Once-daily 5% minoxidil foam for female pattern hair loss

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

This will try once-daily 5% minoxidil foam to see if it increases hair count in adult women with androgenetic alopecia compared with a placebo.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 294 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd. (industry)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Beijing)
• Trial ID: NCT07080931 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional trial compares once-daily 5% minoxidil foam to a matching placebo in adult women diagnosed with androgenetic alopecia. The primary outcome is the Target Area Terminal Hair Count (TAHC) to measure change in hair density. Eligible participants have hair loss graded D3–D6 on the Savin scale and must agree to maintain hairstyle and use effective contraception during the trial. The trial is sponsored by Zhejiang Sunshine Mandi Pharmaceutical and conducted at a site in Beijing, China.

Who should consider this trial

Good fit: Adult women (age ≥18) with investigator-diagnosed androgenetic alopecia graded D3–D6 on the Savin scale who can attend Beijing visits and agree to contraception and stable hair styling.

Not a fit: Women with other hair-loss disorders, known hypersensitivity to minoxidil or product excipients, active scalp conditions that interfere with assessment, lactating women, or those unwilling to use contraception or attend site visits are unlikely to benefit.

Why it matters

Potential benefit: If successful, this could provide a convenient once-daily topical option that increases hair density in women with androgenetic alopecia.

How similar studies have performed: Topical 5% minoxidil has previously shown benefit in increasing hair counts in women, so this foam formulation builds on established evidence.

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:

* 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.

Where this trial is running

Beijing

• Beijing, China — Beijing, China (RECRUITING)

Conditions: Androgenetic Alopecia