NCT00130364已完成4 期
Efficacy and Safety of Pimecrolimus Cream 1% in Patients (2 to 11 Years Old) With Mild to Moderate Facial 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
- 发起方
- Novartis
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The percentage of patients who have a facial Investigator's Global Assessment (IGA) score of 0 or 1 (clear or almost clear)
研究概览
简要总结
This study is not being conducted in the United States of America (USA).
Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits T-cell activation. These cells are involved in the inflammatory component of the disease. This study will test the safety and efficacy of pimecrolimus cream 1% in atopic dermatitis of the face in patients intolerant of, or dependent on, topical corticosteroids.
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 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate facial atopic dermatitis
- •Patients intolerant of, or dependent on, topical corticosteroids
排除标准
- •Concurrent skin diseases (infections)
- •Immunocompromised
- •Recently received phototherapy or systemic therapy
研究组 & 干预措施
1
Experimental
Pimecrolimus
干预措施: Pimecrolimus (Drug)
2
Placebo Comparator
Pimecrolimus vehicle cream
干预措施: Placebo (Drug)
结局指标
主要结局
The percentage of patients who have a facial Investigator's Global Assessment (IGA) score of 0 or 1 (clear or almost clear)
次要结局
- Percentage of patients who responded to treatment assessed by overall Eczema Area and Severity Index (EASI) and head and neck EASI score
- The percentage of patients achieving at least a 60 % reduction from baseline in the head and neck EASI score
- The percentage of patients achieving a score of 0 or 1 for pruritus (absent or mild)
- Time to clearance of facial IGA (score of 0 or 1)
研究者
研究点 (1)
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