NCT00475605终止不适用
APPLES: A Prospective Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Tacrolimus Ointment for the Treatment of Atopic Dermatitis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- LEO Pharma
- 入组人数
- 8,071
- 试验地点
- 301
- 主要终点
- Occurrence of systemic or cutaneous malignancy
研究概览
简要总结
This is an observational study to assess the long-term safety of Protopic® Ointment for the treatment of atopic dermatitis. Patients whose ages are/were < 16 years at the time of first tacrolimus ointment exposure are eligible to participate. No drug is distributed during this observational trial.
详细描述
Data will be collected at enrollment and every 6 months thereafter either by interview, Internet, or physician office visit. Each subject will be followed for 10 years in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who first used Protopic® 0.03% or 0.1% before they were sixteen years of age and were treated for at least 6 weeks for the treatment of Atopic dermatitis may enroll into the study.
排除标准
- 未提供
结局指标
主要结局
Occurrence of systemic or cutaneous malignancy
时间窗: 10 years
Standardised Incidence Ratio (versus population cancer rates)
次要结局
未报告次要终点
研究者
研究点 (301)
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