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Tests treatment safety and results for Androgenetic Alopecia
Official title Efficacy and Safety of 5% Minoxidil Foam in Female Androgenetic Alopecia
ClinicalTrials.gov ID: NCT07080931
What this study is testing
What is 5% minoxidil foam?
5% minoxidil foam is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for androgenetic alopecia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join 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;
You likely can't join 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 how well it works 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 how well it works and safety...
See the full eligibility 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...
- 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 how well it works 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 how well it works 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 how well it works 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 how well it works 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 treatment clinical trials within 3 months before screening (excluding non-treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.