NCT02709902已完成1 期
A Multi-center, Double-blind, Randomized, Placebo, Controlled, Parallel-group Study, Comparing Adapalene/BP Gel, 0.3%/2.5% to EPIDUO® FORTE GEL and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 460
- 主要终点
- Change in inflammatory lesion counts
研究概览
简要总结
Bioequivalence with Clinical Endpoints.
详细描述
Randomized, Double-Blind, Placebo-Controlled, Multiple-Site, Parallel Design, Bioequivalence with Clinical Endpoints.
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 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy male or non pregnant female aged ≥ 12 and ≤ 40years with a clinical diagnosis of acne vulgaris.
排除标准
- •Female Subjects who are pregnant, nursing or planning to become pregnant during study participation
研究组 & 干预措施
Adapalene/BP gel, 0.3%/2.5%
Experimental
Topical, once daily, for 84 days.
干预措施: Adapalene/BP gel, 0.3%/2.5% (Drug)
EPIDUO® FORTE
Active Comparator
Topical, once daily, for 84 days.
干预措施: EPIDUO® FORTE (Drug)
Placebo
Placebo Comparator
Topical, once daily, for 84 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in inflammatory lesion counts
时间窗: Week 12
Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts
Change in non-inflammatory lesion counts
时间窗: Week 12
Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts
次要结局
- Clinical response of success(Week 12)
研究者
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