4-Week Multicenter, Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Safety and Efficacy Study of PUR 0110 (Thykamine™) Cream Applied Twice Daily in Mild-to-Moderate Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 12
- 主要终点
- Efficacy as per investigator global assessment (IGA)
研究概览
简要总结
A Phase 2, multicenter, double-blind, placebo control study evaluating the safety and efficacy of Thykamine in adult patient suffering of mild-to-moderate Atopic Dermatitis
详细描述
4-week Multicenter, Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Safety and Efficacy Study of Three Concentrations (0.05%, 0.1% and 0.25%) of PUR 0110 (Thykamine™) Cream Applied Twice Daily in Mild-to-Moderate Atopic Dermatitis.
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)
盲法说明
Treatment were packaged in identical jars. Eligible patients will be randomized in a 1:1:1:1 ratio to receive either one of 3 concentrations of PUR 0110 cream (0.05%, 0.1% and 0.25%) or vehicle (placebo).
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
PUR0110 (Thykamine) 0.05%
Administration of PUR0110 (Thykamine) 0.05%
干预措施: Administration of PUR0110 (Thykamine) 0.05% (Drug)
Placebo
Administration of Placebo
干预措施: Administration of Placebo (Drug)
PUR0110 (Thykamine) 0.10%
Administration of PUR0110 (Thykamine) 0.10%
干预措施: Administration of PUR0110 (Thykamine) 0.1% (Drug)
PUR0110 (Thykamine) 0.25%
Administration of PUR0110 (Thykamine) 0.25%
干预措施: Administration of PUR0110 (Thykamine) 0.25% (Drug)
结局指标
主要结局
Efficacy as per investigator global assessment (IGA)
时间窗: Baseline and 4 weeks
Efficacy as per investigator global assessment (IGA) of clear (0), almost clear (1) at Day 29 and with a decrease from baseline in IGA of at least 2 grades at Day 29.
次要结局
- Incidence and severity of adverse events (AEs) (systemic and local)(Baseline and 4 weeks)
- Change in pruritus(Baseline and 4 weeks)
- Change from baseline in Atopic Dermatitis (AD) score(Baseline and 4 weeks)
- Proportion of patients with change in Investigator Global Assessment (IGA)(Baseline and 3 weeks)
- Change in Eczema Area and Severity Index (EASI)(Baseline and 4 weeks)