A multicenter, randomized, placebo-controlled, double-blind clinical trial of a novel formulation of 5% minoxidil topical foam versus placebo in the treatment of androgenetic alopecia in men - 19/08/11
, David Whiting, MD b, Wilma Bergfeld, MD c, Jeffrey Miller, MD d, Maria Hordinsky, MD e, Rita Wanser, BS f, Paul Zhang, PhD f, Bruce Kohut, DMD f
Correspondence to: Elise A. Olsen, MD, Box 3294, Duke University Medical Center, Durham, NC 27516.Abstract |
Background |
An alternative to currently marketed topical minoxidil solutions is desirable.
Objective |
To assess the efficacy and safety of a new 5% minoxidil topical formulation in a propylene glycol–free foam vehicle in men with androgenetic alopecia (AGA).
Methods |
This was a 16-week, double-blind, placebo-controlled trial of 5% minoxidil topical foam (MTF) in 352 men, 18 to 49 years old. At week 16, 143 subjects continued on an open-label phase to collect 52 weeks of safety information on 5% MTF.
Results |
At week 16 compared with baseline, there was a statistically significant increase in (1) hair counts in the 5% MTF group versus placebo (P < .0001) and (2) subjective assessment of improved hair loss condition (P < .0001) in the 5% MTF group versus placebo. The 5% MTF was well tolerated over a 52-week period.
Limitations |
There was no collection of efficacy data beyond 16 weeks.
Conclusions |
We believe that 5% MTF is a safe and effective treatment for men with AGA.
Le texte complet de cet article est disponible en PDF.Abbreviations used : AEs, AGA, FDA, GPR, MPHL, MTF, MTS, OTC, PK, TAHC
Plan
| Supported by Pfizer Inc. |
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| Disclosure: Drs Olsen, Whiting, Bergfeld, Miller, and Hordinsky received study grants; Drs Olsen and Miller also received other grant support. Drs Olsen, Whiting, Bergfeld, Miller, and Hordinsky have served as consultants. Ms Wanser and Drs Zhang and Kohut were all employees of Pfizer, Inc at the time the study was conducted and during the preparation of the manuscript. |
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| Study results were presented as a poster at the Fall Clinical Dermatology Conference in Las Vegas, Nevada, October 6-9, 2006 and were presented at the Intercontinental meeting of the Hair Research Societies in Vancouver, British Columbia, June 13-16, 2007. |
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| Reprints not available from the authors. |
Vol 57 - N° 5
P. 767-774 - novembre 2007 Retour au numéro
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