Clinical Study of Probiotic Treatment for Androgenetic Alopecia
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Target Area Hair Counts
研究概览
简要总结
The primary objective of the study is to assess the efficacy of DA-001 as an oral supplement for treatment of female pattern hair loss.
详细描述
DA-001 is a botanical supplement demonstrated natural ingredients known to exert anti-androgen effects. The ingredients were tested in-vitro and have demonstrated the anti-androgen effect. This study aims to compare DA-001 to topical minoxidil in the treatment of female pattern hair loss (also known as androgenetic alopecia).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females Age 18 or older
- •Diagnosed with female pattern hair loss
- •Willing and able to apply the treatment as directed, comply with study
- •Otherwise healthy
- •Able to give informed consent
排除标准
- •A medical history that may interfere with study objectives
- •Women who are pregnant, lactating, or planning to become pregnant during the study period
- •Subjects who have experienced a clinically important medical event within 90 days of the visit (e.g., stroke, myocardial infarction, etc)
- •Subjects who have known allergies to any excipient in DA-001
- •Subjects who are currently participating in another clinical study or have completed another clinical study with an investigational drug or device in the treatment area within 30 days prior to study treatment initiation
- •Subjects who have used any topical prescription medications in the treatment area within 30 days prior to study treatment initiation
- •Subjects who have had a dermatological procedure such as surgery in the treatment area within 30 days prior to study treatment initiation
- •Subject is unable to provide consent or make the allotted clinical visits
研究组 & 干预措施
Topical Minoxidil 5% + Multivitamin Oral Supplement
Topical Minoxidil 5% + Multivitamin Oral Supplement
干预措施: Topical minoxidil 5% (Drug)
Placebo Spray + Daniel Alain Probiotic Treatment for Androgenetic Alopecia
Placebo Spray + Daniel Alain Probiotic Treatment for Androgenetic Alopecia
干预措施: Daniel Alain Probiotic Treatment for Androgenetic Alopecia (Dietary Supplement)
结局指标
主要结局
Target Area Hair Counts
时间窗: Week [0,12]
Target Area Hair Counts
次要结局
未报告次要终点
研究者
Monica Naegle
Study Supervisor
Applied Biology, Inc.