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.
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.


CONCLUSIONS
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.
Olsen
Elise A
EA
Duke University Medical Center, Durham, North Carolina 27516, USA. olsen001@mc.duke.edu
Whiting
David
D
Bergfeld
Wilma
W
Miller
Jeffrey
J
Hordinsky
Maria
M
Wanser
Rita
R
Zhang
Paul
P
Kohut
Bruce
B
D000287:Administration, Topical; D000328:Adult; D000505:Alopecia / Q000188:drug therapy* / Q000473:pathology; D004311:Double-Blind Method; D006197:Hair / Q000473:pathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D008914:Minoxidil / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
D008914:Minoxidil