NCT05579899已完成2 期
A Randomized, Vehicle-controlled, Safety and Efficacy Study of EVO101 in Adult Subjects With Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 21
- 主要终点
- Percent Change in Eczema Area and Severity Index (EASI) From Baseline to Week 8
研究概览
简要总结
This is a Phase 2a safety and efficacy study of EVO101 for the treatment of adults with atopic dermatitis
详细描述
This is a Phase 2a safety and efficacy study of EVO101 Topical Cream, 0.1%, applied twice daily for 8 weeks in adults with 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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Matching vehicle
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
- •Males or non-pregnant, non-lactating females, age 18 years or older
- •Chronic atopic dermatitis for at least 1 year
- •IGA score of 2 or 3
- •BSA of AD involvement of 4-12%
- •EASI of 5-20
排除标准
- •Significant AD flare with 4 weeks
- •Use of biologic therapy within 12 weeks
- •Regular use of tanning booth within 4 weeks
- •Skin condition that could interfere with study assessments
研究组 & 干预措施
EVO101 Cream
Experimental
Active Treatment, BID, 8 weeks
干预措施: EVO101 (Drug)
Vehicle Cream
Placebo Comparator
Vehicle Treatment, BID, 8 weeks
干预措施: EVO101 (Drug)
结局指标
主要结局
Percent Change in Eczema Area and Severity Index (EASI) From Baseline to Week 8
时间窗: 8 weeks
EASI assesses the extent and severity of atopic dermatitis. EASI is a composite index with scores ranging from 0 to 72. Higher values indicate more severe or extensive disease.
次要结局
- Investigator Global Assessment (IGA) Response (Number of Participants With >= 2 Points Change From Baseline to Week 8)(8 weeks)
- Percent Body Surface Area (BSA) Affected by Atopic Dermatitis Over Time, Change From Baseline to Week 8(8 weeks)
- Pruritus-NRS, Change From Baseline to Week 8(8 weeks)
研究者
研究点 (21)
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