Ciclosporine and Extracorporal Photopheresis (ECP) Are Equipotent in Treating Severe Atopic Dermatitis (AD): A Randomized Cross-over Study Comparing Two Efficient Treatment Modalities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Change of SCORAD (SCORing Atopic Dermatitis)
研究概览
简要总结
Severe atopic dermatitis (AD) is a recurrent and debilitating disease often requiring systemic immunosuppressive treatment. The efficacy of cyclosporine A (CsA) is well proven but potential side effects are concerning. Several reports point at extracorporeal photopheresis (ECP) as an efficient alternative treatment modality with few and mild side effects. However, no direct comparison between CsA and ECP in the treatment of AD has been performed so far. In this trial we test the hypothesis that ECP is non-inferior to standard treatment with CsA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
入排标准
- 年龄范围
- 20 Years 至 45 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Criteria of inclusion were refractoriness to standard topical treatment (corticosteroid ointments, UVA, UVB, PUVA, tar).
排除标准
- •Criteria of exclusion were pregnancy, uncontrolled hypertension, previous malignancy, infectious disease, liver/kidney disease or active treatment with ECP or immunosuppressants within 4 weeks prior to start of trial.
研究组 & 干预措施
CsA-ECP
Sequence of therapy: First ciclosporin was given and after relapse extra corporal photopheresis was given
干预措施: Cyclosporine A (CsA) (Drug)
CsA-ECP
Sequence of therapy: First ciclosporin was given and after relapse extra corporal photopheresis was given
干预措施: Extracorporeal photopheresis (ECP) (Other)
ECP-CsA
Sequence of therapy: First extra corporal photopheresis was given and after relapse ciclosporin was given
干预措施: Cyclosporine A (CsA) (Drug)
ECP-CsA
Sequence of therapy: First extra corporal photopheresis was given and after relapse ciclosporin was given
干预措施: Extracorporeal photopheresis (ECP) (Other)
结局指标
主要结局
Change of SCORAD (SCORing Atopic Dermatitis)
时间窗: 4 month
次要结局
未报告次要终点
