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

Benzoyl peroxide ( BPO ) as an anti‐acne medication is not yet approved in J apan. This study evaluated the efficacy and safety of a once‐daily topical application of BPO 3% gel versus an inert vehicle gel in J apanese 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 I nvestigator's S tatic G lobal A ssessment ( 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 J apanese acne patients.