EUCTR2005-001650-25-DE进行中（未招募）不适用
A 12 week multicenter study consisting of a 6 week double blind, randomized, vehicle controlled, parallel group phase, followed by a 6 week open label phase, to assess the efficacy and safety of Elidel® Cream 1% in mild to moderate facial atopic dermatitis of patients (2 to 11 years of age, inclusive) intolerant of, or dependent on, topical corticosteroids
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 216
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 2 to 11 years of age, inclusive
- •- Mild to moderate facial AD at screening (facial IGA 2 – 3; based on assessment of the face only and excluding the ears and the neck).
- •- Patients intolerant of, or dependent on, topical corticosteroids
- •- Diagnosis of AD fulfilling the Hanifin and Rajka criteria
- •- For female patients, a negative pregnancy test. Women who are pregnant or who are breast-feeding may not be included in the study. Women of child-bearing potential must follow a medically recognized form of contraception.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •At baseline, patients :
- •- with AD on greater than 30% of total body surface area
- •- with concurrent skin disease (e.g. acne) in the study area or active skin infections or other conditions that may interfere with the evaluation
- •- who are immunocompromised (e.g. Lymphoma, AIDS, Wiskott-Aldrich Syndrome) or with a history of malignant disease
- •- with previously reported poor, no clinical response or hypersensitivity to topical calcineurin inhibitors such as pimecrolimus cream (Elidel®) and tacrolimus cream (Protopic®)
- •- who received phototherapy (e.g. UVA, UVB) or systemic therapy (e.g. immunosuppressants, corticosteroids, cytostatics) known or suspected to have an effect on AD within 4 weeks of Visit 2
- •- who received investigational drugs within 8 weeks of first application of study drug or planned use of other investigational drugs during participation of this study
- •- who are unlikely to comply with therapy
研究者
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