NCT00437619已完成4 期
An Open Label Study to Evaluate the Clinical Response to Sequential Treatment With Daivobet and Daivonex in Patients With Mild to Moderate Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- PASI reduction
研究概览
简要总结
This single arm study will evaluate the efficacy and safety of sequential treatment with Diavobet (betamethasone propionate 0.5mg/g plus calcipotriol hydrate 50 micrograms/g) once daily for 4 weeks followed by Daivonex (calcipotriol hydrate 50 micrograms/g) twice daily for 4 weeks, in the control of signs and symptoms in patients with mild to moderate psoriasis. Only patients showing a >50% response to Daivobet will progress to the Daivonex maintenance phase. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •adult patients >=18 years of age;
- •clinical diagnosis of psoriasis vulgaris;
- •PASI score 1-12 in >=1 body area.
排除标准
- •clinical presentation of erythrodermic pustular psoriasis, expressed in plates and localized lesions on face and/or scalp;
- •viral, fungal or bacterial skin infections;
- •use of any topical treatment for psoriasis within previous 15 days;
- •use of any systemic therapy and phototherapy for psoriasis within previous 30 days.
研究组 & 干预措施
1
Experimental
干预措施: calcipotriol hydrate [Daivonex] (Drug)
结局指标
主要结局
PASI reduction
时间窗: Weeks 4 and 8
次要结局
- AEs.(Throughout study)
研究者
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