Clinical Study of DA-002 and DA-005 As a Treatment for Hair Loss
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 516
- 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 safety and efficacy of DA-005 and DA-002 as a treatment for hair loss (androgenetic alopecia).
详细描述
DA-005 is a botanical supplement with demonstrated HIF-1a inhibitory action. The ingredients were tested in-vitro and have demonstrated the HIF-1a inhibitory effect. The primary aim of the study is to compare DA-005 to topical minoxidil in the treatment of hair loss (also known as androgenetic alopecia).
DA-002 is a topical alpha 1 agonist. The ingredients were tested in-vitro and have demonstrated hair growth effects. The secondary aim of the study is to compare DA-002 to topical minoxidil in the treatment of 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
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Diagnosed with androgenetic alopecia
- •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-002 or DA-005
- •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
DA-005
Oral Botanical Supplement HIF-1a inhibitor
干预措施: DA-005 (Dietary Supplement)
DA-005
Oral Botanical Supplement HIF-1a inhibitor
干预措施: Placebo Topical Solution (Other)
Topical Minoxidil 5%
Topical Minoxidil 5%
干预措施: Topical minoxidil 5% (Drug)
Topical Minoxidil 5%
Topical Minoxidil 5%
干预措施: Placebo Oral Tablet (Dietary Supplement)
DA-002
Topical Alpha 1 Agonist
干预措施: DA-002 (Drug)
DA-002
Topical Alpha 1 Agonist
干预措施: Placebo Oral Tablet (Dietary Supplement)
结局指标
主要结局
Target Area Hair Counts
时间窗: Week [0,24]
Target Area Hair Counts
次要结局
未报告次要终点