NCT00509990已完成4 期
Open Label Multicenter Study, 52 Weeks Duration, Using Pimecrolimus Cream 1% for the Long-term Treatment of Mild to Moderate Atopic Dermatitis in Pediatric Patients Within a Usual Clinical Setting
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- To evaluate the effectiveness of pimecrolimus cream 1% in the long-term management in mild to moderate atopic dermatitis in pediatric patients in a daily practice, as assessed by: • Investigator Global Assessment • Facial Investigator Global Ass
研究概览
简要总结
An open-label, multicenter study, of long term management to evaluate effectiveness, tolerability and safety of pimecrolimus cream 1% in pediatric patients with mild to moderate atopic dermatitis in a daily practice
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 3 months to 12 years old
- •Clinical diagnosis of atopic dermatitis
- •History of mild to moderate atopic dermatitis
- •Investigator Global Assessment ≥ 1 (almost clear/clear of disease)
- •Written informed consent
排除标准
- •Investigator Global Assessment ≥ 4 (severe/very severe disease)
- •Patients with active skin viral infections (i.e, herpes simplex, herpes zoster, varicella)
- •Patients with atopic dermatitis, with active clinical infection on area of disease. All active infections must be treated prior to trial inclusion
- •Patients in an Immunosuppressive state or with history of malignant disease
- •Patients with clinical conditions other that Atopic Dermatitis that according to the investigator may interfere with the evaluation (i.e, Psoriasis, Netherton Syndrome)
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
To evaluate the effectiveness of pimecrolimus cream 1% in the long-term management in mild to moderate atopic dermatitis in pediatric patients in a daily practice, as assessed by: • Investigator Global Assessment • Facial Investigator Global Ass
次要结局
- • To monitor the safety of pimecrolimus cream 1% in the long-term management as assessed by Adverse Events and Serious Adverse Events collection • To evaluate quality of life of both parent and patient assessed by questionnaire. • To determine ste
研究者
研究点 (6)
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