A fixed-dose combination gel with adapalene 0.1% and benzoyl peroxide (BPO) 2.5% recently has been developed for the treatment of acne vulgaris. In this multicenter, randomized, double-blind, parallel-group, active- and vehicle-controlled study conducted at 60 centers in the United States, Puerto Rico, and Canada, we assessed the efficacy and safety of adapalene-BPO combination gel in comparison with adapalene and BPO monotherapies as well as the gel vehicle. Participants with moderate facial acne vulgaris (rated 3 on the 5-point investigator global assessment of acne severity scale) were recruited and randomized to receive once-daily treatment with adapalene-BPO combination gel, adapalene monotherapy, BPO monotherapy, or gel vehicle for 12 weeks. They were assessed for success rate (the percentage of participants with investigator global assessment of acne severity rated clear or almost clear) and percentage change in inflammatory lesion (IL), noninflammatory lesion (NIL), and total lesion counts. Of the 1668 participants enrolled, 1429 (85.7%) completed the study. At study end point, adapalene-BPO combination gel showed a significantly higher success rate (P < or = .006) and a greater percentage reduction in all acne lesion counts (P < or = .017) compared with the other treatment groups. A significant early treatment effect of adapalene-BPO combination gel at week 1 compared with adapalene monotherapy and vehicle also was observed for all lesion count reductions (P<.001). The safety of adapalene-BPO combination gel was comparable with adapalene and BPO monotherapies and vehicle. In a large clinical trial, the adapalene-BPO fixed-dose combination gel has shown superiority in efficacy compared with adapalene and BPO monotherapies and vehicle, with an early onset of efficacy and a good safety profile.
Trial registration: ClinicalTrials.gov NCT00422240.