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
João P. Santos-Caetano MSc,a Matthew R. Cargill PhDb
aGlaxoSmithKline Consumer Healthcare, Scientific and Medical Affairs, Global Categories, São Paulo, Brazil bGlaxoSmithKline Consumer Healthcare, Clinical Research – Skin Health, Weybridge, UK
Abstract
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 21±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.
INTRODUCTION
Acne vulgaris is a chronic skin condition, affecting the pilosebaceous unit of the skin, with an estimated global prevalence of 9.4%.1,2 It affects both sexes and all ethnicities and has a peak incidence in the teenage years.3 Several pathophysiological mechanisms are associated with it, including increased sebum production, abnormal keratinization, proliferation of Propionibacterium acnes (P. acnes), and inflammatory cascades.1,4Many different pharmaceutical treatments, both topical and systemic, and physical modalities such as lasers and photodynamic therapy, are available to control acne.5,6 Recommended first-line treatments are determined by the severity of acne and the type of lesions.5 Topical preparations, which include benzoyl peroxide (BPO), retinoids, or antibiotics, are the mainstay of treatment for mild to moderate acne.5 Topical products containing more than one active ingredient, eg, BPO and retinoid, may have greater efficacy than single-agent products and are increasingly popular.7,8 Treatment of severe acne requires systemic treatments, such as oral antibiotics and oral retinoids, sometimes with adjunctive topical treatment.5 Appropriate skin care techniques may also support the secondary prevention of lesions.9,10Topical products containing BPO as an active ingredient (washes, foams, creams, and gels) are widely used for acne vulgaris and vary in concentration from 2.5% to 10% BPO.5 BPO is a bactericidal oxidizing agent for P. acnes.11 BPO is potentially irritating to skin, but it is Generally Regarded as Safe and Effective (GRASE) in over-the-counter topical products for acne.10,12,13Two previously marketed BPO-containing face washes have been reformulated to improve their chemical properties, sensory attributes, and manufacturing cycle times, and to reduce
