Clinical Study of DA-001 as a Treatment for Hair Shedding Reduction and Hair Re-Growth
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 1,120
- 主要终点
- Mean Change in Hair Shedding
研究概览
简要总结
The primary objective of the study is to assess the safety and efficacy of DA-001 as a treatment for Hair Shedding Reduction and Hair Re-Growth
详细描述
DA-001 is a topical alpha 1 agonist combined with a TAAR receptor agonist. DA-001 was studied in a population of women that suffer from excessive hair shedding. DA-001 demonstrated significant reduction in hair shedding.
This study aims to assess the safety and efficacy of DA-001 as a treatment for Hair Shedding Reduction and Hair Re-Growth.
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 telogen effluvium
- •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
Placebo
Placebo
干预措施: Placebo (Other)
DA-001 Topical + DA-005 Oral (HIF-1α supplement)
DA-001 Topical (Phenylephrine 2.5% Topical + TAAR agonist tyramine) + DA-005 Oral (HIF-1α supplement)
干预措施: DA-001 Topical + DA-005 Oral (HIF-1α supplement) (Other)
DA-010 - Oral Phenylephrine 20 mg + DA-005 Oral (HIF-1α supplement)
Oral Phenylephrine 20 mg + DA-005 Oral (HIF-1α supplement)
干预措施: DA-010 - Oral Phenylephrine 20 mg + DA-005 Oral (HIF-1α supplement) (Other)
Phenylephrine Topical 0.25% + Intact Pro Topical
Phenylephrine Topical 0.25% + Intact Pro Topical
干预措施: Phenylephrine Topical 0.25% + Intact Pro Topical (Drug)
Phenylephrine + Intact Pro + DA-005 Oral (HIF-1α supplement)
Phenylephrine + Intact Pro + DA-005 Oral (HIF-1α supplement)
干预措施: Phenylephrine + Intact Pro + DA-005 Oral (HIF-1α supplement) (Other)
DA-001 Topical
Phenylephrine 2.5% Topical + TAAR agonist
干预措施: DA-001 (Drug)
Phenylephrine Topical
Phenylephrine 2.5% Topical (per application volume - males 5mL and females 20mL)
干预措施: Phenylephrine (Drug)
结局指标
主要结局
Mean Change in Hair Shedding
时间窗: Minutes [0,5]
Number of hairs shedding during brushing at target area
次要结局
- Mean Change in Hair Shedding(Week [0, 4, 12, 24])
- Mean Change in Target Area Hair Count (TAHC)(Week [0, 4, 12, 24])