A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Design, Multiple-Site, Phase III Clinical Study to Evaluate the Efficacy and Safety of DSXS Topical Product in Patients With Mild to Severe Scalp Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 371
- 试验地点
- 1
- 主要终点
- Proportion of Patients in Each Treatment Group Who Are Considered a Clinical Success
研究概览
简要总结
A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Design, Multiple-Site, Phase III Clinical Study to Evaluate the Efficacy and Safety of DSXS topical product in Patients with Mild to Severe Scalp Psoriasis
详细描述
To evaluate the therapeutic efficacy and safety of DSXS topical product (Taro Pharmaceuticals, U.S.A., Inc.) compared to a Vehicle topical product (Taro Pharmaceuticals, U.S.A., Inc.) in patients with mild to severe scalp psoriasis.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or non-pregnant, non-lactating females 18 years of age and older.
排除标准
- •Females who are pregnant, lactating or likely to become pregnant during the study.
研究组 & 干预措施
DSXS topical
applied once daily for 28 days
干预措施: DSXS topical (Drug)
Vehicle topical
applied once daily for 28 days
干预措施: Vehicle topical (Drug)
结局指标
主要结局
Proportion of Patients in Each Treatment Group Who Are Considered a Clinical Success
时间窗: Day 29
Clinical Success is defined by an IGA score of 0 (clear) or I (almost clear) with at least a 2 grades reduction from baseline at Day 29 ± 2
次要结局
未报告次要终点