Actively Recruiting

Phase 3
Age: 18Years +
FEMALE
NCT07080931

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

Led by Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd. · Updated on 2026-03-05

294

Participants Needed

1

Research Sites

144 weeks

Total Duration

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AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Willing to participate and able to provide written informed consent
  • Female aged 18 years or older
  • Diagnosed with androgenetic alopecia by an investigator
  • Hair loss severity graded between D3 and D6 on the Savin scale
  • Willing to keep the same hairstyle, hair color, and hair length during follow-up visits
  • No pregnancy plans during the study and for 3 months after last dose, with commitment to effective contraception
  • Negative serum pregnancy test within 7 days before first treatment
Not Eligible

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 that may affect treatment assessment
  • Currently breastfeeding
  • History of low or uncontrolled high blood pressure
  • Significant abnormal lab or ECG results at screening
  • History of cancer before screening
  • Conditions affecting hair growth or study results
  • Recent use of systemic drugs interfering with treatment evaluation
  • Previous use of topical minoxidil on affected areas
  • No response to prior minoxidil treatment
  • Previous use of 5α-reductase inhibitors, spironolactone, or cyproterone
  • Previous autologous platelet-rich plasma treatments
  • History of chemotherapy, scalp radiation, low-level laser therapy, or scalp surgery for hair loss
  • Use of medical shampoos or solutions that may affect treatment assessment
  • Plans for hair transplantation or use of hair weaving, non-breathable wigs, or hair bonding during study
  • Participation in other interventional clinical trials within 3 months before screening or planned concurrent enrollment
  • 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

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Trial Site Locations

Total: 1 location

1

Beijing, China

Beijing, China

Actively Recruiting

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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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