NCT00368719撤回4 期
APPLES: A Prospective Pediatric Longitudinal Evaluation To Assess The Long Term Safety Of Tacrolimus Ointment For The Treatment Of Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- The purpose of this study is to identify the long term effects of Tacrolimus in pediatric subjects
研究概览
简要总结
To assess the long-term safety of tacrolimus ointment
详细描述
To assess the long-term safety of tacrolimus ointment 0.03% or 0.1% in the treatment of subjects with atopic dermatitis under actual use conditions, including the risk of developing cutaneous or systemic malignancies. The FDA and EMEA approved Tacrolimus ointment, 0.03% in children and 0.1% and 0.03% in adults, for the treatment of atopic dermatitis. As part of the approval process, the FDA and EMEA requested a post-marketing commitment regarding the safety of long-term use of Tacrolimus ointment in pediatric atopic dermatitis subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject has/had atopic dermatitis.
- •Subject has applied tacrolimus ointment 0.03% or 0.1% for at least 6 weeks, continuously or intermittently. This may include subjects who have been enrolled in previous tacrolimus ointment studies and/or subjects with commercial product exposure prior to study enrollment.
- •Subject age at the first tacrolimus ointment exposure is/was <16 years of age.
- •Subject/Caregiver has given written informed consent and assent as required by state and/or governmental laws, including access to all relevant clinical and medication data, and the storage and analysis of these data.
- •Subject/Caregiver agrees to comply with the program requirements including an annual physical exam and biennial dermatological exam and agrees to be contacted and provide information as described in this document to Primary Investigator Dr. Lamb and Covance Periapproval Services, Inc.
排除标准
- •Subjects who do not have/ have not had Atopic Dermatitis.
- •Subjects must have used Tacrolimus ointment prior to age 16.
研究组 & 干预措施
1
No Intervention
干预措施: Tacrolimus (Drug)
结局指标
主要结局
The purpose of this study is to identify the long term effects of Tacrolimus in pediatric subjects
时间窗: 10 Years
次要结局
未报告次要终点
研究者
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