A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Azeliac Acid Gel and 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
- 1,000
- 主要终点
- Change in inflammatory lesion counts
研究概览
简要总结
A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study
详细描述
A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, comparing AZELAIC ACID TOPICAL GEL 15% TO FINACEA® and both active treatments to a Placebo Control in the treatment of Moderate of 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
- Single (Participant)
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 ≥ 18 years-of-age with a clinical diagnosis of moderate facial rosacea;
- •Subjects had to have a definite clinical diagnosis of facial rosacea severity Grade 3 as per the IGE
排除标准
- •Female subjects who were pregnant, nursing, or planning to become pregnant during study participation;
研究组 & 干预措施
Azelaic Acid 15% topical gel
Topical, twice daily, for 84 days A thin layer of study treatment was gently massaged into the affected areas on the face
干预措施: Azelaic Acid 15% topical gel (Drug)
Finacea® (azelaic acid) Gel, 15%
Topical, twice daily, for 84 days A thin layer of study treatment was gently massaged into the affected areas on the face
干预措施: Finacea® (azelaic acid) Gel, 15% (Drug)
Placebo
Topically to the face, twice a day A thin layer of study treatment was gently massaged into the affected areas on the face
干预措施: Placebo (Drug)
结局指标
主要结局
Change in 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