Proactive Treatment With Tacrolimus Ointment in Children With Moderate/Severe Atopic Dermatitis: A Randomized, Multicenter, Open-label Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 125
- 主要终点
- Time to first DE (disease exacerbation)
研究概览
简要总结
To assess if proactive, 2 times-weekly application of tacrolimus ointment can extend remission time to relapse and reduce the incidence of disease exacerbation (DE) in paediatric patients over a period of 6 months.
详细描述
This study includes three periods. First a screening period of up to one week. Second an open-label treatment period of up to six weeks where all participants apply tacrolimus ointment. Third an open-label disease control period of up to six months where half of the participants apply tacrolimus ointment and the other half of the participants do not apply treatment.
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
- None
入排标准
- 年龄范围
- 2 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as AD according to Williams diagnostic criteria.
- •Moderate or severe atopic dermatitis according to the criteria of Rajka and Langeland
- •At least approximately 10 % of body area
- •Patient is able to reach the centre within 3 days in case of a disease exacerbation.
- •Patient's legal representative(s) has/have given written informed consent. If the patient is capable of understanding the purposes and risks of the trial, written informed consent has been obtained from the patient as well
排除标准
- 未提供
研究组 & 干预措施
continued tacrolimus treatment
children with moderate/severe atopic dermatitis treated with tacrolimus ointment and continuing to apply tacrolimus ointment during disease control period.
干预措施: tacrolimus (Drug)
结局指标
主要结局
Time to first DE (disease exacerbation)
时间窗: 6 months of DCP(Disease Control Period) after 2 to 6 weeks of OLP(Open Label Period)
次要结局
- The overall efficacy during OLP(After 2 to 6 weeks of OLP (Open Label Period))
- Investigator's Global Assessment (IGA)(6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period))
- Incidence of adverse events(6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period))
- Number of DEs during the DCP(6 months of DCP (Disease Control Period))
- Eczema Area and Severity Index (EASI)(6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period))
- Duration of DE during DCP(6 months of DCP (Disease Control Period))
- Quantity of tacrolimus ointment used(6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period))