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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.
J Am Acad Dermatol. 2007 Nov; 57(5):767-74.JA

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.

Authors+Show Affiliations

Duke University Medical Center, Durham, North Carolina 27516, USA. olsen001@mc.duke.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17761356

Citation

Olsen, Elise A., et al. "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." Journal of the American Academy of Dermatology, vol. 57, no. 5, 2007, pp. 767-74.
Olsen EA, Whiting D, Bergfeld W, et al. 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. J Am Acad Dermatol. 2007;57(5):767-74.
Olsen, E. A., Whiting, D., Bergfeld, W., Miller, J., Hordinsky, M., Wanser, R., Zhang, P., & Kohut, B. (2007). 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. Journal of the American Academy of Dermatology, 57(5), 767-74.
Olsen EA, et al. 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. J Am Acad Dermatol. 2007;57(5):767-74. PubMed PMID: 17761356.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. 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, Y1 - 2007/08/29/ PY - 2007/01/04/received PY - 2007/04/03/revised PY - 2007/04/10/accepted PY - 2007/9/1/pubmed PY - 2007/11/9/medline PY - 2007/9/1/entrez SP - 767 EP - 74 JF - Journal of the American Academy of Dermatology JO - J. Am. Acad. Dermatol. VL - 57 IS - 5 N2 - 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. SN - 1097-6787 UR - https://www.unboundmedicine.com/medline/citation/17761356/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0190-9622(07)00760-8 DB - PRIME DP - Unbound Medicine ER -