NCT06745336尚未招募3 期
Clinical Study of CS-001 As a Treatment for Canities (Grey Hair)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 240
- 主要终点
- Greying Severity Score
研究概览
简要总结
Clinical Study to Assess the Safety and Efficacy of CS-001 as a treatment for Canities (Grey Hair)
详细描述
CS-001 is a small molecule that affects lysosomal storage and transfer of melanin from hair follicle melanocytes. In vitro and a small pilot study demonstrated re-pigmentation of grey hair following CS-001 application. The aim of this study is to assess the safety and efficacy of CS-001 as a treatment for grey hair.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30 to 65
- •Diagnosed with Grey Hair (Canities)
- •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 CS-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
CS-001
Experimental
CS-001 Topical Treatment
干预措施: CS-001 (Drug)
Placebo
Placebo Comparator
Placebo Topical Treatment
干预措施: Placebo Topical Solution (Drug)
结局指标
主要结局
Greying Severity Score
时间窗: Week [0,52]
Greying Severity Score (GSS). Mild Greying score between 0-5, Moderate Greying score between 6-10 and Severe Greying score between 11-15
次要结局
未报告次要终点
研究者
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