title: 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, -21.0; 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.
authors.affiliation: Department of Dermatology, Tokyo Women's Medical University, Tokyo, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Kawashima
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Hashimoto
authors.forename: Alessandra B
authors.initials: AB
authors.lastname: Alio Sáenz
authors.forename: Makoto
authors.initials: M
authors.lastname: Ono
authors.forename: Masahiro
authors.initials: M
authors.lastname: Yamada
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy*; D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D044466:Asian People; D001585:Benzoyl Peroxide / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D005782:Gels; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D003879:Dermatologic Agents; D005782:Gels; D001585:Benzoyl Peroxide
keywords: Japanese patients; acne vulgaris; benzoyl peroxide 3% gel; safety; topical therapy