A Study (Study 1) to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam in the Treatment of Facial Papulopustular Rosacea

Summary

The primary objectives of this study are to determine the efficacy and safety of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea.

Timeline

Start

2017-06-02

Primary completion

2018-08-31

Completion

2018-09-28

Outcome

Met primary endpoint

registry analysis (superiority test); FMX103 1.5% vs Vehicle Foam; p = 0.0031; Mean Difference (Final Values) 2.21 (95% CI 0.75 to 3.68); ANCOVA NCT03142451 ↗

registry analysis (superiority test); FMX103 1.5% vs Vehicle Foam; p = 0.0273; Risk Ratio (RR) 1.210 (95% CI 1.022 to 1.434); Cochran-Mantel-Haenszel NCT03142451 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Minocycline	Small molecule	1.5 %	Topical
Subject	Minocycline	Small molecule	7.5 mg	Topical

Indications