Galderma Laboratories announced positive Phase 3 trial results of an investigational adapalene 0.3%/benzoyl peroxide 2.5% (0.3% A/BPO) topical gel for the treatment of acne at the annual meeting of the American Academy of Dermatology (AAD) in March. The antibiotic-free drug, which is currently being evaluated by the U.S. Food and Drug Administration (FDA), includes a higher concentration of adapalene than Galderma’s Epiduo (adapalene /benzoyl peroxide) Gel, 0.1%/2.5%.
For the multicenter, randomized, double-blind, parallel-group, vehicle- and active-controlled study, 503 subjects (ages 12 years and older) were treated with 0.3% A/BPO, 0.1% A/BPO, or vehicle gel, once daily for 12 weeks. Results showed that the 0.3% A/BPO arm demonstrated a superior success rate compared to vehicle (33.7% vs. 11.0%) in patients with moderate and severe acne, and a success rate of 31.9% vs. 11.8% in patients with severe acne only.
Response was gauged using the investigator global assessment (IGA) that organizes acne into five categories: 0 = clear skin; 1 = almost clear skin; 2 = mild acne severity; 3 = moderate acne severity; 4 = severe acne. Success rate was defined as the percentage of subjects with an IGA of clear/almost clear skin; patients with moderate acne had to experience at least a 2-grade improvement at week 12.
“This phase 3 pivotal trial, which observed a fixed-dose combination of adapalene, successfully met its two endpoints consisting of superior efficacy compared to vehicle in the overall patient population (patients with moderate and severe acne), and greater efficacy in the sub-population (patients with severe acne only),” explained Jonathan Weiss, MD, of Gwinnett Dermatology, PC & Gwinnett Clinical Research Center and lead study author. “In other acne studies, the criteria for success rates is typically only a 2-grade improvement; however, in this study, which observed moderate and severe subjects, participants with severe acne had to obtain clear/almost clear skin and a 3-grade IGA improvement, further demonstrating the effectiveness of this treatment.”