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Minocycline 1.5% Foam for the Topical Treatment of Moderate-to-Severe Papulopustular Rosacea: Results of Two Phase 3, Randomized, Clinical Trials.

J Am Acad Dermatol. 2020 Jan 28;:

Authors: Gold LS, Del Rosso JQ, Kircik L, Bhatia ND, Hooper D, Nahm WK, Stuart I

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 side effects due to its topical route of delivery.
OBJECTIVE: 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: Subjects who received FMX103 1.5%, vs vehicle-treated controls, 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.
CONCLUSION: FMX103 1.5% was efficacious for moderate-to-severe papulopustular rosacea, while maintaining a favorable safety profile.

PMID: 32004648 [PubMed - as supplied by publisher]

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