Actively Recruiting
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
Led by Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd. · Updated on 2026-03-05
294
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of a once-daily 5% minoxidil foam compared to a placebo in women with androgenetic alopecia. This study aims to measure hair growth improvements using the Target Area Terminal Hair Count (TAHC) as the main endpoint. It is a Phase 3, randomized, double-blind, placebo-controlled trial sponsored by Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd. Participants will apply either 5% minoxidil foam or a placebo foam once daily, in the morning or evening, with a maximum dose of 1 gram per day for up to 24 weeks. The study involves two groups: one receiving the active foam and the other receiving placebo. Treatment adherence and effects will be monitored throughout the 24-week period. During the study, participants will undergo digital phototrichogram analysis at weeks 6, 12, 18, and 24 to measure changes in hair count. They will also self-assess their satisfaction at these times. Safety and efficacy will be evaluated through these measures, with the main outcome assessed at week 24. The total participation duration is approximately 24 weeks.
CONDITIONS
Brief Title
Efficacy and Safety of 5% Minoxidil Foam in Female Androgenetic Alopecia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and provide written informed consent
- Female aged 18 years or older
- Diagnosed by an investigator with androgenetic alopecia
- Hair loss severity graded D3 to D6 on the Savin scale
- Willing to keep the same hairstyle, hair color, and hair length at each visit
- No pregnancy plans during the study and 3 months after last dose, with commitment to effective contraception
- Negative serum pregnancy test within 7 days before first study treatment
You will not qualify if you...
- Known allergy to minoxidil or any ingredient in the study product
- Hair loss disorders other than androgenetic alopecia
- Scalp conditions interfering with effectiveness evaluation
- Currently breastfeeding
- History of low or uncontrolled high blood pressure
- Significant abnormal lab results or ECG issues at screening
- History of cancer before screening
- Conditions that affect hair growth or study results
- Prior use of systemic drugs affecting hair growth before screening
- Previous use of topical minoxidil on affected areas
- No response to earlier minoxidil treatment for hair loss
- History of 5α-reductase inhibitor, spironolactone, or cyproterone use
- Previous autologous platelet-rich plasma treatments
- Past chemotherapy, scalp radiation, laser therapy, or scalp surgery for hair loss
- Use of medical shampoos or solutions interfering with study
- Plans for hair transplantation or use of hair weaving, non-breathable wigs, or hair bonding during study
- Participation in other interventional trials within 3 months before screening or planned concurrent trials
- Major surgery within 3 months before screening or planned during study
- Other conditions judged by the investigator to affect compliance or suitability
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks
Participants apply 5% minoxidil foam or placebo topically once daily for up to 24 weeks.
Visits at Weeks 6, 12, 18, and 24 for assessments
Trial Site Locations
Total: 1 location
1
Beijing, China
Beijing, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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