Efficacy and safety of adapalene 0.3%/benzoyl peroxide 2.5% topical gel in moderate and severe acne vulgaris
J Am Acad Dermatol
This study compared the efficacy and safety of adapalene 0.3%/benzoyl peroxide 2.5% (0.3% A/BPO) topical gel vs vehicle in subjects with moderate and severe acne (overall population [OP]), and in a subpopulation of the OP (severe acne subjects only) (severe population [SP]). The study also compared 0.3% A/BPO vs adapalene 0.1%/benzoyl peroxide 2.5% (0.1% A/BPO) topical gel in the SP. This multicenter, randomized, double-blind, parallel-group, vehicle- and active-controlled study included a total of 503 subjects. Subjects were randomized to apply 0.3% A/BPO (n = 217), 0.1% A/BPO (n = 217) or vehicle (n = 69) once daily for 12 weeks. The OP included subjects with moderate (investigator global assessment [IGA] = 3) and severe (IGA = 4) acne, while the SP consisted only of subjects with severe disease (IGA = 4). Coprimary efficacy endpoints included success rate (at least 2-grade improvement on IGA) and change in inflammatory (IN) and noninflammatory (NIN) lesion count from baseline to week 12. In the OP, 0.3% A/BPO was superior to vehicle in success rate (33.7% vs 11.0%), and changes in IN (-27.0 vs -14.4) and NIN lesion counts (-40.1 vs -18.4), as well as percent changes in IN (-68.7% vs -39.2%) and NIN lesion counts (-68.3% vs -37.3%, respectively; all P < .001). Similarly, in the SP, 0.3% A/BPO was superior to vehicle in success rate (31.9% vs 11.8%; P = .029), and changes in IN (-35.1 vs -15.4) and NIN lesion counts (-45.6 vs -17.2), as well as percent changes in IN (-74.4% vs -33.0%) and NIN lesion counts (-72.0% vs -30.7%, respectively; all P < .001). Of note, 0.3% A/BPO showed nonstatistically significant but positive numerical differences over 0.1% A/BPO in the SP of 11.4% (95% confidence interval [CI]: -0.5%, 23.2%) in success rate, and -3.25 [CI: -7.15, 0.64] and -2.51 [CI: -8.08, 3.06] for changes in IN and NIN lesion counts. In terms of safety, 0.3% A/BPO was well tolerated, with a similar local tolerability profile to that of 0.1% A/BPO. Treatment-related adverse events (AEs) (15 AEs in 12 subjects [5.5%] vs 2 AEs in 1 subject [0.5%], respectively) were mild to moderate in severity. Only 1 subject (0.2%) in the 0.3% A/BPO group discontinued treatment due to an AE (atopic dermatitis flare) and no serious AEs were reported. The 0.3% A/BPO topical gel showed superior efficacy to vehicle in the general population, with greater efficacy shown in subjects with severe acne. The safety profile of 0.3% A/BPO was acceptable and comparable to that observed for 0.1% A/BPO.