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Journal of the American Academy of Dermatology
Sous presse. Epreuves corrigées par l'auteur. Disponible en ligne depuis le vendredi 24 janvier 2020
Doi : 10.1016/j.jaad.2019.05.078
accepted : 27 May 2019
Efficacy and safety of a novel topical minocycline foam for the treatment of moderate to severe acne vulgaris: A phase 3 study
 

Tooraj Joseph Raoof, MD a, Deirdre Hooper, MD b, Angela Moore, MD c, d, Martin Zaiac, MD e, f, Tory Sullivan, MD g, Leon Kircik, MD h, Edward Lain, MD i, Jasmina Jankicevic, MD j, Iain Stuart, PhD j,
a T. Joseph Raoof MD Inc/Encino Research Center, Encino, CA 
b Delricht Research, New Orleans, LA 
c Arlington Research Center, Arlington, TX 
d Baylor University Medical Center, Dallas, TX 
e Department of Dermatology, Herbert Wertheim College of Medicine, Florida International University, Miami, FL 
f Greater Miami Skin and Laser Center, Miami Beach, FL 
g Sullivan Dermatology, North Miami Beach, FL 
h Icahn School of Medicine at Mount Sinai, New York, NY 
i Austin Institute for Clinical Research, Austin, TX 
j Foamix Pharmaceuticals, Inc., Bridgewater, NJ 

Correspondence to: Iain Stuart, PhD, Foamix Pharmaceuticals, Inc, 520 US Highway 22, Ste 204, Bridgewater, NJ 08807.Foamix Pharmaceuticals, Inc520 US Highway 22, Ste 204BridgewaterNJ08807
Abstract
Background

FMX101 4% topical minocycline foam has been shown to be an effective and safe treatment for acne vulgaris (AV).

Objective

To further evaluate the efficacy and safety of FMX101 4% in treating moderate to severe acne vulgaris.

Methods

A 12-week, multicenter, randomized (1:1), double-blind, vehicle-controlled study was conducted. Coprimary end points were the absolute change in inflammatory lesion count from baseline and the rate of treatment success (Investigator's Global Assessment score of 0 or 1 with a ≥2-grade improvement).

Results

There were 1488 participants in the intent-to-treat population. The FMX101 4% group had significantly greater reductions in the number of inflammatory lesions from baseline (P  < .0001) and a greater rate of treatment success based on Investigator's Global Assessment (P  < .0001) versus the foam vehicle group at week 12. FMX101 4% was generally safe and well tolerated.

Limitations

The efficacy and safety of FMX101 4% were not characterized in participants with mild AV.

Conclusion

FMX101 4% topical minocycline foam was effective and safe for the treatment of moderate to severe AV.

The full text of this article is available in PDF format.

Key words : acne vulgaris, clinical study, efficacy, foam, minocycline, randomized, safety, topical administration

Abbreviations used : AV, CI, CK, IGA, LSM, TEAE, AE, ITT



 Funding sources: Sponsored by Foamix Pharmaceuticals, Inc.
 Disclosure: Drs Raoof, Hooper, Zaiac, Sullivan, Lain, and Moore served as investigators for Foamix Pharmaceuticals. Dr Kircik is an investigator and consultant for Foamix Pharmaceuticals. Dr Jankicevic is a consultant for Foamix Pharmaceuticals. Dr Stuart is an employee and stockholder at Foamix Pharmaceuticals.



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