A Phase 2 Double-blind, Multicentre, Placebo Controlled, Parallel Group Design to Assess the Efficacy, Safety and Dose Response Characterisation of STS01 for the Treatment of Mild-moderate Alopecia Areata (AA)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 158
- 试验地点
- 9
- 主要终点
- Relative change from baseline in Alopecia areata severity measured using the Severity of Alopecia Tool (SALT) at 6 months
研究概览
简要总结
A Phase 2 double-blind, multi-site, placebo-controlled, parallel-group design to assess the efficacy, safety and dose-response characterisation of STS-01 for the treatment of mild- moderate alopecia areata.
详细描述
STS-01 is being developed to address the need for an effective, safe and convenient non-steroidal topical treatment for mild-moderate alopecia areata. The product builds on a mechanism with a well-established safety profile in dermatology, and existing evidence of its effectiveness in this condition through targeting key relevant cytokines. STS-01 has been modified to maximise the effectiveness of this mechanism and offer a cosmetically elegant topical cream. The study aims to assess the effectiveness, safety and dose-response characteristics of STS-01 for the treatment of mild-moderate alopecia areata.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active alopecia areata (less than 50% SALT score, present for at least 6 months)
- •Not currently receiving treatment for hair loss
- •Eighteen years of age or more
- •Affected skin with normal appearance and no grossly evident epidermal alteration such as scaling or follicular abnormalities
排除标准
- 未提供
研究组 & 干预措施
0.25% Dose
Once daily, STS-01 topical cream applied to affected area of the head
干预措施: STS01 (Drug)
0.5% Dose
Once daily, STS-01 topical cream applied to affected area of the head
干预措施: STS01 (Drug)
1% Dose
Once daily, STS-01 topical cream applied to affected area of the head
干预措施: STS01 (Drug)
2% Dose
Once daily, STS-01 topical cream applied to affected area of the head
干预措施: STS01 (Drug)
Placebo
Once daily, topical cream applied to affected area of the head (without API)
干预措施: Placebo (Drug)
结局指标
主要结局
Relative change from baseline in Alopecia areata severity measured using the Severity of Alopecia Tool (SALT) at 6 months
时间窗: 6 Months
Alopecia areata severity measured using the Severity of Alopecia Tool (SALT) at 6 months. Targeting patients with \<50 SALT (less than 50% hair loss).
次要结局
- Global assessment using the Clinical Global Impression (CGI) score(6 Months)
- Regrowth area measured by graphical measuring of the size of the patch(6 months)
- AA quality of life measured using Subject Alopecia Areata Symptom Impact Scale (AASIS)(6 Months)
- AA quality of life measured using Alopecia Areata Quality of Life Index (AAQLI) 0-25(6 months)