NCT00568412已完成4 期
A Multicenter, Randomized, Double-blind Clinical Study to Examine the Efficacy and Safety of Zarzenda in Comparison to Elidel in the Management of Mild to Moderate Atopic Dermatitis in Children and Adolescents
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Investigator's Global Assessment
研究概览
简要总结
To show therapeutic efficacy of Zarzenda cream compared to Elidel cream in children and adolescents with mild to moderate 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 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and female children and adolescents (aged 2 - 17)
- •mild to moderate atopic dermatitis
- •patients in whom a treatment with topical corticosteroids in not recommended or possible
- •wash out periods to be observed
排除标准
- •known allergy to one of the two treatments
- •known immunodeficiency
- •known hepatic or renal insufficiency
- •acute skin infections
研究组 & 干预措施
1
Active Comparator
Zarzenda applied topically twice daily for three weeks
干预措施: Zarzenda (Device)
2
Active Comparator
Elidel 1% cream, applied topically twice daily for three weeks
干预措施: Elidel (Drug)
结局指标
主要结局
Investigator's Global Assessment
时间窗: End of study compared to baseline
次要结局
- Affected body surface area(End of study compared to baseline)
- Children's Dermatological Life Quality Index(End of study compared to baseline)
- EASI(End of study compared to baseline)
- Patient's assessment of itch, quality of sleep, and global assessment(End of study compared to baseline)
研究者
研究点 (1)
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