NCT02066545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 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
- 327
- 试验地点
- 20
- 主要终点
- Change in inflammatory lesion count from Baseline
研究概览
简要总结
The primary objective of this study is to evaluate the safety and efficacy of once-daily topical application of CLS001 1%, 1.75% and 2.5% topical gel compared to vehicle topical gel in subjects with 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
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant female subjects with facial acne vulgaris, 12 years of age or older.
- •Subjects with ≥20 inflammatory facial lesions (papules, pustules) inclusive of the nose, with a maximum of 9 inflammatory pustules.
- •An Investigator's Global Assessment (IGA) of Moderate (3) or Severe (4)
排除标准
- •Subjects with acne conglobate, acne fulminans, and secondary acne (chloracne, drug-induced acne, polycystic ovarian syndrome, etc.)
- •Subjects with greater that 75 facial non-inflammatory lesions (open and/or closed comedones; excluding the nose)
- •Subjects with more than 2 facial nodulocystic lesions
研究组 & 干预措施
Vehicle Gel
Placebo Comparator
干预措施: CLS001 Topical Gel Vehicle (Drug)
CLS001 topical gel 1%
Experimental
Topical application once daily
干预措施: CLS001 Topical Gel (Drug)
CLS001 topical gel 1.75%
Experimental
Topical application once daily
干预措施: CLS001 Topical Gel (Drug)
CLS001 topical gel 2.5%
Experimental
Topical application once daily
干预措施: CLS001 Topical Gel (Drug)
结局指标
主要结局
Change in inflammatory lesion count from Baseline
时间窗: 6, 9 and 12 weeks
次要结局
- Percent change from baseline at each visit in inflammatory lesions, non-inflammatory lesions and total lesions(1, 3, 6, 9 and 12 weeks)
- Absolute change from Baseline at each visit in inflammatory lesions, no-inflammatory lesions, and total lesions(1, 3, 6, 9 and 12 weeks)
- Percentage of subjects with an Investigator's Global Assessment (IGA) of clear or almost clear (0 or 1) at each visit(1, 3, 6, 9, and 12 weeks)
- Percentage of subjects with a 2 grade reduction in the IGA at each visit(1, 3, 6, 9, and 12 weeks)
研究者
研究点 (20)
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