A 3-PRODUCT SALICYLIC ACID REGIMEN EFFECTIVELY TREATS ACNE VULGARIS IN POST- ADOLESCENT WOMEN

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1 A 3-PRODUCT SALICYLIC ACID REGIMEN EFFECTIVELY TREATS ACNE VULGARIS IN POST- ADOLESCENT WOMEN J. R. Kaczvinsky 1, C. E. Mack 1, L. L. Griffin 1, J. Li 1, R. A. Rose-Mansfield 1, S. C. Weitz 1, M. J. Marmor 1, D. S. Berson MD 2, S. H. Weinkle MD 3 and D. Day MD 4 1 The Procter & Gamble Company, Cincinnati, OH USA 2 Cornell University, Ithaca, NY USA 3 University of South Florida, Tampa, FL USA 4 New York University, New York, NY USA Poster FC02-03

2 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

3 Study Design Acne Endpoints Objectives: 1. Compare the efficacy of a 3-product salicylic acid (SA) acne regimen versus a positive control regimen (2.5% benzoyl peroxide; BP) and a placebo regimen for improving acne vulgaris in post-adolescent women. 2. Compare subject tolerance to each regimen treatment. 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) Measures: Baseline and after 4, 8, and 12 weeks treatment Primary efficacy: Inflammatory lesion count by dermatologist Secondary efficacy: Total lesion count by dermatologist Global acne grade by dermatologist Tolerance: Erythema/dryness dermatologist grading Subject sensory responses

4 Study Timeline Wk -2 Pre-Conditioning Cleanse with mild liquid cleanser AM, PM: Placebo Moisturizer w/3% glycerin/spf15 Assess Wk 0 ~110 subjects ~110 subjects ~110 subjects SA Regimen BP Regimen Placebo AM AM AM Assess Assess Wk +4 Wk +8 SA Cleanser (1.8% salicylic acid) SA Treatment (1.5% salicylic acid) AA Moisturizer (5% niacinamide) Sunscreen (3%gly/SPF15) Cleanser (non-acne) BP Treatment (2.5% benzoyl peroxide) Sunscreen (3% gly/spf15) Cleanser (non-acne) Sunscreen (3%gly/SPF15) PM PM PM Assess Wk +12 SA Cleanser SA Treatment AA Moisturizer Cleanser BP Treatment 3% gly Moisturizer Olay FFW 3%gly Moisturizer

5 Acne Grading 0 Clear Residual hyperpigmentation and erythema may still be present Right Lesion Counts Left 1 Almost Clear A few scattered comedones and a few (less than five) small papules I III V II IV VI 2 Mild Some comedones and/or papules and pustules 3 Moderate Numerous comedones and/or papules and pustules 4 Severe Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts Subjects had to have at least 3 inflammatory lesions 5 Very Severe Highly inflammatory acne covering the face; with nodules and cysts present.

6 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

7 Results Total Lesion Counts Data was log transformed for analysis Reported data is back transformed There was substantial improvement in the placebo group The BP regimen significantly reduced lesions relative to placebo at all time points The SA regimen gave a significant benefit at 8 wks, directional benefit after 12 wks 12 wk reductions were ~42% for SA regimen and ~48% for BP regimen

8 Results Global Severity Grade Both the SA regimen and the BP regimen significantly improved acne compared to placebo after 8 and 12 weeks. More subjects improved on the SA and BP regimens than on placebo

9 Results Clinical Redness/Dryness 0-6 scale Erythema was generally low and improved over time, with no treatment differences (data not shown) BP was significantly more drying relative to the other treatments during the first 4 weeks of use, though the overall magnitude of dryness was modest

10 Results Sensory Attributes Higher incidences of stinging, burning and itching were observed with the BP and SA regimens than placebo However, the majority of sensations were reported as mild in intensity by the subjects Subjects had not been calibrated for sensory detection If only clinically relevant intensities were considered, the SA regimen was essentially equal to placebo and a bit milder than the BP regimen

11 Conclusions The SA regimen used in this study significantly improved acne in post-adolescent women with 8 or more weeks of treatment and inflammatory acne starting at 4 weeks treatment. The SA treatment improved acne significantly better than a placebo treatment. The acne benefits from the SA regimen were comparable to those achieved with twice daily use of 2.5% benzoyl peroxide. The SA regimen was well tolerated overall, producing no overt irritation and a sensory profile comparable to placebo and comparable to or better than that with a 2.5% BP regimen.

12 This research was funded by P&G Beauty & Grooming

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