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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5% Minoxidil Foam | Experimental |
| |
| Placebo for 5% Minoxidil Foam | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5% minoxidil foam | Drug | Trial 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Target Area Hair Count (TAHC) at Week 24, assessed via digital phototrichogram analysis in trial participa | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in Target Area Hair Count (TAHC) at Weeks 6, 12, and 18 | Weeks 6, 12, and 18 | |
| Percent change from baseline in Target Area Hair Count (TAHC) at Weeks 12 and 24 | Weeks 12 , 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing, China | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Placebo for 5% Minoxidil Foam | Drug | Trial 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. |
|
| Self-assessed satisfaction scores at Weeks 6, 12, 18, and 24 | Weeks 6, 12, 18, 24 |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |