Phase III Study of Benzoyl Peroxide 2.5% Lotion in Patients with Acne Vulgaris:

The efficacy and safety of benzoyl peroxide 2.5% lotion (BPO-L) in patients with acne vulgaris were evaluated in a randomized, vehicle-controlled, double-blind, parallel-group, multicenter study. In this study, patients with moderate acne vulgaris aged 12 to 49 years applied BPO-L or vehicle once daily for 12 weeks to the entire face after washing the face. A total of 222 randomized patients (109 in the BPO-L group and 113 in the vehicle group) received the study drug. The least squares mean percentage reduction in the primary endpoint of total lesion count (total number of inflammatory and non-inflammatory lesions) from baseline after 12 weeks of treatment was 63.0% in the BPO-L group and 26.5% in the vehicle group, indicating that BPO-L significantly reduced total lesion counts (P < 0.0001). The numbers of inflammatory and non-inflammatory lesions, secondary endpoints, were also significantly reduced (P < 0.0001 for both). The incidence of adverse events was 29.4% in the BPO-L group and 23.9% in the vehicle group. The incidence of adverse events related to the study drug was higher in the BPO-L group (11.9%) than in the vehicle group (6.2%). Most adverse events were mild and occurred on the sites to which the study drug was applied, and all recovered or improved with the exception of 3 cases that were classified as unrecovered. BPO-L was well tolerated in patients with acne vulgaris, and the total lesion count decreased from 2 weeks after the start of treatment. This finding suggests that BPO-L can expand the available treatment options for BPO that were previously confined to gel-only products and provide early and aggressive treatment for acne vulgaris. Study Registration Number jRCT2031200251.