Linda Stein Gold1, James Q Del Rosso2, Leon Kircik3, Neal D Bhatia4, Deirdre Hooper5, Walter K Nahm6, Iain Stuart7. 1. Henry Ford Health System, Detroit, Michigan. 2. JDR Dermatology Research/Thomas Dermatology, Las Vegas, Nevada. 3. Icahn School of Medicine at Mount Sinai, New York, New York. 4. Therapeutics Clinical Research, San Diego, California. 5. Delricht Research, New Orleans, Louisiana. 6. University of California, San Diego School of Medicine, San Diego, California. 7. Foamix Pharmaceuticals, Inc, Bridgewater, New Jersey. Electronic address: iain.stuart@foamix.com.
Abstract
BACKGROUND: Efficacious topical medications for rosacea are needed. FMX103 1.5% is a novel topical minocycline foam that may have therapeutic benefits in treating rosacea while minimizing systemic adverse effects due to its topical route of delivery. OBJECTIVE: To determine the efficacy, safety, and tolerability of 12 weeks of treatment with FMX103 1.5% topical minocycline foam for papulopustular rosacea. METHODS: Two 12-week, phase 3, randomized, multicenter, double-blind, vehicle-controlled, 2-arm studies were performed in patients with moderate to severe papulopustular rosacea. RESULTS: Participants who received FMX103 1.5%, versus control individuals treated with vehicle, exhibited a significantly greater reduction in the number of inflammatory lesions (FX2016-11: -17.57 vs -15.65; P = .0031; FX2016-12: -18.54 vs -14.88; P < .0001) and higher rates of Investigator Global Assessment treatment success (FX2016-11: 52.1% vs 43.0%; P = .0273; FX2016-12: 49.1% vs 39.0%; P = .0077). No serious treatment-related treatment-emergent adverse events occurred. LIMITATIONS: The generalizability of these data from a controlled clinical trial should be examined in a real-world setting. CONCLUSIONS:FMX103 1.5% was efficacious for moderate to severe papulopustular rosacea and maintained a favorable safety profile.
RCT Entities:
BACKGROUND: Efficacious topical medications for rosacea are needed. FMX103 1.5% is a novel topical minocycline foam that may have therapeutic benefits in treating rosacea while minimizing systemic adverse effects due to its topical route of delivery. OBJECTIVE: To determine the efficacy, safety, and tolerability of 12 weeks of treatment with FMX103 1.5% topical minocycline foam for papulopustular rosacea. METHODS: Two 12-week, phase 3, randomized, multicenter, double-blind, vehicle-controlled, 2-arm studies were performed in patients with moderate to severe papulopustular rosacea. RESULTS:Participants who received FMX103 1.5%, versus control individuals treated with vehicle, exhibited a significantly greater reduction in the number of inflammatory lesions (FX2016-11: -17.57 vs -15.65; P = .0031; FX2016-12: -18.54 vs -14.88; P < .0001) and higher rates of Investigator Global Assessment treatment success (FX2016-11: 52.1% vs 43.0%; P = .0273; FX2016-12: 49.1% vs 39.0%; P = .0077). No serious treatment-related treatment-emergent adverse events occurred. LIMITATIONS: The generalizability of these data from a controlled clinical trial should be examined in a real-world setting. CONCLUSIONS: FMX103 1.5% was efficacious for moderate to severe papulopustular rosacea and maintained a favorable safety profile.
Authors: Linda Stein Gold; James Q Del Rosso; Leon Kircik; Neal D Bhatia; Deirdre Hooper; Walter Nahm; Iain Stuart Journal: J Clin Aesthet Dermatol Date: 2020-11-01
Authors: Esther J van Zuuren; Bernd W M Arents; Mireille M D van der Linden; Sofieke Vermeulen; Zbys Fedorowicz; Jerry Tan Journal: Am J Clin Dermatol Date: 2021-03-23 Impact factor: 7.403