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

NCT07080931 | Recruiting Phase 3

• 1 other identifier: P-M2405(Foam)-lc
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

Brief Summary

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

Androgenetic Alopecia

Keywords

Androgenetic Alopecia

Outcome Measures

Primary Outcomes (1)

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

  Week 24

Secondary Outcomes (3)

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

  Weeks 6, 12, and 18

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

  Weeks 12 , 24

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

  Weeks 6, 12, 18, 24

Study Arms (2)

5% Minoxidil Foam

EXPERIMENTAL

Drug: 5% minoxidil foam

Placebo for 5% Minoxidil Foam

PLACEBO COMPARATOR

Drug: Placebo for 5% Minoxidil Foam

Interventions

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.

5% Minoxidil Foam

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.

Placebo for 5% Minoxidil Foam

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.: lead

Study Sites (1)

Beijing, China

Beijing, China

RECRUITING

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: July 23, 2025
• Study Start: February 24, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

CN (1)