NCT01016782已完成3 期
Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel Group Study of 0444 Gel
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 867
- 主要终点
- Reduction in the number of papules and pustules from Baseline to End of Treatment
研究概览
简要总结
The aim of this trial is to assess the efficacy of Metronidazole Topical Gel 1% in the Treatment of Inflammatory Lesions of Rosacea.
Treatment medication will be administered as follows: A thin film of gel will be applied and rubbed into the entire face once daily for a period of 70 days.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of rosacea
- •Good health with the exception of rosacea
- •Papsules and pustules minimum and maximum requirements
排除标准
- •Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
- •Subjects who have any systemic or dermatological disorders with the exception of rosacea
研究组 & 干预措施
Test
Experimental
Test product that contains active pharmaceutical ingredient
干预措施: 0444 (Drug)
Reference
Active Comparator
Reference product that contains active pharmaceutical ingredient
干预措施: 0444 (Drug)
Vehicle
Placebo Comparator
Placebo that contains no active pharmaceutical ingredient
干预措施: 0444 (Drug)
结局指标
主要结局
Reduction in the number of papules and pustules from Baseline to End of Treatment
时间窗: 70 Days
次要结局
- Reduction in the Investigator's Global Evaluation, Clear or Almost Clear(70 Days)
研究者
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