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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 5% minoxidil foam
  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.
• Препарат Placebo for 5% Minoxidil Foam
  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.

Первичные конечные точки

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

Вторичные конечные точки (3)

• Mean change from baseline in Target Area Hair Count (TAHC) at Weeks 6, 12, and 18 [Срок оценки: Weeks 6, 12, and 18]
• Percent change from baseline in Target Area Hair Count (TAHC) at Weeks 12 and 24 [Срок оценки: Weeks 12 , 24]
• Self-assessed satisfaction scores at Weeks 6, 12, 18, and 24 [Срок оценки: Weeks 6, 12, 18, 24]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing, China — Пекин

Идентификаторы

NCT: NCT07080931 · P-M2405(Foam)-lc

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗