Efficacy and Safety of 5% Minoxidil Foam in Female Androgenetic Alopecia (NCT07080931) | Clinical Trial Compass
RecruitingPhase 3
Efficacy and Safety of 5% Minoxidil Foam in Female Androgenetic Alopecia
China294 participantsStarted 2025-02-24
Plain-language summary
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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* 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;
* Willingness to maintain identical hairstyle, hair color, and hair length at each follow-up visit;
* No pregnancy plans during the study and for 3 months post-last dose, with commitment to highly effective contraception. Women of childbearing potential must have negative serum pregnancy test ≤7 days prior to first investigational product administration
Exclusion Criteria:
* 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 participants with history of hypotension or uncontrolled hypertension
* Trial participants with clinically significant abnormal laboratory findings at screening that may compromise efficacy and safety assessments, as determined by the investigator.
* Trial participants with clinically significant ECG abnormalities at screening
* Trial participants with history of malignancy prior to screening.
* Trial participants known to have conditions or disorders that may affect hair growth or compromise study…
What they're measuring
1
Change from baseline in Target Area Hair Count (TAHC) at Week 24, assessed via digital phototrichogram analysis in trial participa