“FCD105 combines minocycline and adapalene, which are two leading agents for treating inflammatory and non-inflammatory comedonal acne lesions, respectively, in a convenient, foam-based product. We currently expect topline data from this study in mid-2020,” said David Domzalski, CEO of Foamix. “The initiation of this Phase 2 clinical trial for FCD105 is an important milestone for Foamix, as this would be our first follow-on product behind our lead product candidates, FMX101 for moderate to severe acne vulgaris, and FMX103, for the treatment of moderate-to-severe papulopustular rosacea.”

Study Design

The Phase 2 clinical trial is expected to enroll approximately 400 patients, aged 12 years and older, with moderate-to-severe acne vulgaris. This prospective, randomized, double-blind, vehicle-controlled trial will be conducted at multiple sites throughout the United States. Patients will be randomized to one of four treatment arms: FCD105 foam, 0.3% adapalene foam, 3% minocycline foam or vehicle foam and will self-apply their assigned treatment once daily for 12 weeks. The study design follows current regulatory standards in evaluating the safety and efficacy of combination products of this type.

The primary endpoints are: 1) the proportion of patients achieving success at week 12 based on an Investigator’s Global Assessment (success is defined as a score of “clear” or “minimal” and at least a 2 category improvement from baseline), 2) the mean change from baseline in inflammatory lesion counts in each treatment group at week 12, and 3) the mean change from baseline in non-inflammatory lesion counts in each treatment group at week 12. Safety evaluation will include reported adverse events, skin tolerability assessments, physical examinations and vital signs.