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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 5% minoxidil foam

    Drug

    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.

  • Placebo for 5% Minoxidil Foam

    Drug

    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.

Treatment groups

294 Participants
are divided into 2 treatment groups
Group A: 5% Minoxidil FoamExperimental treatment 1 intervention
Group B: Placebo for 5% Minoxidil FoamPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in Target Area Hair Count (TAHC) at Week 24, assessed via digital phototrichogram analysis in trial participa

Time frame
Week 24

Secondary outcomes

1

Mean change from baseline in Target Area Hair Count (TAHC) at Weeks 6, 12, and 18

Time frame
Weeks 6, 12, and 18
2

Percent change from baseline in Target Area Hair Count (TAHC) at Weeks 12 and 24

Time frame
Weeks 12 , 24
3

Self-assessed satisfaction scores at Weeks 6, 12, 18, and 24

Time frame
Weeks 6, 12, 18, 24

Other outcomes

Sponsors and contacts

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