An Investigation of the Safety and Efficacy of Elidel® 1% Cream in Atopic Disease Modification, Assessed in a 3-year Randomized Double-blind Vehicle Controlled Phase to Evaluate Effects on Atopic Dermatitis in Infants, and a 2-3 Year Open-label Phase to Evaluate the Effect of Early Intervention Versus Delayed Intervention With Elidel® on the Incidence of Asthma in Children
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1,091
- 试验地点
- 36
- 主要终点
- Atopic Dermatitis (AD) Disease Control Over 36 Months
研究概览
简要总结
This study consists of a 3-year double-blind phase during which patients will receive atopic dermatitis (AD) treatment either with pimecrolimus cream 1% long-term management (LTM) or with a conventional corticosteroid-based treatment (1:1 ratio), followed by a 2 to 3-year open-label (OL) phase (all patients receiving pimecrolimus cream 1% LTM). At the end of the double-blind phase, the two treatment groups will be compared with respect to their efficacy in controlling AD; at the end of the OL phase, the incidence of asthma at the age of 6 years will be compared.
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
- 3 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of atopic dermatitis
- •Family history of atopy
- •3 to 18 months of age at baseline
- •At least mild atopic dermatitis at baseline (investigator global assessment [IGA] greater or equal to 2)
- •Clinical evidence of atopic dermatitis for no longer than 3 months
排除标准
- •Diagnosis of or substantial clinical evidence for food or other allergies at baseline
- •Other protocol related criteria may apply
研究组 & 干预措施
1
Pimecrolimus
干预措施: Pimecrolimus (Drug)
2
Corticosteroid
干预措施: Corticosteroid (Drug)
结局指标
主要结局
Atopic Dermatitis (AD) Disease Control Over 36 Months
时间窗: 36 months
Proportion of disease-free days in Step 2 or less (per Patient) using total number of days in study as the denominator- double-blind phase. Intent to Treat Population: defined as all randomized patients who were dispensed study medication and had at least one post baseline efficacy measurement.
Effect of Early Use of Pimecrolimus Cream 1% in Reducing the Incidence of Asthma at 6 Years of Age
时间窗: 6 years
Note: The results for this efficacy variable are not reported due to early termination of the study.
次要结局
- Long Term Safety in Infants and Young Children(6 years)
- Incidence of Allergic Rhinitis, Allergic Conjunctivitis and Food Allergies(6 years (36 month Double-Blind Phase))
- Corticosteroid and Pimecrolimus Drug Use(48 months)
- Atopic Dermatitis (AD) Remission Time(36 month Double-Blind Phase)
- Patient/Caregiver Quality of Life(From Baseline to Visit 5 , 6, 8, 10, 12, and 14)