Efficacy and Safety of 5% Minoxidil Foam in Female Androgenetic Alopecia
Recruiting
Phase 3Interventional Study
Androgenetic Alopecia
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
294 (estimated)
Sponsor
Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd. · Industry
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
* 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, …
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
* 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.
Contacts
No contact information available.
What are you hoping to find?
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.