Androgenetic Alopecia
Conditions
Keywords
Androgenetic Alopecia
Brief 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.
Interventions
DRUG5% minoxidil foam
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.
DRUGPlacebo for 5% Minoxidil Foam
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.
Sponsors
Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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 results. * Trial participants with history of using systemically administered therapeutic drugs prior to screening that may interfere with efficacy evaluation, etc. * Trial participants with history of topical minoxidil application to alopecia-affected areas prior to screening. * Trial participants with no response to prior minoxidil treatment for alopecia * Trial participants with history of 5α-reductase inhibitor use prior to screening. * Trial participants with history of spironolactone or cyproterone treatment prior to screening. * Trial participants with history of autologous platelet-rich plasma (PRP) administration prior to screening. * Trial participants with history of chemotherapy, cytotoxic agents, scalp radiation, and/or low-level laser therapy (LLLT) or surgical scalp procedures for FAGA prior to screening. * Trial participants with history of using medical shampoos or solutions containing ingredients or other components that may interfere with efficacy evaluation prior to screening. * Trial participants planning hair transplantation during the study period, or using hair weaving, non-breathable wigs, or hair bonding during treatment. * Trial participants in other interventional clinical trials within 3 months before screening (excluding non-interventional studies and screen failures) , or planned concurrent clinical trial enrollment. * Trial participants with history of major surgery within 3 months before screening or planning major surgery during the study period. * Trial participants deemed by the investigator to have other conditions that may compromise compliance or render them unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Target Area Hair Count (TAHC) at Week 24, assessed via digital phototrichogram analysis in trial participa | Week 24 |
Secondary
| Measure | 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 |
| Self-assessed satisfaction scores at Weeks 6, 12, 18, and 24 | Weeks 6, 12, 18, 24 |
Countries
China
Outcome results
None listed