A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne

Summary

This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne vulgaris.

Timeline

Start

2016-05

Primary completion

2017-10-13

Completion

2017-10-13

Outcome

Met primary endpoint

registry analysis (superiority test); FMX-101, 4% Minocycline Foam vs Vehicle Foam; p = 0.0051; Mean Difference (Final Values) 3.15 (95% CI 0.95 to 5.35); ANCOVA NCT02815280 ↗

registry analysis (superiority test); FMX-101, 4% Minocycline Foam vs Vehicle Foam; p = 0.0424; Risk ratio 1.88 (95% CI 1.02 to 3.46); Mantel Haenszel NCT02815280 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Minocycline	Small molecule	4 %	Topical

Indications