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. 2020 Nov;13(11):44-49.
Epub 2020 Nov 1.

Open-label Extension Study Evaluating Long-term Safety and Efficacy of FMX103 1.5% Minocycline Topical Foam for the Treatment of Moderate-to-Severe Papulopustular Rosacea

Linda Stein Gold  1   2   3   4   5   6   7 , James Q Del Rosso  1   2   3   4   5   6   7 , Leon Kircik  1   2   3   4   5   6   7 , Neal D Bhatia  1   2   3   4   5   6   7 , Deirdre Hooper  1   2   3   4   5   6   7 , Walter Nahm  1   2   3   4   5   6   7 , Iain Stuart  1   2   3   4   5   6   7
Affiliations

Open-label Extension Study Evaluating Long-term Safety and Efficacy of FMX103 1.5% Minocycline Topical Foam for the Treatment of Moderate-to-Severe Papulopustular Rosacea

Linda Stein Gold et al. J Clin Aesthet Dermatol. 2020 Nov.

Abstract

BACKGROUND: Efficacy and safety of FMX103 1.5% for papulopustular rosacea were previously demonstrated in two 12-week, Phase 3 studies. OBJECTIVE: We sought to evaluate the safety and efficacy of FMX103 1.5% foam for up to 52 weeks of treatment. METHODS: Following the completion of two 12-week, double-blind, vehicle-controlled, Phase 3 studies, subjects were invited to enter a 40-week open-label extension study in which all subjects applied FMX103 1.5% once daily. Efficacy endpoints were the reduction in inflammatory lesions and the rate of IGA treatment success from the double-blind baseline. Safety assessments included adverse events, vital signs, laboratory tests, and facial tolerability signs and symptoms. RESULTS: The favorable safety profile of FMX103 1.5% observed in the double-blind studies was maintained over extended treatment lasting up to one year. There were no serious treatment-related adverse events. Long-term treatment with FMX103 1.5% was associated with a greater than 82-percent reduction in inflammatory lesions from baseline and with over 79 percent of subjects achieving treatment success. At the end of the open-label treatment period, over 82 percent of subjects indicated they were overall "satisfied" or "very satisfied" with FMX103 1.5%. All facial local tolerability symptoms improved through Week 52. LIMITATIONS: Due to the nature of the open-label study, lacking a vehicle-treated control, no statistical comparisons can be made. CONCLUSION: FMX103 1.5% demonstrated a favorable safety and tolerability profile for up to 52 weeks. Long-term efficacy was demonstrated by progressive reductions in inflammatory lesions and increasing IGA treatment success, suggesting that FMX103 1.5% may be a suitable option for the treatment for papulopustular rosacea.

Keywords: minocycline; open-label; papulopustular rosacea; phase 3 clinical trial; safety; topical therapy.

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Conflict of interest statement

FUNDING:This study was sponsored by Foamix Pharmaceuticals Ltd., a wholly owned subsidiary of VYNE Therapeutics Inc. DISCLOSURES:Dr. Stein Gold is an advisor and investigator for VYNE Therapeutics Inc, Galderma, LEO Pharma, Novartis, and Valeant and is an investigator for Janssen, AbbVie, and Solgel. Dr. Del Rosso is a consultant for Aclaris, Almirall, Athenex, Cutanea, Dermira, EPI Health, Ferndale, Galderma, Genentech, LEO Pharma, VYNE Therapeutics Inc, Novan, Ortho, Pfizer, Promius, Sanofi/Regeneron, SkinFix, and SunPharma; he has received research support from Aclaris, Almirall, Athenex, Botanix, Celgene, Cutanea, Dermira, Galderma, Genentech, LEO Pharma, VYNE Therapeutics Inc, Novan, Ortho, Promius, Regeneron, SunPharma, and Thync; he receives honoraria from Aclaris, Celgene, Galderma, Genentech, LEO Pharma, Novartis, Ortho, Pfizer, Promius, Sanofi/Regeneron, and SunPharma; and he participates in speakers bureaus for honoraria from Aclaris, Celgene, Galderma, Genentech, LEO Pharma, Novartis, Ortho, Pfizer, Promius, Sanofi/Regeneron, and SunPharma. Dr. Kircik is an investigator and consultant for VYNE Therapeutics Inc. Dr. Bhatia is an investigator and consultant for VYNE Therapeutics Inc. Dr. Deirdre Hooper served as an investigator for VYNE Therapeutics Inc; she reports personal fees from DelRicht Research during the conduct of the study; honoraria from Allergan, Almirall Aesthetics, Aqua Galderma USA, Cutera Inc., Ferndale, La Roche Posay, Pixacore, RBC Consultants (clarisonic), Revance, and Viviscal; and other financial benefits from Actavis, Dermira, GSK, Mylan, and Sol Gel. Dr. Nahm is an investigator for VYNE Therapeutics Inc. Dr. Stuart is an employee and stockholder at VYNE Therapeutics Inc.

Figures

FIGURE 1.
FIGURE 1.
Summary of subject disposition; DB: double-blind study; OLE: open-label extension
FIGURE 2.
FIGURE 2.
Efficacy endpoints: Absolute and percent change from double-blind baseline in inflammatory lesions, and IGA treatment success throughout the study duration
See this image and copyright information in PMC

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