NCT01789619已完成不适用
Extended Release Tacrolimus (Advagraf®) in Severe Adult Atopic Dermatitis Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Change in Scoring Atopic Dermatitis (SCORAD)
研究概览
简要总结
To evaluate the clinical efficacy of the extended release formulation of tacrolimus (Advagraf®) in patients with severe atopic dermatitis, who can not be treated adequately with cyclosporine A because of side effects and/or non-responsiveness.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with severe atopic dermatitis, uncontrolled by topical treatment (indication for oral immunosuppressive drugs), who are unresponsive to Cyclosporin A, or in which treatment was discontinued because of side effects.
排除标准
- •Concomitant use of other oral immunosuppressive drugs and/or UV light therapy
- •Preexisting abnormalities in liver function, kidney function or haematological abnormalities
- •History of malignancy within the last 5 years
- •Uncontrolled hypertension
- •Pregnancy or lactation; wish for pregnancy during the treatment period
- •Infections requiring continued therapy
- •Known positivity for HIV
- •Evidence of drug and/or alcohol abuse
研究组 & 干预措施
Extended release tacrolimus (Advagraf®)
干预措施: Extended release tacrolimus (Advagraf®) (Drug)
结局指标
主要结局
Change in Scoring Atopic Dermatitis (SCORAD)
时间窗: Every 4 weeks up to one year
Clinical eczema scores
次要结局
- Change in Patient-Oriented Eczema Measure (POEM)(Every 4 weeks up to one year)
- Change in Thymus and Activation-Regulated Chemokine in serum (TARC)(Every 4 weeks up to one year)
研究者
研究点 (1)
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