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

NCT ID: NCT07080931

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 294 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-24
• Study Completion Date: 2027-12-31

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.

Conditions

Androgenetic Alopecia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

5% Minoxidil Foam

Group Type: EXPERIMENTAL

5% minoxidil foam

Intervention Type: DRUG

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

Group Type: PLACEBO_COMPARATOR

Placebo for 5% Minoxidil Foam

Intervention Type: DRUG

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.

Interventions

5% minoxidil foam

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.

Intervention Type: DRUG

Placebo for 5% Minoxidil Foam

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing, China

Beijing, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Linyu Zhu

Role: primary

zhulinyu@wsh.3sbio.com

18013840514

Other Identifiers

P-M2405(Foam)-lc

Identifier Type: -

Identifier Source: org_study_id