Androgenetic Alopecia Clinical Trial
Official title:
A Double-Blind, Randomized, Placebo-Controlled Trial of the Efficacy and Safety of 5 Percent Minoxidil Foam in the Treatment of Androgenetic Alopecia in Males
The primary purpose of the study is to evaluate the efficacy of a topical 5% minoxidil formulation in males for the treatment of pattern hair loss. The secondary purpose is to evaluate the safety of a topical 5% minoxidil formulation in males when used twice daily for the treatment of pattern hair loss and to obtain the safety data on the investigational product when used twice daily for up to one year.
Male subjects with androgenetic alopecia were enrolled in this fourteen-center trial.
Subjects were randomized to use either 5% minoxidil or placebo foam twice daily for 16
weeks. A total of 143 subjects continued use of the 5% minoxidil foam for 8 to 12 months in
an open-label phase to obtain safety data on 5% minoxidil topical foam when used twice daily
for up to one year.
The 5% minoxidil foam was shown to be effective in the treatment of male androgenetic
alopecia in a 16 week trial. It was statistically significantly superior to placebo foam in
the primary efficacy measure of mean change in the non-vellus hair count in the target
region between Baseline and Week 16, and the subject rating assessed an overall improvement
from Baseline.
The efficacy of 5% minoxidil compared to placebo was confirmed by the secondary efficacy
endpoints of scores from the expert panel review of hair regrowth when comparing photographs
obtained at Baseline with photographs obtained at Week 16, as well as the percent change
from Baseline in non-vellus hair counts within a pre-specified area of clipped hair.
The 5% minoxidil foam formulation was well tolerated, the incidence of adverse events was
similar between groups, and no safety concerns were raised based on clinical laboratory test
results, vital signs or scalp irritation scores.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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