A Randomized Double Blind Vehicle Controlled Dose Ranging Multiple Site Phase 2 Clinical Study to Evaluate the Efficacy and Safety of DSXS in Patients With Moderate to Severe Scalp Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 151
- 主要终点
- Clinical Response of Success
研究概览
简要总结
The objectives of this study are to evaluate the therapeutic efficacy and safety of DSXS and a Placebo in patients with moderate to severe scalp psoriasis.
详细描述
This randomized, double-blind, vehicle-controlled, dose-ranging, parallel-group multi-site study is designed to evaluate the therapeutic efficacy and safety of the investigational product, DSXS, for the treatment of moderate to severe scalp psoriasis at different application times up to 30 minutes.
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
- Double (Participant, Investigator)
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 or non-pregnant, non-lactating females age 12 and older.
- •Clinical diagnosis of moderate to severe scalp psoriasis, defined by a Investigator's Global Assessment score of at least 3 at screening.
排除标准
- •Under 12 years of age.
- •Patients whose scalp and/or non-scalp psoriasis necessitates systemic or other concomitant topical therapies during the study.
- •Has a scalp skin condition that would interfere with the diagnosis or assessment of plaque psoriasis of the scalp.
研究组 & 干预措施
DSXS1411
DSXS applied once a day for a total of 28 days.
干预措施: DSXS1411 (Drug)
Placebo
Placebo (vehicle) applied once a day for a total of 28 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical Response of Success
时间窗: 28 Days
The proportion of patients in each treatment group that have clinical success at Day 28, which is defined by a Investigator's Global Assessment score of 0 or 1.
次要结局
未报告次要终点