NCT00666900已完成2 期
A Phase 2, Multicenter, Randomized, Double-Blind, Dose-Ranging Study to Evaluate IDP-107 Versus Placebo in the Treatment of Severe Acne Vulgaris With Nodules
Dow Pharmaceutical Sciences25 个研究点 分布在 1 个国家目标入组 366 人开始时间: 2008年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 366
- 试验地点
- 25
- 主要终点
- Change from baseline in the number of inflammatory lesions
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness of IDP-107 in treating patients with 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
- •Presence of inflammatory and non-inflammatory lesions
排除标准
- •Dermatological conditions of the face that could interfere with clinical evaluations
- •Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study
研究组 & 干预措施
1
Experimental
干预措施: Low Strength IDP-107 (Drug)
2
Experimental
干预措施: High Strength IDP-107 (Drug)
3
Placebo Comparator
干预措施: Placebo Comparator (Drug)
结局指标
主要结局
Change from baseline in the number of inflammatory lesions
时间窗: 12 weeks
Improvement from baseline in global severity
时间窗: 12 weeks
次要结局
- Change from baseline in the number of non-inflammatory lesions(12 weeks)
研究者
研究点 (25)
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