NCT00568997进行中（未招募）不适用
A Prospective 10 Year Observational Registry of Pediatric Subjects (Age Greater Than or Equal to Two Years to Age Less Than or Equal to 17 Years) With Atopic Dermatitis Who Have Used Elidel Cream 1% (Pimecrolimus)
适应症
干预措施
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
- 8,000
- 试验地点
- 1
- 主要终点
- The incidence rate of systemic malignancies in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream
研究概览
简要总结
This study will examine the risk of systemic malignancies in pediatric patients with atopic dermatitis exposed to Elidel 1% cream.
详细描述
Registry study to examine the risk of systemic malignancies in pediatric patients with atopic dermatitis exposed to Elidel 1% cream.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •males and females
- •greater than or equal to 2 years and less than or equal to 17 years at enrollment
- •diagnosis of atopic dermatitis (confirmed by treating physician)
- •applied pimecrolimus cream 1 % 6 weeks out of past 24 weeks
排除标准
- •past or present history of systemic malignancy, skin malignancy, or lymphoproliferative disease
- •past or present use of oral immunosuppressive therapy
研究组 & 干预措施
1
Single-group Open Label Registry of patients exposed to Elidel/Pimecrolimus
干预措施: Pimecrolimus (Drug)
结局指标
主要结局
The incidence rate of systemic malignancies in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream
时间窗: 10 years of observation with 6-month reporting intervals
次要结局
- The incidence rate of thyroid cancer in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream(10 years of observation with 6-month reporting intervals)
- The incidence rate of lymphoma in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream(10 years of observation with 6-month reporting intervals)
- The incidence rate of cutaneous malignancy in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream(10 years of observation with 6-month reporting intervals)
研究者
研究点 (1)
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