A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Efficacy and Safety of DSXS in Patients With Mild to Moderate Plaque Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2
研究概览
简要总结
The purpose of this study is to evaluate the therapeutic efficacy and safety of DSXS compared to a Placebo (vehicle) in patients with mild to moderate plaque psoriasis.
详细描述
To evaluate the therapeutic efficacy and safety of dsxs topical spray, 0.15% (Taro Pharmaceuticals, U.S.A., Inc.) compared to a Placebo (vehicle) spray (Taro Pharmaceuticals, U.S.A., Inc.) in patients with mild to moderate plaque 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
- 12 Years 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, 12 years of age or older, with a confirmed diagnosis of mild to moderate plaque psoriasis
排除标准
- •patient is< 12 years old.
研究组 & 干预措施
DSXS1505
To evaluate the therapeutic efficacy and safety of DSXS topical spray, 0.15%.
干预措施: DSXS (Drug)
DSXS1505
To evaluate the therapeutic efficacy and safety of DSXS topical spray, 0.15%.
干预措施: Placebo (Drug)
Placebo
Eligible patients will be randomized in a 1:1 ratio to Test or Placebo product.
干预措施: DSXS (Drug)
Placebo
Eligible patients will be randomized in a 1:1 ratio to Test or Placebo product.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2
时间窗: 28 Days
The number of patients in each treatment group that have clinical success. Clinical Success is at least a 2-grade improvement from the baseline IGA score. The minimum IGA value is 0, and maximum value is 5. A higher number represents a more severe case of plaque psoriasis. Patients are required to have an IGA score of 2 or 3 at baseline, so all clinical success IGA scores will be either 0 or 1.
Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2
时间窗: 28 Days
The number of patients in each treatment group that have Treatment Success for the Target Lesion based on the TLSS sub-scale scores. Treatment Success is defined as a score of 0 or 1 for each of the three signs and symptoms (erythema, scaling and plaque elevation) for the Target Lesion. Each score has a minimum value of 0 and maximum value of 5, where a higher value represents a more severe sign or symptom. To be considered for inclusion in the study, the Target Lesion must have a plaque elevation score of at least 2.
次要结局
- Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2 (Patients With a Baseline IGA Score of 3)(28 Days)
- Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2 (Patients With a Baseline IGA Score of 3)(28 Days)
- Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2 (Patients With a Baseline IGA Score of 2)(28 Days)
- Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2 (Patients With a Baseline IGA Score of 2)(28 Days)