Galderma announced positive Phase 3 results for adapalene 0.3%/benzoyl peroxide 2.5% (0.3% A/BPO) topical gel, an antibiotic-free investigational drug with a higher concentration of adapalene than currently available therapies.
The multicenter, randomized, double-blind, parallel-group, vehicle- and active-controlled study assessed the efficacy and safety of 0.3% A/BPO in subjects with moderate and severe acne as well as in the subgroup of subjects with severe acne only. Participants were randomized to apply 0.3% A/BPO, 0.1% A/BPO, or vehicle gel once daily for 12 weeks. The co-primary efficacy endpoints were success rate, change in inflammatory (IN) lesion count, and change in non-inflammatory (NIN) lesion count.
The co-primary efficacy endpoints were met in both the overall population (moderate and severe acne) and in the severe population (severe disease only).
In the overall population, 0.3% A/BPO demonstrated superior success rate to vehicle (33.7% vs 11.0%). In addition, superior changes in IN lesions (-27.0 vs -14.4) and NIN lesion counts (-40.1 vs -18.4) and percent changes in IN lesions (-68.7% vs -39.2%) and NIN lesion counts were observed (-68.3% vs -37.3%, respectively) (all P<0.001).
In the severe population, 0.3% A/BPO was superior to vehicle in success rate (31.9% vs 11.8%; P=0.029). In addition, superior changes in IN lesion (-35.1 vs -15.4) and NIN lesion counts (-45.6 vs -17.2), as well as in percent changes in IN lesions (-74.4% vs -33.0%) and NIN lesion counts were documented (-72.0% vs -30.7%, respectively).
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