A Randomized Controlled Tolerability Study to Evaluate Reformulated Benzoyl Peroxide Face Washes for Acne Vulgaris
April 2019 | Volume 18 | Issue 4 | Original Article | 350 | Copyright © April 2019
JoÃ£o P. Santos-Caetano MSc,a Matthew R. Cargill PhDb
aGlaxoSmithKline Consumer Healthcare, Scientific and Medical Affairs, Global Categories, SÃ£o Paulo, Brazil bGlaxoSmithKline Consumer Healthcare, Clinical Research â€“ Skin Health, Weybridge, UK
Introduction: This randomized, evaluator-blind, single-center, parallel-group study sought to evaluate the tolerability of two reformulated face washes containing benzoyl peroxide (BPO) in adults with mild to moderate acne vulgaris.
Methods: Healthy adults with mild to moderate acne vulgaris were randomly allocated (1:1:1) to one of two reformulated test products (containing BPO at a concentration of either 4% or 10%) or an older formulation containing 10% BPO (reference product), which they applied twice daily for 21Â±2 days. The primary tolerability assessment was clinical assessment of signs and symptoms of cutaneous irritation by a dermatologist. The primary outcome was the total dermatologist assessment score (maximum total assessment score=12, indicating the most severe skin irritation). Secondary assessments were ophthalmologist assessments, subject self-assessments, and adverse events.
Results: 133 adults were randomized and treated. The total dermatologist score changed by a mean of -0.08 (95% confidence interval [CI] -0.192, 0.038) from baseline to day 21 in the 4% BPO cleanser group, by 0.05 (95% CI -0.021, 0.121) in the 10% BPO cleanser group, and by -0.02 (95% CI -0.105, 0.059) in the reference product group. There was no clinically significant difference between the reference product and the 4% BPO cleanser or 10% BPO cleanser in the mean change from baseline. Mean changes from baseline in ophthalmologist assessment scores and subject self-assessment scores for the 4% and 10% BPO test products were also comparable to those of the reference product. Dermal responses were consistent with the known effects of topical BPO application and no serious safety issues were reported.
Discussion: There was no difference in the local tolerance profile of the reformulated BPO-containing face washes when compared with an older formulation. Study registration: www.gsk-clinicalstudyregister.com (study 206239).
J Drugs Dermatol. 2019;18(4):350-356.