Is benzoyl peroxide 3% topical gel effective and safe in the treatment of acne vulgaris in Japanese patients? A multicenter, randomized, double‐blind, vehicle‐controlled, parallel‐group study

Abstract

Benzoyl peroxide (BPO) as an anti-acne medication is not yet approved in Japan. This study evaluated the efficacy and safety of a once-daily topical application of BPO 3% gel versus an inert vehicle gel in Japanese acne patients. Three hundred and sixty patients were randomized to receive BPO 3% or vehicle for 12 weeks. The primary efficacy end-point was absolute change in number of total lesions (TL) from baseline to week 12 to demonstrate the superiority of BPO 3% versus vehicle. Secondary efficacy end-points were absolute and percent change in TL, inflammatory lesions (IL), non-inflammatory lesions (non-IL) and Investigator's Static Global Assessment (ISGA). Change in TL counts from baseline to week 12 for BPO 3% was superior to vehicle (difference, À21.0; P < 0.001). Absolute and percent reductions in TL, IL and non-IL counts were greater for BPO 3% at all study visits. The proportion of patients with improvement in ISGA scores was significantly higher with BPO 3% than with vehicle from week 2. All adverse events were mild or moderate. Adverse drug-related reactions were higher for BPO 3% (30%) than with vehicle (5%). Local tolerability scores of grade 1 or more (slight to moderate) were more frequent with BPO 3% than vehicle with the most significant differences observed in dryness (56% vs 27% at week 1-4), peeling (19% vs 9% at week 1-2) and burning/stinging (58% vs 15% at week 1-12). These results indicate that BPO 3% is effective while maintaining a favorable safety and tolerability profile in Japanese acne patients.

Five‐day study to judge the short‐term effect of a benzoyl peroxide 3% gel on acne lesions

“…In these 12‐week studies, the product significantly reduced lesion counts and global assessment scores relative to vehicle with once‐daily application. One of the studies included a 1‐week evaluation; at that time, the reduction in lesion counts for the BPO 3% gel versus vehicle was significant …”

“…Although BPO and SA products have a history of use for acne treatment and enjoy monograph status in certain countries, confirming products’ efficacy is nonetheless important and provides consumers with additional assurance of claimed benefits. The BPO 3% gel used in this study was previously tested in two large, multicenter, vehicle‐controlled efficacy studies among a diverse subject population . In these 12‐week studies, the product significantly reduced lesion counts and global assessment scores relative to vehicle with once‐daily application.…”

“…However, neither of these factors is believed important to the outcome observed here. The formulation and application frequency of the BPO 3% gel were identical in this study and the earlier, full‐efficacy studies . The formulation of the SA 2% gel used in this study is believed comparable to that used in the reported studies.…”

Clinical efficacy and safety of benzoyl peroxide for acne vulgaris: Comparison between Japanese and Western patients

“…reviewed and investigated the data from clinical studies conducted in Western countries in patients with acne vulgaris using BPO. In the meantime, in Japan, BPO was approved in 2014 for the treatment of acne vulgaris and has been on the market since 2015, and therefore clinical data of Japanese patients has only recently become available . This article reviews the efficacy and safety profiles of BPO, and compares the results of clinical studies between Japanese and Western patients.…”

In Vitro Anti-inflammatory and Antimicrobial Activities of Azithromycin After Loaded in Chitosan- and Tween 20-Based Oil-in-Water Macroemulsion for Acne Management

“…This indicates that treatments which are aimed solely at reduction in numbers of P. acnes organisms are generally not very effective in long-term management of acne. Hence, the acne armamentarium contains many different therapeutic options, including topical benzoyl peroxide, topical and oral antibiotics, topical and oral retinoids, and hormonal agents (2,5). However, topical treatment with antibiotic alone (6) or in combination with other antiacne agents remains as the first-line therapy to manage mild and moderate acne (7).…”