About this trial
The primary objective of this study is to evaluate the efficacy of once-daily 5% minoxidil foam versus placebo in female androgenetic alopecia, using the Target Area Terminal Hair Count (TAHC) as the primary endpoint.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntarily participate in the study and be able to provide a written Informed Consent Form (ICF);
Female aged ≥ 18 years;
Investigator-diagnosed androgenetic alopecia;
Hair loss severity graded D3 to D6 on the Savin scale;
Disqualifiers
Trial participants with known hypersensitivity to minoxidil or any excipient of the investigational product.
Trial participants with known hair loss disorders other than androgenetic alopecia (AGA)
Trial participants with any scalp disorder at screening that may interfere with efficacy evaluation, as determined by the investigator.
Lactating women
Trial design
Parallel
Treatments tested in this trial
5% minoxidil foam
DrugTrial participants applied 5% minoxidil foam topically once daily (QD) in the morning or evening, with a maximum daily dose not exceeding 1 g, for up to 24 weeks.
Placebo for 5% Minoxidil Foam
DrugTrial participants applied placebo once daily (QD) in the morning or evening, with a maximum daily dose not exceeding 1 g, for up to 24 weeks.
Treatment groups
Trial outcomes
Primary outcomes
Change from baseline in Target Area Hair Count (TAHC) at Week 24, assessed via digital phototrichogram analysis in trial participa
Secondary outcomes
Mean change from baseline in Target Area Hair Count (TAHC) at Weeks 6, 12, and 18
Percent change from baseline in Target Area Hair Count (TAHC) at Weeks 12 and 24
Self-assessed satisfaction scores at Weeks 6, 12, 18, and 24
Sponsors and contacts
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