NCT00248456已完成4 期
A Randomised, Double-blind, Active-controlled, Parallel, Multi-center Study to Investigate the Efficacy and Safety of Daivobet® Ointment in Patients With Psoriasis Vulgaris
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- The percentage change of PASI at the end of week 4 compared with baseline
研究概览
简要总结
This study will evaluate the efficacy and safety of calcipotriol plus betamethasone dipropionate ointment compared with calcipotriol ointment in the treatment of patients with psoriasis vulgaris for a duration of 4 weeks. The study will focus on the percentage change of the psoriasis area and severity index (PASI) from baseline to the end of week 4.
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
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of psoriasis vulgaris in a stable condition
- •Extent of at least 10% of one or more body regions
- •Amenable to topical therapy with maximum of 100 g/week of investigational product
排除标准
- •Patients with more than 30% of body surface area involved
- •Patients with facial psoriasis who need treatment
- •Patients who need treatment of scalp psoriasis with WHO group IV topical corticosteroids, tretinoin or topical vitamin D derivatives
- •Patients with unstable forms of psoriasis including guttate, erythrodermic, pustular, or arthritis psoriasis
- •Systemic treatment of psoriasis with corticosteroids or other therapy
- •Systemic antipsoriatic treatment (e.g. corticosteroids, immunosuppressive drugs, tretinoin, antibiotics, phototherapy or calcium agents) within 4 weeks prior to visit 1; or topical antipsoriatic treatment (e.g. keratolytics, topical corticosteroids, topical vitamin D derivatives, anthralin, crude coal tar, etc) within the previous 2 week period
- •Patients with planned exposure to phototherapy that may affect the psoriasis during the study period
结局指标
主要结局
The percentage change of PASI at the end of week 4 compared with baseline
次要结局
- The change of PASI at the end of week 4 compared with baseline
- The change of Dermatology Life Quality Index at the end of week 4 compared with baseline
- Physician's Global Assessment at the end of week 4
- Patient's assessment by Visual Analogue Scale (VAS) at the end of week 4
- The change of individual scores of redness, thickness, and scaliness at the end of week 4 on the target lesion compared with baseline
- The change of overall lesion area percentage (scalp and face area excluded) at the end of week 4 compared with baseline
研究者
研究点 (1)
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