to moderate acne vulgaris can persist in somewomen well past adolescence

The periodic appearance of inflamed lesions can be asignificant source of psychological and emotional distress

Many acne treatment products are harsh and notcompatible with other skin needs of post-adolescentwomen, such as those related to aged appearance.

A multi-product regimen containing salicylic acid was

designed that addresses both the acne treatment andskin appearance needs of these women


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Study Design Skin Benefit EndpointsObjective:

1. Compare the extent of beauty-related skin benefits for treatment with a 3-product

salicylic acid (SA) acne regimen versus a positive control regimen (2.5% benzoylperoxide; BP) and a placebo

Design:

Randomized, double-blind, placebo-controlled parallel group study

2 wks pre-conditioning, 12 wks treatment

~330 healthy post-adolescent females (aged 18-45)Mild to moderate acne (grades 2-3)Conducted at three separate (US) study sites

Measures:

Baseline and after 4, 8, and 12 weeks treatment

Skin texture by image analysis and subject self-assessmentEnlarged pores by image analysis and subject self-assessmentSkin barrier function (TEWL)

Skin hydration (capacitance)


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StudyTimeline

Assess

Assess

Assess

Assess

Pre-ConditioningCleanse with mild liquid cleanser

AM, PM: Placebo Moistur izer w/3% glycerin/SPF15

Wk -2

Wk 0

Wk +4

Wk +8

Wk +12

~110 subjects

SA Regimen

AM

SA Cleanser

(1.8% salicylic acid)SA Treatment(1.5% salicylic acid)

AA Moisturizer(5% niacinamide)

Sunscreen(3%gly/SPF15)

PM

SA Cleanser

SA Treatment

AA Moisturizer

BP Regimen

AM

Cleanser

(non-acne)BP Treatment

(2.5% benzoyl peroxide)

Sunscreen(3% gly/SPF15)

PM

Cleanser

BP Treatment

3% gly Moisturizer

Placebo

AM

Cleanser

(non-acne)Sunscreen(3%gly/SPF15)

PM

Olay FFW

3%gly Moisturizer

~110 subjects ~110 subjects


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Results Inflammatory Lesion Counts

Both BP and the SA regimens significantly reduced the number ofinflammatory lesions relative to the placebo treatment at all time points

Efficacy from the two test regimens was not significantly different

Mean 12-wk reductions were ~53% for the SA regimen and ~57% for BP

Data was logtransformedfor analysis

Reported datais backtransformed

There wassubstantialimprovementin the placebogroup


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Texture and Pore Analysis

REAL 3.0 system


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Results Skin Texture/Image Analysis

The SA regimen significantly improved facial skin texture comparedto the other two treatment regimens

BPs impact was negative but not significant compared to placebo

Texture

benefit notdriven byacne lesionresolution


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Results Skin Texture Self-Assessments

Subjects using the SA regimen noticed an improvement in theirskin texture throughout the study

This may be driven in part by clearance of their acne lesions

Subjects gradedtheir skin texture

on a 0-10 ptcontinuous scale

Absolute gradeswere given ateach time point

Lower numbermeans lessuneven (moreeven) texture

Subjects could

calibrate to theirlast grade


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Results Pore Area Image Analysis

Pore reduction

benefit notdriven by acnelesionresolution

The SA regimen significantly reduced the detectable pore area compared tothe other two treatment regimens

BP treatment increased pore area but not significantly compared to placebo


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Results Pore Size/Visibility Self Assessment

Subjects graded theirpore size/visibility ona 0-10 pt continuousscale; poor toexcellent

Significant benefits after 8 wks with the SA regimen and after 12 wks for BP

Results not completely driven by improvements in acne lesions


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Results Barrier Function (TEWL)

The SA regimen was similar to placebo with respect to barrier integrity

Possible balancing effect of niacinamide (known to provide barrierintegrity improvement) and salicylic acid

BP regimen treatment significantly compromised barrier

TEWL wasmeasured on thecheek with mostacne at baseline

Triplicate readingswere averaged

Vapometer


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Results Skin Hydration (Corneometer)

Hydration wasmeasured via

Corneometeronthe cheek mostbroken out atbaseline

Triplicate readingswere averaged

SA regimen treatment provided a significant hydration benefit early oncompared to placebo and BP; the comparative benefit and change vs.baseline was reduced over time

BP treatment had a negative effect, which improved over time


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Conclusions

The SA regimen used in this study significantly reduced inflammatoryacne lesions starting at 4 weeks treatment, compared to placebo

The acne benefits from the SA regimen were comparable to thoseachieved with twice daily use of 2.5% benzoyl peroxide.

The SA regimen improved skin texture as well as or better than both

2.5% benzoyl peroxide and placebo after 4 weeks treatment.

Four or more weeks treatment with the SA regimen significantlyreduced the area of enlarged pores and made them less visible

The SA regimen was more hydrating and less damaging to the skin

than 2.5% benzoyl peroxide and also provided additional skinbenefits.

The SA regimen provided both anti-acne efficacy and additionalbenefits for attributes related to skin aging. The latter benefits werenot achieved with a 2.5% BP regimen.


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This work was funded by P&G Beauty & Grooming

skin appearance benefits from a 3-product salycylic acid anti acne regimen

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