NCT00667160已完成4 期
A Randomized, Investigator Blinded Study of Protopic (Tacrolimus) Ointment Vs. Elidel (Pimecrolimus) Cream in Pediatric Patients With Mild Atopic Dermatitis
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
- 426
- 主要终点
- Change in Eczema Area and Severity Index (EASI)
研究概览
简要总结
A study to compare the safety and efficacy of Protopic and Elidel in treating mild Atopic Dermatitis in pediatric patients
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
- Single (Investigator)
入排标准
- 年龄范围
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has a diagnosis of Atopic Dermatitis rated mild using the Investigator's Global Atopic Dermatitis Assessment involving a minimum of 5% of the body surface area, and the maximum of 20% of the body surface area
- •If female, and of childbearing potential, patient has a negative pregnancy test and agrees to practice effective birth control during the study
排除标准
- •Patient has a skin disorder other than Atopic Dermatitis in the areas to be treated
- •Patient has extensive scarring or pigmented lesions in the areas to be treated that would interfere with rating of efficacy parameters
- •Patient has clinically infected Atopic Dermatitis at baseline
- •Patient is likely to require systemic corticosteroids, or the patient is likely to require intranasal or inhaled corticosteroids for an off-label indication or at higher doses than the maximum labeled dosing for the drug
- •Patient has a known hypersensitivity to macrolides or any excipient of either study medication
- •Patient has a chronic condition which is either not stable or not well controlled
- •Patient is pregnant or breast feeding an infant
研究组 & 干预措施
1
Experimental
干预措施: tacrolimus ointment (Drug)
2
Active Comparator
干预措施: pimecrolimus cream (Drug)
结局指标
主要结局
Change in Eczema Area and Severity Index (EASI)
时间窗: 6 Weeks
次要结局
- Patient's evaluation of itch(6 Weeks)
- Body surface area affected(6 Weeks)
- Investigator's Global Atopic Dermatitis Assessment (IGADA)(6 Weeks)
研究者
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