RecruitingPhase 3NCT07080931

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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study on the Efficacy and Safety of 5% Minoxidil Foam in the Treatment of Female Androgenetic Alopecia

Sponsor

Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.

Enrollment

294 participants

Start Date

Feb 24, 2025

Study Type

INTERVENTIONAL

Conditions

androgenetic alopecia

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria6

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 Criteria21

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.

Interested in this trial?

Get notified about updates and connect with the research team.

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.