A Study (Study 2) 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

2017-06-01

Primary completion

2018-07-02

Completion

2018-07-31

Outcome

Met primary endpoint

registry analysis (superiority test); FMX103 1.5% vs Vehicle Foam; p <0.0001; Mean Difference (Final Values) 3.85 (95% CI 2.16 to 5.54); ANCOVA NCT04608500 ↗

registry analysis (superiority test); FMX103 1.5% vs Vehicle Foam; p = 0.0077; Risk Ratio (RR) 1.263 (95% CI 1.064 to 1.499); Cochran-Mantel-Haenszel NCT04608500 ↗

Drugs

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

Indications