NCT01342315已完成3 期
A Randomized, Multi-Center, Double-Blind, Vehicle-Controlled Study Evaluating the Efficacy and Safety of Product 33525 in Subjects With Tinea Cruris
Medicis Global Service Corporation0 个研究点目标入组 483 人开始时间: 2011年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 483
- 主要终点
- Proportion of patients achieving complete clearance
研究概览
简要总结
To determine if a topical antifungal cream is safe and effective for the treatment of tinea cruris
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •moderate erythema, mild scaling, and moderate pruritis
排除标准
- •pregnancy and allergies
研究组 & 干预措施
Active
Experimental
Product 33525
干预措施: 33525 (Drug)
Placebo
Experimental
Product 33525 Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of patients achieving complete clearance
时间窗: 3 weeks post-treatment
Signs and Symptoms Severity Score and negative Potassium Hydroxide (KOH) and Culture
次要结局
- Proportion of patients achieving effective treatment(1 week Post Treatment, 2 weeks Post Treatment, and 3 weeks Post Treatment)
研究者
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