NCT00480896已完成3 期
Clinical Study on Tacrolimus Ointment Over the Long-term. "CONTROL Study - Children"
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Number of exacerbations of atopic dermatitis requiring intervention.
研究概览
简要总结
A long-term 0.03% tacrolimus ointment based regimen comprising of up to 6 weeks of initial twice daily treatment and subsequent twice weekly prophylactic application can effectively treat active lesions of atopic dermatitis, and prevent, delay, and reduce flares.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female patient of any ethnic group
- •Patient was at least 2-15 years old and suffered from mild to severe atopic dermatitis (Rajka/Langeland score of at least 3)
排除标准
- •Patient had a genetic epidermal barrier defect such as Netherton's syndrome or generalised erythroderma
- •Patient had a clinically significant skin infection on the affected (and to be treated) area
研究组 & 干预措施
1
Experimental
干预措施: tacrolimus ointment (Drug)
2
Placebo Comparator
干预措施: Placebo ointment (Drug)
结局指标
主要结局
Number of exacerbations of atopic dermatitis requiring intervention.
时间窗: 12 months
次要结局
- Time to first exacerbation requiring intervention; exacerbation treatment days, periods and time to first exacerbation; physician and patient assessment of affected area, treatment response; quality of life; global response.(12 months)
研究者
研究点 (1)
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