Efficacy and safety of FMX103 (1.5% minocycline foam) in the treatment of moderate-to-severe papulopustular rosacea: Results from two Phase III randomized, multicenter, double-blind, vehicle-controlled studies
Stein Gold L, Del Rosso JQ, Bhatia ND, Hooper D, Nahm W, and Stuart I. Efficacy and safety of FMX103 (1.5% minocycline foam) in the treatment of moderate-to-severe papulopustular rosacea: Results from two Phase III randomized, multicenter, double-blind, vehiclecontrolled studies. J Clin Aesthet Dermatol 2019; 12(5):S32.
J Clin Aesthet Dermatol
Background/Objective: To determine the efficacy, safety, and local tolerability of FMX103 1.5% topical minocycline foam used for 12 weeks in the treatment of papulopustular rosacea. Methods: Two Phase III, randomized, multicenter, double-blind, vehicle-controlled, two-arm studies (Study FX2016-11 and Study FX2016-12) were conducted in subjects of 18 years or older of age with moderate-tosevere papulopustular rosacea. Subjects were randomized 2:1 to either FMX103 or vehicle treatment respectively and applied, or had applied for them, FMX103 foam or vehicle foam once daily to the face for 12 weeks. They were evaluated at baseline and Weeks 2, 4, 8, and 12. Coprimary efficacy endpoints were absolute change from baseline in inflammatory lesion count and the proportion of subjects with treatment success, defined as an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) with at least a two-grade improvement from baseline at Week 12. Safety evaluations included adverse events, vital signs, physical examination, laboratory investigations, and local tolerability assessment. Subject global assessment (SGA) and subject satisfaction were assessed by a questionnaire at Week 12. Results: A total of 1,522 subjects were enrolled in the two studies (Study FX2016-11, n=751; Study FX2016-12, n=771). At baseline, in Study FX2016-11 and FX2016-12, respectively, the mean inflammatory lesion count was 28.5 and 30.0 for the FMX103 treatment groups, and 29.0 and 30.2 for the vehicle treatment groups. Both studies met both coprimary endpoints. There were statistically significant reductions in number of inflammatory lesions from baseline with FMX103 (Study FX2016-11, -17.57 vs. -15.65, P=0.003; Study FX2016-12, -18.54 vs. -14.88; P<0.0001) and significantly higher rates of IGA treatment success versus vehicle (Study FX2016-11, 52.1 vs. 43.0%, P=0.027; Study FX2016-12, 49.1 vs. 39.0%, P=0.008). The most common treatment-emergent adverse event (TEAE) for both studies was upper respiratory tract infection. There were no serious treatment-related TEAEs. Overall, nine subjects across both studies discontinued due to a TEAE (FMX103, seven subjects; vehicle, two subjects). Conclusion: FMX103 appeared to be effective with a favorable safety profile for the treatment of moderate-to-severe papulopustular rosacea.