NCT00666159已完成4 期
A Randomized, Investigator Blinded Study of Protopic (Tacrolimus) Ointment Vs. Elidel (Pimecrolimus) Cream in Pediatric Patients With Moderate to Severe 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
- 226
- 主要终点
- Change Eczema Area and Severity Index (EASI)
研究概览
简要总结
Comparison of Protopic Ointment to Elidel Cream to assess the safety and efficacy in pediatric patients with Atopic Dermatitis
详细描述
This is a two arm, randomized, investigator blinded study to compare Protopic Ointment to Elidel Cream in treating pediatric patients with moderate to severe 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
- 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
- •Diagnosis of Atopic Dermatitis which is rated moderate, severe or very severe using the Investigator's Global Atopic Dermatitis Assessment involving a minimum of 5% of the body's 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 Eczema Area and Severity Index (EASI)
时间窗: 6 Weeks
次要结局
- Investigator's Global Atopic Dermatitis Assessment (IGADA)(6 Weeks)
- Body surface area affected(6 Weeks)
- Patient's evaluation of itch(6 Weeks)
研究者
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