NCT01996748已完成3 期
A Multicenter, Randomized, Parallel, Double-blind, Clinical Trial Study to Assess the Efficacy and Safety of DF277 Compared to Placebo in Patients With Otic Eczema
Salvat1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2012年2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
- 135
- 试验地点
- 1
- 主要终点
- Analysis of the Itching Change at the End of Treatment.
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of DF277 for the treatment of otic eczema.
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
- •12 years or older
- •Clinical diagnosis of otic eczema suitable for local treatment
排除标准
- •Other diseases.
研究组 & 干预措施
DF277
Experimental
Two administrations daily for 7 days
干预措施: DF277 (Drug)
Placebo
Placebo Comparator
Two administrations daily for 7 days
干预措施: Placebo (Drug)
结局指标
主要结局
Analysis of the Itching Change at the End of Treatment.
时间窗: Baseline and days 4-8
The analysis of the itching change at the end of treatment (mean itching on days 4-8 compared to baseline). Itching was assessed on a 4 point ordinal scale; 0=absent, 1=mild, 2=moderate, 3=severe
次要结局
- Change in Mean Global Scores of Otoscopic Signs (Erythema, Edema and Scaling) at the End of Treatment (Day 8) Compared to Baseline (Day 1).(Baseline and day 8)
- Change in Mean Global Scores of Otoscopic Signs (Erythema, Edema and Scaling) at the End of Follow-up (Day 15) Compared to Baseline (Day 1).(Baseline and day 15)
- Change in Signs/ Symptoms(Baseline and days 9-15)
研究者
研究点 (1)
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