Last updated on October 2016

A Randomized, Double-Blind Study to Compare the Efficacy, Safety and Long-Term Safety of Topical Administration of FMX-101 for 1 Year in the Treatment of Moderate-to-Severe Acne Vulgaris


Brief description of study

A Randomized, Double-Blind Study to Compare the Efficacy, Safety and Long-Term Safety of Topical Administration of FMX-101 for 1 Year in the Treatment of Moderate-to-Severe Acne Vulgaris

Detailed Study Description

The main purpose of this study is to evaluate the efficacy, safety and long-term safety of a once daily topical application of FMX-101 Foam in subjects with moderate to severe acne. The first 12 weeks of the study involves randomized, double-blind dosing with FMX-101, 4% or matching vehicle (double-blind means neither the subject nor the study personnel knows if the subject is getting the drug or the vehicle). Subjects who successfully complete the 12-week double blind portion of the study may be offered the opportunity to continue in the trial for up to an additional 40 weeks (for a total of 1 year) and receive open-label FMX 101, 4%.

Clinical Study Identifier: TX145790

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Andrew Frisina

Schweiger Dermatology, PLLC
New York, NY USA
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