A Single-center, Double-blind, Randomized, Parallel-group Study, Comparing DPSG to a Placebo Control in the Treatment of Acne Vulgaris
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 1,125
- 主要终点
- Change in inflammatory lesion counts
研究概览
简要总结
To evaluate the therapeutic effect of DPSG and Placebo gel in the treatment of acne vulgaris.
详细描述
A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group study comparing DPSG to ACZONE Gel and active treatment 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or non pregnant female aged ≥ 12 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
DPSG 7.5%
DPSG 7.5% (Taro Pharmaceuticals USA)
Topical, twice daily on the face for 84 days.
干预措施: DPSG 7.5% (Drug)
Vehicle Gel
Placebo product (Taro Pharmaceuticals Inc.)
Topical, twice daily on the face for 84 days.
干预措施: Placebo (Drug)
Aczone
dapsone 7.5
Topical, twice daily on the face for 84 days.
干预措施: Aczone (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
Change in non-inflammatory lesion counts
时间窗: 12 weeks
Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts
次要结局
- Clinical response of success(12 weeks)