Efficacy and Safety of 5% Minoxidil Foam in Female Androgenetic Alopecia

Not Applicable

Recruiting

• Conditions: Androgenetic Alopecia
• Interventions: Drug: 5% minoxidil foam; Drug: Placebo for 5% Minoxidil Foam

• Registration Number: NCT07080931
• Lead Sponsor: Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-24
• Status Verified: 2025-07
• Study First Submitted: 2025-07-15
• Study First Submitted QC: 2025-07-15
• Last Update Submitted: 2025-07-15
• Study First Posted: 2025-07-23
• Last Update Posted: 2025-07-23
• Primary Completion: 2027-12
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 294

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

• Study participants with known hypersensitivity to minoxidil or any excipient of the investigational product.
• Study participants with known hair loss disorders other than androgenetic alopecia (AGA)
• Study participants with any scalp disorder at screening that may interfere with efficacy evaluation, as determined by the investigator.
• Lactating women
• Study participants with history of hypotension or uncontrolled hypertension
• Study participants with clinically significant abnormal laboratory findings at screening that may compromise efficacy and safety assessments, as determined by the investigator.
• Study participants with clinically significant ECG abnormalities at screening
• Study participants with history of malignancy prior to screening.
• Study participants known to have conditions or disorders that may affect hair growth or compromise study results.
• Study participants with history of using systemically administered therapeutic drugs prior to screening that may interfere with efficacy evaluation, etc.
• Study participants with history of topical minoxidil application to alopecia-affected areas prior to screening.
• Study participants with no response to prior minoxidil treatment for alopecia
• Study participants with history of 5α-reductase inhibitor use prior to screening.
• Study participants with history of spironolactone or cyproterone treatment prior to screening.
• Study participants with history of autologous platelet-rich plasma (PRP) administration prior to screening.
• Study 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.
• Study participants with history of using medical shampoos or solutions containing ingredients or other components that may interfere with efficacy evaluation prior to screening.
• Study participants planning hair transplantation during the study period, or using hair weaving, non-breathable wigs, or hair bonding during treatment.
• Study participants in other interventional clinical trials within 3 months before screening (excluding non-interventional studies and screen failures) , or planned concurrent clinical trial enrollment.
• Study participants with history of major surgery within 3 months before screening or planning major surgery during the study period.
• Study participants deemed by the investigator to have other conditions that may compromise compliance or render them unsuitable for the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5% Minoxidil Foam	5% minoxidil foam	-
Placebo for 5% Minoxidil Foam	Placebo for 5% Minoxidil Foam	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in Target Area Hair Count (TAHC) at Week 24, assessed via digital phototrichogram analysis in study participa	Week 24

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Beijing, China; 🇨🇳 Beijing, China