A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Efficacy and Safety of DSXS in Patients With Moderate to Severe Atopic Dermatitis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- The Number of Patients in Each Treatment Group That Have Clinical Success
研究概览
简要总结
Efficacy and Safety of DSXS (Taro Pharmaceuticals, U.S.A., Inc.) in Patients with Moderate to Severe Atopic Dermatitis
详细描述
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Efficacy and Safety of DSXS (Taro Pharmaceuticals, U.S.A., Inc.) in Patients with Moderate to Severe Atopic Dermatitis
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
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and non-pregnant females, age 6 months or older, with a confirmed diagnosis of moderate to severe atopic dermatitis (AD)
排除标准
- •Lacks stable diagnosis of atopic dermatitis or has been diagnosed with mild atopic dermatitis.
研究组 & 干预措施
DSXS topical product
DSXS Active treatment
干预措施: DSXS (Drug)
Placebo topical product
Placebo treatment
干预措施: Placebo (Drug)
结局指标
主要结局
The Number of Patients in Each Treatment Group That Have Clinical Success
时间窗: 28 days
Clinical Success defined using the following scores at Visit 4 (Day 28 ± 2): At least a 2-grade improvement from the baseline IGA score (i.e., clear \[0\] or almost clear \[1\]) AND A score of clear or mild (0 or 1) for both erythema and induration/papulation/edema
次要结局
- Change From Baseline in %BSA Affected at Day 28 ± 2(28 days)