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

Elise A. Olsen, David Whiting, Wilma Bergfeld, Jeffrey Miller, Maria Hordinsky, Rita Wanser, Paul Zhang, Bruce Kohut

Research output: Contribution to journalArticle

110 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)767-774
Number of pages8
JournalJournal of the American Academy of Dermatology
Volume57
Issue number5
DOIs
StatePublished - Nov 1 2007

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Minoxidil
Alopecia
Placebos
Clinical Trials
Therapeutics
Safety
Propylene Glycol
Hair

All Science Journal Classification (ASJC) codes

  • Dermatology

Cite this

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title = "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",
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.",
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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. / Olsen, Elise A.; Whiting, David; Bergfeld, Wilma; Miller, Jeffrey; Hordinsky, Maria; Wanser, Rita; Zhang, Paul; Kohut, Bruce.

In: Journal of the American Academy of Dermatology, Vol. 57, No. 5, 01.11.2007, p. 767-774.

Research output: Contribution to journalArticle

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AU - Olsen, Elise A.

AU - Whiting, David

AU - Bergfeld, Wilma

AU - Miller, Jeffrey

AU - Hordinsky, Maria

AU - Wanser, Rita

AU - Zhang, Paul

AU - Kohut, Bruce

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