NCT02393937已完成3 期
A Multi-center, Double-blind, Randomized, Vehicle-controlled, Parallel-group Study Comparing Metronidazole Gel 1%, to Metrogel® (Metronidazole Gel) 1% in the Treatment of Rosacea
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
- bioRASI, LLC
- 入组人数
- 963
- 主要终点
- To compare the test and reference products of metronidazole topical gel 1% with regard to the mean percent change from Baseline of the inflammatory lesion counts of rosacea.
研究概览
简要总结
The purpose of this study is to compare the efficacy of two Metronidazole Gels 1%, in the treatment of Rosacea.
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
- •Male or Female subjects with at least 18 years of age;
- •Read and signed ICF;
- •Clinical Diagnosis of Rosacea;
排除标准
- •Females who are pregnant, lactating or of childbearing potential who are not using or do not agree to use an acceptable form of contraception;
- •Any skin condition that would interfere with treatment of rosacea
- •Use of prohibited medications
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo Gel once daily for 70 days.
干预措施: Placebo Gel (Drug)
结局指标
主要结局
To compare the test and reference products of metronidazole topical gel 1% with regard to the mean percent change from Baseline of the inflammatory lesion counts of rosacea.
时间窗: 70 Days
次要结局
- To compare the test and reference product of metronidazole topical gel 1% with regard to the Investigator's Global Evaluation (IGE) of disease severity(70 Days)
研究者
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