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

Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.

Status and phase

Enrolling

Phase 3

Conditions

Androgenetic Alopecia

Treatments

Drug: Placebo for 5% Minoxidil Foam

Drug: 5% minoxidil foam

Study type

Interventional

Funder types

Industry

Identifiers

NCT07080931

P-M2405(Foam)-lc

Details and patient eligibility

About

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.

Enrollment

294 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.