Abstract
Abstract not available.
Highlights
– Overall, the FMX101 4% group exhibited a significantly greater reduction in inflammatory lesions from baseline at Week 12 compared with the vehicle group
Analyses were performed on the integrated data set to characterize the efficacy of FMX101 4% in treating acne in predefined subgroups of subjects
– Consistent with results from the pooled population, FMX101 4% resulted in significantly greater reductions in inflammatory lesions at all assessed timepoints in subgroups of subjects that were separated by baseline disease severity, sex, age, and race
Summary
Acne vulgaris is a chronic, inflammatory skin disorder that affects most of the population at some point in their lifetime[1]. Oral minocycline and doxycycline are considered first-line therapy for the treatment of moderate-to-severe acne, but they are associated with potentially serious systemic side effects[2]. FMX101 4% is the first stable, topical foam formulation of minocycline and has been FDA-approved for the daily treatment of acne. The efficacy of FMX101 4% in treating acne has previously been demonstrated in 3 double-blind, vehicle-controlled, 12-week, Phase 3 clinical trials (FX2014-04, FX2014-05, and FX2017-22)[3-4]. Objective: To provide an integrated summary of efficacy of FMX101 4% versus vehicle foam for a pooled population of ~2500 subjects and for predefined subgroups of subjects that differ according to baseline disease severity, sex, age, and race
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