CTRI/2025/04/084270招募中1 期
A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Topically Applied SCD-153 in Patients With Alopecia Areata
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 18
- 主要终点
- Incidence of unacceptable toxicity
研究概览
简要总结
This is a phase 1b, multicenter, randomized, double-blind, vehicle-controlled study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of topically applied SCD-153 in patients with alopecia areata. The subjects will be evaluated in four sequential dose levels (strength 1, strength 2, strength 3 and strength 4) based on the safety data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult males between 18-55 years (both inclusive) and adult non-pregnant, non-lactating females between 18-45 years of age (both inclusive) at Screening.
- •Clinical diagnosis of Alopecia Areata.
- •Willingness to provide written informed consent and comply with the protocol requirements.
排除标准
- •History or presence of clinically relevant, systemic disease.
- •Laboratory abnormalities at Screening that is assessed as clinically significant by the investigator.
- •History of allergy to investigational medicinal product or excipients and any history of and/or concurrent condition of serious hypersensitivity (e.g., anaphylaxis) to drugs, foods, or other allergens.
- •Participation in an investigational drug study in which the administration of the investigational drug was within 30 days.
- •Active inflammatory skin disease other than AA or active trauma on the scalp that could potentially interfere with assessments.
- •History or presence of hair transplants.
结局指标
主要结局
Incidence of unacceptable toxicity
时间窗: Week 29
次要结局
- Incidence and severity of adverse events(Week 29)
- Incidence of local skin reactions(Week 29)
研究者
Dr Mudgal Kothekar
Sun Pharma Advanced Research Limited
研究点 (18)
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