NCT03553433Unknown4 期
A Phase 4 Multicenter, Randomized, Placebo-controlled Study Evaluating the Effect of Apremilast on Pruritus and Quality of Life of Patients With Moderate-to-severe Scalp Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Scalp VAS Pruritus assessment
研究概览
简要总结
A phase 4 multicenter, randomized, placebo-controlled Study evaluating the Effect of Apremilast on Pruritus and Quality of Life of Patients with moderate-to-severe Scalp Psoriasis
详细描述
The scalp is the most frequently affected body region in psoriasis. Scalp Psoriasis can impair the quality of life greatly due to pruritus. This is however not usually investigated as a primary outcome of treatments.
This study will investigate the effects of apremilast on the pruritus and quality of life and other patient reported outcomes in patients with 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)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Verum
Experimental
Apremilast 30mg bd
干预措施: Apremilast 30mg (Drug)
Placebo Oral Tablet
Placebo Comparator
Excipiens
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Scalp VAS Pruritus assessment
时间窗: Weeks 16
Pruritus VAS Scale (0 - 100)
次要结局
- Scalp VAS Pruritus assessment(Weeks 0, 4, 32, 52)
- % BSA(Weeks 0, 4, 16, 32, 52)
- Scalp-PGA(Weeks 0, 4, 16, 32, 52)
- PGA(Weeks 0, 4, 16, 32, 52)
- PSSI(Weeks 0, 4, 16, 32, 52)
- PrecisePASI(Weeks 0, 4, 16, 32, 52)
- % BSA of scalp(Weeks 0, 4, 16, 32, 52)
- DLQI(Weeks 0, 4, 16, 32, 52)
- Scalpdex(Weeks 0, 4, 16, 32, 52)
- VAS pruritus assessment(Weeks 0, 4, 16, 32, 52)
- EQ-5D(Weeks 0, 4, 16, 32, 52)
研究者
研究点 (4)
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