Androgenetic AlopeciaPhase 3NCT07080931
Efficacy and Safety of 5% Minoxidil Foam in Female Androgenetic Alopecia
A Phase 3 study testing 5% minoxidil foam in people with Androgenetic Alopecia, run by Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- 5% minoxidil foam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 294 participants
- Where
- 1 siteChina
- Study dates
- 24 Feb 2025to Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 21Show fewer
- 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.
- Trial participants with history of chemotherapy, cytotoxic agents, scalp radiation, and/or low-level laser therapy (LLLT) or surgical scalp procedures for FAGA prior to screening.
- Trial participants with history of using medical shampoos or solutions containing ingredients or other components that may interfere with efficacy evaluation prior to screening.
- Trial participants planning hair transplantation during the study period, or using hair weaving, non-breathable wigs, or hair bonding during treatment.
- Trial participants in other interventional clinical trials within 3 months before screening (excluding non-interventional studies and screen failures) , or planned concurrent clinical trial enrollment.
- Trial participants with history of major surgery within 3 months before screening or planning major surgery during the study period.
- Trial participants deemed by the investigator to have other conditions that may compromise compliance or render them unsuitable for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing, China
Beijing
Linyu Zhu, 18013840514, zhulinyu@wsh.3sbio.com
About this study
Official title: 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
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
- Being tested
- 5% minoxidil foam, Placebo for 5% Minoxidil Foam
- Keywords
- Androgenetic Alopecia
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% minoxidil foamDrug
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 FoamDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 5% Minoxidil Foam | Experimental | Not described Receives: Drug: 5% minoxidil foam |
| Placebo for 5% Minoxidil Foam | Placebo comparator | Not described Receives: Drug: Placebo for 5% Minoxidil Foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Target Area Hair Count (TAHC) at Week 24, assessed via digital phototrichogram analysis in trial participa
Measured: Week 24
Secondary outcomes (3)
Mean change from baseline in Target Area Hair Count (TAHC) at Weeks 6, 12, and 18
Measured: Weeks 6, 12, and 18
Percent change from baseline in Target Area Hair Count (TAHC) at Weeks 12 and 24
Measured: Weeks 12 , 24
Self-assessed satisfaction scores at Weeks 6, 12, 18, and 24
Measured: Weeks 6, 12, 18, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start24 Feb 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 294 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080931
- Sponsor's protocol ID
- P-M2405(Foam)-lc
- Status last verified
- Mar 2026
- First submitted
- 15 Jul 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07080931
- Acronym / sponsor ID
- P-M2405(Foam)-lc
- Conditions
- Androgenetic Alopecia
- Keywords
- Androgenetic Alopecia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5% Minoxidil Foam | Experimental | Drug: 5% minoxidil foam |
| Placebo for 5% Minoxidil Foam | Placebo comparator | Drug: Placebo for 5% Minoxidil Foam |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5% minoxidil foamTrial 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. | Drug | 5% Minoxidil Foam |
| Placebo for 5% Minoxidil FoamTrial 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. | Drug | Placebo for 5% Minoxidil Foam |
Primary outcome
Change from baseline in Target Area Hair Count (TAHC) at Week 24, assessed via digital phototrichogram analysis in trial participa
Time frame: Week 24
3 secondary outcomes
Mean change from baseline in Target Area Hair Count (TAHC) at Weeks 6, 12, and 18
Time frame: Weeks 6, 12, and 18
Percent change from baseline in Target Area Hair Count (TAHC) at Weeks 12 and 24
Time frame: Weeks 12 , 24
Self-assessed satisfaction scores at Weeks 6, 12, 18, and 24
Time frame: Weeks 6, 12, 18, 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 5% minoxidil foam in people with Androgenetic Alopecia, run by Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Target Area Hair Count (TAHC) at Week 24, assessed via digital phototrichogram analysis in trial participa (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.