NCT00351052已完成3 期
A 24-Week, Randomized, Multicenter, Parallel-Group, Double-Blind, Vehicle-Controlled Study on Pimecrolimus Cream 1% Assessing the Steroid-Sparing Effect in the Long Term Management of Pediatric Patients With Severe Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 184
- 主要终点
- Corticoid-sparing effect of pimecrolimus cream 1%
研究概览
简要总结
This study will investigate the steroid sparing effect of pimecrolimus cream 1% in pediatric atopic dermatitis
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 (Participant, Investigator)
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients aged 2 to < 18 years with severe AD (score 8 or 9 according to Rajka and Langeland)
- •responded to 21 days of treatment with prednicarbate cream 0.25% during screening phase
排除标准
- •Patients who had received phototherapy, systemic or topical therapy or systemic corticosteroids shortly prior to study
研究组 & 干预措施
1
Experimental
Pimecrolimus
干预措施: Pimecrolimus (Drug)
2
Placebo Comparator
Vehicle
干预措施: Placebo (Drug)
结局指标
主要结局
Corticoid-sparing effect of pimecrolimus cream 1%
次要结局
- safety of pimecrolimus cream 1%
- atopic dermatitis control
- quality of life
研究者
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