Minocycline 1.5% foam for the topical treatment of moderate to severe papulopustular rosacea: Results of 2 phase 3, randomized, clinical trials - 26/02/20

Doi : 10.1016/j.jaad.2020.01.043

Linda Stein Gold, MD ^a, James Q. Del Rosso, DO ^b, Leon Kircik, MD ^c, Neal D. Bhatia, MD ^d, Deirdre Hooper, MD ^e, Walter K. Nahm, MD, PhD ^f, Iain Stuart, PhD ^g,^⁎
^a Henry Ford Health System, Detroit, Michigan
^b JDR Dermatology Research/Thomas Dermatology, Las Vegas, Nevada
^c Icahn School of Medicine at Mount Sinai, New York, New York
^d Therapeutics Clinical Research, San Diego, California
^e Delricht Research, New Orleans, Louisiana
^f University of California, San Diego School of Medicine, San Diego, California
^g Foamix Pharmaceuticals, Inc, Bridgewater, New Jersey

^∗Reprint requests: Iain Stuart, PhD, 520 US Highway 22, Ste 204, Bridgewater, NJ 08807.520 US Highway 22, Ste 204BridgewaterNJ08807

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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.

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Key words : double-blind clinical trial, facial, minocycline, papulopustular rosacea, phase 3, topical foam

Abbreviations used : AE, C_max, DRESS, IGA, study 11, study 12, TEAE

Plan

Methods

Study design

Eligibility criteria

Efficacy and safety endpoints

Statistical analysis

Results

Baseline characteristics and participant demographics

Efficacy

Safety and tolerability

Discussion

Conclusions

	Funding sources: Supported by Foamix Pharmaceuticals, Inc.
	Disclosure: Dr Stein Gold is an advisor, investigator, and consultant for Foamix and Galderma, an investigator for Novartis and Sol Gel, and an advisor and investigator for Ortho-Dermatologics. Dr Del Rosso is a consultant, advisor, and investigator for BioPharmX, Foamix, and Galderma, and a speaker for Galderma. Dr Bhatia served as an investigator for Foamix. Dr Hooper served as an investigator for Foamix, reported personal fees from DelRicht Research during the study, received honoraria from Allergan, Almirall Aesthetics, Aqua Pharmaceuticals, Galderma USA, Cutera, Inc, Ferndale, La Roche Posay, Pixacore, RBC Consultants (clarisonic), Revance, and Viviscal, and received other financial benefits from Actavis, Dermira, GlaxoSmithKline, Mylan, and Sol Gel. Dr Kircik is an investigator and consultant for Foamix. Dr Nahm is an investigator for Foamix. Dr Iain Stuart is an employee and stockholder at Foamix.
	IRB approval status: The study protocol (ClinicalTrials.gov identifier: NCT03142451) was approved by an institutional review board at each site.