A Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-group Study to Evaluate the Efficacy and Safety of ADPS in the Treatment of Acne Vulgaris
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 294
- 主要终点
- Percent Change From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts on the Face
研究概览
简要总结
Safety and efficacy study in patients with acne vulgaris
详细描述
randomized, double-blind, placebo controlled, parallel-group, multiple-center study to evaluate the efficacy and safety of ADPS 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 —（Child, 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 ≥ 9 years with a clinical diagnosis of acne vulgaris
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
ADPS topical product
A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks
干预措施: ADPS topical product (Drug)
Placebo Control
A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks
干预措施: Placebo Control (Drug)
结局指标
主要结局
Percent Change From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts on the Face
时间窗: Baseline to week 12 (study day 84)
Percent Change From Baseline to Week 12 in the Non-inflammatory (Open and Closed Comedones) Lesion Counts on the Face
时间窗: Baseline to week 12 (study day 84)
The Percentage of Subjects With a Clinical Response (IGA) of "Success" at Week 12 on the Face.
时间窗: Baseline to Week 12 (study day 84)
Success was defined as an IGA score that was at least two grades less than the baseline assessment.
次要结局
未报告次要终点