NCT02576860已完成3 期
A Phase 3, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Once-Daily CLS001 Topical Gel Versus Vehicle Administered for 12 Weeks to Subjects With Papulopustular Rosacea With a 4 Week Follow-up Period
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 263
- 主要终点
- Efficacy Absolute Change in Inflammatory Lesion Count
研究概览
简要总结
This study evaluates the safety and efficacy of once-daily application of CLS001 topical gel compared to vehicle gel in subjects with severe 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
- Double (Participant, Investigator)
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
- •Healthy, male and non-pregnant female subjects, 18 years of age or older.
- •A diagnosis of papulopustular rosacea with ≥30 inflammatory facial lesions at Baseline. Subjects must have no more than 2 nodular lesions, at Baseline.
- •Subjects with the presence of telangiectasia at Baseline.
- •Subjects with an erythema score of at least 2 on the Investigator Assessment of Erythema scale at Baseline.
- •Subjects with severe rosacea on the Investigators Global Assessment scale at Baseline.
排除标准
- •Subjects with steroid rosacea or subtype 3 (phymatous rosacea).
- •Subjects with nodular rosacea.
- •Standard exclusion criteria.
研究组 & 干预措施
Treatment
Experimental
CLS001 (Omignan) gel applied once daily
干预措施: CLS001 (Omiganan) (Drug)
Vehicle Gel
Placebo Comparator
Vehicle gel applied once daily
干预措施: Vehicle (Drug)
结局指标
主要结局
Efficacy Absolute Change in Inflammatory Lesion Count
时间窗: 12 weeks
Absolute change in inflammatory lesion count from baseline to Week 12.
Efficacy IGA: 2 Grade Reduction
时间窗: 12 weeks
Proportion of Subjects Who Achieved 2 Grade IGA Reduction at Week 12. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).
次要结局
- Efficacy The Absolute Change in Inflammatory Lesions(6 weeks)
- Efficacy IGA: 2 Point Reduction(6 Weeks)
研究者
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