A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing TRETINOIN CREAM, 0.1% to RETIN-A® (TRETINOIN) CREAM, 0.1% and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 455
- 试验地点
- 1
- 主要终点
- Demonstration of Bioequivalence
研究概览
简要总结
Bioequivalence study comparing Tretinoin Cream, 0.1% to RETIN-A®.
详细描述
A Multi-center, Double-Blind, Randomized, Placebo controlled, Parallel-Group study, comparing TRETINOIN CREAM, 0.1% (TARO PHARMACEUTICALS U.S.A., INC.) to RETIN-A® (TRETINOIN) CREAM, 0.1% (VALEANT) and both active treatments to a Placebo Control in the treatment of Acne Vulgaris
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 (Investigator)
入排标准
- 年龄范围
- 12 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
- •Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA).
- •Subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits.
排除标准
- •Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
研究组 & 干预措施
Tretinoin cream 0.1%
Once daily at home, to apply the entire affected areas of the face.
干预措施: Tretinoin cream 0.1% (Drug)
RETIN-A® Cream
Once daily at home, to apply the entire affected areas of the face.
干预措施: RETIN-A® Cream (Drug)
Vehicle of the test product
Once daily at home, to apply the entire affected areas of the face.
干预措施: Vehicle of the test product (Drug)
结局指标
主要结局
Demonstration of Bioequivalence
时间窗: 12 weeks
Demonstration of Bioequivalence in Percent change in inflammatory and non-inflammatory lesion counts
次要结局
未报告次要终点