NCT00523952已完成3 期
A 12-week, Exploratory, Non-comparative, Multi-centre Study to Evaluate the Efficacy and Safety of 0.1% Tacrolimus Ointment Administered in Adults With Moderate to Severe Atopic Dermatitis
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
- 303
- 主要终点
- Rate of patients with at least 50% (i.e. at least moderate) improvement according to the Physician's global evaluation of clinical response between Baseline and the Week 12/End of Study Visit
研究概览
简要总结
Objective: Assess efficacy and safety of tacrolimus ointment when used in adults with moderate or severe atopic dermatitis. The ointment was applied on the affected skin twice daily for 3 weeks and then once daily until all lesions were cleared
详细描述
The study was a one arm non-comparative study. The only study medication was Tacrolimus ointment 0.1% (Protopic ® 0.1%).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, any ethnic group, age ≥16
- •Moderate to severe atopic dermatitis
- •Has given informed consent
排除标准
- •Erythroderma
- •Pregnant or breast-feeding
- •Skin infection on the affected area
研究组 & 干预措施
1
Experimental
干预措施: tacrolimus ointment (Drug)
结局指标
主要结局
Rate of patients with at least 50% (i.e. at least moderate) improvement according to the Physician's global evaluation of clinical response between Baseline and the Week 12/End of Study Visit
时间窗: 12 weeks
次要结局
- Affected body surface area(12 weeks)
- Patient's assessment of global response(12 weeks)
- Physician's evaluation of clinical response(12 weeks)
- Changes of mEASI(12 weeks)
- Incidence of adverse events during the study, including all clinically significant laboratory values(12 weeks)
- Quality of Life at Baseline/Day 1 and Week 12/End of study(12 weeks)
研究者
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