NCT01194375已完成2 期
A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris
Dow Pharmaceutical Sciences20 个研究点 分布在 2 个国家目标入组 180 人开始时间: 2010年9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
- 180
- 试验地点
- 20
- 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 evaluate the safety and efficacy of IDP-107 versus placebo 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 acne vulgaris on the face and neck/trunk
- •Presence of inflammatory and non-inflammatory lesions on the face
排除标准
- •Presence of any skin condition on the face that could interfere with clinical evaluations
- •Use of any systemic antibiotics or corticosteroids within 4 weeks prior to the Baseline visit
- •Use of any systemic retinoids, such as isotretinoin, within 3 months prior to the Baseline visit
- •Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period
研究组 & 干预措施
Low Strength IDP-107
Experimental
干预措施: Low Strength IDP-107 (Drug)
High Strength IDP-107
Experimental
干预措施: High Strength IDP-107 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in the number of inflammatory lesions
时间窗: Baseline and 22 weeks
Percent of patients who achieve success for the acne global severity score
时间窗: Baseline and 22 weeks
次要结局
- Change from baseline in the number of non-inflammatory lesions(Baseline and 22 weeks)
研究者
研究点 (20)
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