NCT02571998已完成2 期
A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Multicenter Study to Evaluate the Safety and Efficacy of CLS001 Topical Gel Versus Vehicle Applied Once Daily for 12 Weeks to Female Subjects With Moderate to Severe Acne Vulgaris
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
- 320
- 主要终点
- Absolute change from baseline in inflammatory lesion counts at week 12
研究概览
简要总结
The primary objective of this study is to evaluate the safety and efficacy of Omiganan (CLS001) topical gel compared to vehicle topical gel applied once daily for 12 weeks in female subjects with moderate to severe inflammatory acne vulgaris.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Non-pregnant female subjects ≥ 12 years of age with facial acne vulgaris
- •Subjects with an Investigator's Global Assessment (IGA) of Inflammatory Lesions of Acne Vulgaris of Moderate (3) or Severe (4) at Baseline.
- •Subjects with ≥ 30 facial inflammatory lesions
排除标准
- •Subjects with < 10 or > 75 facial non-inflammatory lesions
- •Subjects with > 3 facial nodular or cystic lesions at Baseline
- •Standard exclusion criteria
研究组 & 干预措施
Treatment
Experimental
Omiganan (CLS001) Topical Gel applied once daily
干预措施: Omiganan (CLS001) Topical Gel (Drug)
Vehicle Gel
Placebo Comparator
Vehicle Topical Gel applied once daily
干预措施: Vehicle Topical Gel (Drug)
结局指标
主要结局
Absolute change from baseline in inflammatory lesion counts at week 12
时间窗: 12 weeks
次要结局
- Percentage of subjects with an IGA of Inflammatory Lesions of Acne Vulgaris of clear or almost clear (0 or 1) at each visit(12 weeks)
- Percentage of subjects with an IGA of Inflammatory Lesions of Acne Vulgaris of clear or almost clear (0 or 1) and at least a two grade reduction in the IGA of Inflammatory Lesions of Acne Vulgaris at each visit.(12 weeks)
- Absolute change from Baseline at each visit in inflammatory lesions, non-inflammatory lesions, and total lesions(12 weeks)
- Percentage of subjects with at least a two grade reduction in the IGA of Inflammatory Lesions of Acne Vulgaris at each visit(12 weeks)
研究者
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