A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Taro Product to RLD, and Both Active Treatments to a Placebo Control in the Treatment of Moderate Facial Rosacea
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 1,116
- 试验地点
- 1
- 主要终点
- change in the inflammatory lesion counts
研究概览
简要总结
To demonstrate the superiority of the efficacy of the test and reference products over that of the placebo control in the treatment of moderate facial rosacea.
详细描述
A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group study, comparing test and reference products and both active treatments to a placebo control in the treatment of Moderate Facial 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or non-pregnant female aged ≥ 18 with a clinical diagnosis of facial rosacea.
- •Subjects must have provided IRB approved written informed consent.
排除标准
- •Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
- •Subjects who have used estrogens or oral contraceptives for less than 3 months prior to baseline; use of such therapy must remain constant throughout the study.
研究组 & 干预措施
Azelaic acid foam 15%
Topical, twice daily (Apply the foam (morning and evening) to the entire facial area (cheeks, chin, forehead, and nose).
干预措施: Azelaic acid foam 15% (Drug)
Finacea® (azelaic acid) Foam, 15%
Topical, twice daily (Apply the foam (morning and evening) to the entire facial area (cheeks, chin, forehead, and nose).
干预措施: Finacea® (Azelaic acid Foam) 15% (Drug)
Vehicle of the test product
Topical, twice daily (Apply the foam (morning and evening) to the entire facial area (cheeks, chin, forehead, and nose).
干预措施: Vehicle of the test product (Drug)
结局指标
主要结局
change in the inflammatory lesion counts
时间窗: 12 weeks
Percent change from baseline to Week 12 in the inflammatory (papules and pustules) lesion counts
次要结局
未报告次要终点