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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorZhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.

About this trial

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 criteria

Qualifiers

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;

Disqualifiers

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 design

Treatments tested in this trial

  • 5% minoxidil foam
  • Placebo for 5% Minoxidil Foam

Treatment groups

294 Participants
are divided into 2 treatment groups