Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 400
- 试验地点
- 13
- 主要终点
- Incidence of adverse events of clinical interest (e.g. skin infections, skin irritation)
研究概览
简要总结
Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits the T-cell activation. These cells are involved in the inflammatory component of the disease. This study will test the safety of pimecrolimus Cream 1% with topical corticosteroid treatment (commonly used in eczema) in patients with 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
- 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
- •Severe atopic dermatitis
- •5% of total body surface area (TBSA) affected
排除标准
- •Concurrent skin diseases (infections)
- •Immunocompromised
- •Recently received phototherapy or systemic therapy
研究组 & 干预措施
1
Pimecrolimus 1 % cream plus topical corticosteroid (TCS)
干预措施: Pimecrolimus plus topical corticosteroid (TCS) (Drug)
2
Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)
干预措施: Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS) (Drug)
结局指标
主要结局
Incidence of adverse events of clinical interest (e.g. skin infections, skin irritation)
次要结局
- Incidence of all other adverse events
- Time to relapse of atopic dermatitis
- Time to treatment success according to the Investigators Global Assessment (IGA - a measure of disease severity)
- Efficacy measured by IGA (treatment success and improvement)
- Efficacy measured by improvement in Eczema Area and Severity Index (EASI - a measure of disease severity and extent