SKIN APPEARANCE BENEFITS FROM A 3-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 USA 2UCLA Medical Center, Los Angeles, CA USA 3Columbia University, New York, NY USA

Poster FC02-07

Background
Mild to moderate acne vulgaris can persist in some women well past adolescence The periodic appearance of inflamed lesions can be a significant source of psychological and emotional distress Many acne treatment products are harsh and not compatible with other skin needs of post-adolescent women, such as those related to aged appearance. A multi-product regimen containing salicylic acid was designed that addresses both the acne treatment and skin appearance needs of these women

Study Design Skin Benefit Endpoints

Objective: 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% benzoyl peroxide; 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-assessment Enlarged pores by image analysis and subject self-assessment Skin barrier function (TEWL) Skin hydration (capacitance)

Study Wk -2 Timeline
Assess

Pre-Conditioning Cleanse with mild liquid cleanser AM, PM: Placebo Moisturizer w/3% glycerin/SPF15

Wk 0
~110 subjects ~110 subjects ~110 subjects

SA Regimen
AM SA Cleanser
Assess (1.8% salicylic acid)

BP Regimen
AM Cleanser
(non-acne)

Placebo
AM Cleanser
(non-acne)

Wk +4

SA Treatment
(1.5% salicylic acid)

BP Treatment
(2.5% benzoyl peroxide)

Sunscreen
(3%gly/SPF15)

AA Moisturizer
(5% niacinamide)

Sunscreen
(3% gly/SPF15)

Sunscreen
(3%gly/SPF15) Assess

Wk +8

PM
Assess

PM Cleanser BP Treatment 3% gly Moisturizer

PM Olay FFW 3%gly Moisturizer

Wk +12

SA Cleanser SA Treatment AA Moisturizer

Results Inflammatory Lesion Counts

Data was log transformed for analysis Reported data is back transformed There was substantial improvement in the placebo group

Both BP and the SA regimens significantly reduced the number of inflammatory 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

Texture and Pore Analysis

REAL 3.0 system

Results Skin Texture/Image Analysis

Texture benefit not driven by acne lesion resolution

The SA regimen significantly improved facial skin texture compared to the other two treatment regimens BPs impact was negative but not significant compared to placebo

Results Skin Texture Self-Assessments

Subjects graded their skin texture on a 0-10 pt continuous scale Absolute grades were given at each time point Lower number means less uneven (more even) texture Subjects could calibrate to their last grade

Subjects using the SA regimen noticed an improvement in their skin texture throughout the study This may be driven in part by clearance of their acne lesions

Results Pore Area Image Analysis

Pore reduction benefit not driven by acne lesion resolution

The SA regimen significantly reduced the detectable pore area compared to the other two treatment regimens BP treatment increased pore area but not significantly compared to placebo

Results Pore Size/Visibility Self Assessment

Subjects graded their pore size/visibility on a 0-10 pt continuous scale; poor to excellent

Significant benefits after 8 wks with the SA regimen and after 12 wks for BP Results not completely driven by improvements in acne lesions

Results Barrier Function (TEWL)

TEWL was measured on the cheek with most acne at baseline Triplicate readings were averaged

Vapometer

The SA regimen was similar to placebo with respect to barrier integrity Possible balancing effect of niacinamide (known to provide barrier integrity improvement) and salicylic acid BP regimen treatment significantly compromised barrier

Results Skin Hydration (Corneometer)

Hydration was measured via Corneometer on the cheek most broken out at baseline Triplicate readings were averaged

SA regimen treatment provided a significant hydration benefit early on compared 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

Conclusions
The SA regimen used in this study significantly reduced inflammatory acne lesions starting at 4 weeks treatment, compared to placebo The acne benefits from the SA regimen were comparable to those achieved 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 significantly reduced 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 skin benefits. The SA regimen provided both anti-acne efficacy and additional benefits for attributes related to skin aging. The latter benefits were not achieved with a 2.5% BP regimen.

This work was funded by P&G Beauty & Grooming