NCT02932462已完成3 期
A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Design, Multiple-Site, Phase III Clinical Study to Evaluate the Efficacy and Safety of DSXS 1535 in Patients With Mild to Severe Scalp Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 373
- 主要终点
- Clinical Success in Patients With Moderate and Severe Scalp Psoriasis
研究概览
简要总结
A Randomized Double-Blind, Vehicle-Controlled, Parallel Design, Multiple-Site, Phase III Clinical Study
详细描述
This randomized, double-blind, vehicle-controlled, parallel-group multiple-site study is designed to evaluate the therapeutic efficacy and safety of the investigational product, DSXS 1535 product, for the treatment of 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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a clinical diagnosis of mild to severe plaque psoriasis of the scalp, defined by an Investigator's Global Assessment (IGA) score of at least 2 at baseline/randomization
排除标准
- •Patients whose scalp psoriasis necessitates systemic or other concomitant topical therapies during the study (concomitant treatment of body psoriasis with over the counter topical products including emollients, is allowed).
- •Patient has a scalp skin condition that would interfere with the diagnosis or assessment of plaque psoriasis of the scalp (e.g., seborrheic dermatitis, eczema, cutaneous T-cell lymphoma, or other forms of psoriasis including guttate, inverse, pustular or erythrodermic psoriasis)
- •Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the treatment areas that could interfere with the rating of efficacy parameters, including planned extensive exposure to sunlight during the study.
- •History of psoriasis unresponsive to topical treatments.
- •Current immunosuppression or history of organ transplant.
- •Patients who have a history of or current diagnosis of glaucoma.
- •Patients who have had surgery on the eyes or eyelids within 1 month before baseline or plan to have eye or eyelid surgery during the study.
- •Patients with active infection (including but not limited to bacterial, fungal and viral infection) and/or open wounds on the entire head and neck area.
研究组 & 干预措施
DSXS 1535
Experimental
DSXS 1535 topical product
干预措施: DSXS (Drug)
Placebo
Placebo Comparator
Vehicle
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical Success in Patients With Moderate and Severe Scalp Psoriasis
时间窗: from baseline to study day 29
IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline
Clinical Success in Patients With Mild to Severe Scalp Psoriasis
时间窗: from baseline to study day 29
IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline
次要结局
- Clinical Success in Patients With Mild Scalp Psoriasis(from baseline to study day 29)
研究者
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