NCT01784133已完成2 期
A Phase 2, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Three Once-Daily CLS001 Topical Gels Versus Vehicle Administered for 12 Weeks to Subjects With Papulopustular Rosacea
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
- 240
- 试验地点
- 17
- 主要终点
- Change in inflammatory lesion count
研究概览
简要总结
The purpose of this study is to evaluate th safety and efficacy of one-daily topical application of CLS001 low, mid and high dose compared to vehicle gel in subjects with papulopustular rosacea.
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)
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
- •diagnosis of papulopustular rosacea (at least 15 lesions)
排除标准
- •nodular rosacea or subtype 3
- •clinically significant abnormal findings that would interfere with study objectives
研究组 & 干预措施
omiganan mid dose
Active Comparator
omiganan mid dose once daily application for 12 weeks
干预措施: omiganan (Drug)
omiganan high dose
Active Comparator
omiganan high dose once daily application for 12 weeks
干预措施: omiganan (Drug)
Vehicle group
Placebo Comparator
Vehicle once daily application for 12 weeks
干预措施: placebo (Drug)
omiganan low dose
Active Comparator
omiganan low dose once daily application for 12 weeks
干预措施: omiganan (Drug)
结局指标
主要结局
Change in inflammatory lesion count
时间窗: 0, 1, 3, 6, 9 and 12 weeks
次要结局
- Success on IGA defined as clear or almost clear(Week 12)
研究者
研究点 (17)
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