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临床试验/NCT00216892
NCT00216892已完成4 期

Different Treatment Regimens of Calcipotriol Cream and Combination (Calcipotriol/Betamethasone Dipropionate) Ointment in Psoriasis Vulgaris

LEO Pharma14 个研究点 分布在 7 个国家目标入组 1,032 人开始时间: 2005年4月最近更新:
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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
1,032
试验地点
14
主要终点
Efficacy of regimen (a) versus regimen (c) by % change in PASI at week 12
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Patients with psoriasis vulgaris of the trunk and/or limbs are randomised to treatment with:

  1. 4 weeks of ointment containing calcipotriol and betamethasone dipropionate followed by 8 weeks of calcipotriol cream
  2. 4 weeks of (calcipotriol plus betamethasone dipropionate) ointment followed by 8 weeks of calcipotriol cream on weekdays/ (calcipotriol plus betamethasone dipropionate) ointment on weekends
  3. 4 weeks of (calcipotriol plus betamethasone dipropionate) ointment followed by 8 weeks of vehicle of calcipotriol cream

The objective is to compare the efficacy and safety of the different treatment regimens

详细描述

A phase IV study of different treatment regimens of calcipotriol 50 mcg/g cream and combination (calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)) ointment following treatment with combination ointment in psoriasis vulgaris

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 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Patients with psoriasis vulgaris of trunk and/or limbs

排除标准

  • 未提供

结局指标

主要结局

Efficacy of regimen (a) versus regimen (c) by % change in PASI at week 12

次要结局

  • Efficacy of regimen (b) versus regimen (c) at week 12, safety of regimen (a) versus (c), safety of regimen (b) versus (c)

研究者

发起方
LEO Pharma
申办方类型
Industry

研究点 (14)

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Different treatment regimens of calcipotriol cream and combination (calcipotiol/betamethasone dipropionate) ointment in psoriasis vulgarisPsoriasis vulgaris of the trunk and/or limbs with at least 10% involvement of arms and/or 10% of legs and/or 10% of trunkMedDRA version: 7.0 Level: LLT Classification code 10050576
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Different treatment regimens of calcipotriol cream and combination (calcipotiol/betamethasone dipropionate) ointment in psoriasis vulgarisPsoriasis vulgaris of the trunk and/or limbs with at least 10% involvement of arms and/or 10% of legs and/or 10% of trunkMedDRA version: 7.0Level: LLTClassification code 10050576
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