A Randomized, Double-Blind, Vehicle-Controlled, Sample Size Adaptive Design Study to Evaluate the Safety and Efficacy of Topically Applied EB01 Cream in Healthy Adult Volunteers and Adult Subjects with Moderate to Severe Chronic Allergic Contact Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 15
- 主要终点
- Mean percent change from baseline in the Contact Dermatitis Severity Index (CDSI)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of EB01 Cream (0.2%, 1.0%, 2.0%) applied twice per day (BID) for the treatment of moderate to severe chronic allergic contact dermatitis (ACD).
The purpose of the open label extension is to assess the long-term safety, tolerability, and efficacy of EB01 2.0% cream in subjects with moderate to severe chronic allergic contact 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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
EB01 Cream Placebo
EB01 Cream containing 0% EB01 w/w applied BID
干预措施: EB01 Cream Placebo (Drug)
EB01 Cream 0.2%
EB01 Cream containing 0.2% EB01 w/w applied BID
干预措施: EB01 Cream 0.2% (Drug)
EB01 Cream 1.0%
EB01 Cream containing 1.0% EB01 w/w applied BID
干预措施: EB01 Cream 1.0% (Drug)
EB01 Cream 2.0%
EB01 Cream containing 2.0% EB01 w/w applied BID
干预措施: EB01 Cream 2.0% (Drug)
结局指标
主要结局
Mean percent change from baseline in the Contact Dermatitis Severity Index (CDSI)
时间窗: Day 29
次要结局
- Mean percent change from baseline in CDSI(Days 15, 59, 89, and 119)
- Proportion of subjects achieving at least a 2-grade reduction from baseline to clear (0) or almost clear (1) in Investigator's Static Global Assessment (ISGA)(Days 15, 29, 59, 89, and 119)
- Mean percent change from baseline in Body Surface Area (BSA) affected with chronic allergic contact dermatitis(Days 15, 29, 59, 89, and 119)
- Change from baseline in Dermatology Life Quality Index (DLQI)(Days 15, 29, 59, 89, and 119)
- Proportion of patients achieving at least a 2-point reduction from peak pruritis Numerical Rating Scale (NRS) score from Baseline(Days 15, 29, 59, 89, and 119)
- Proportion of patients achieving at least a 4-point reduction from peak pruritis Numerical Rating Scale (NRS) score from Baseline(Days 15, 29, 59, 89, and 119)