NCT00445081已完成4 期
Prednisolone vs. Ciclosporine in Severe Atopic Eczema
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 5
- 主要终点
- stable remission in both treatment groups
研究概览
简要总结
To investigate the comparative efficacy of Ciclosporine A and Prednisolone in adult patients with severe atopic dermatitis.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and female patients age >= 18 and < 55
- •weight between 50 and 100 kg
- •confirmed diagnosis of AE (UK working party criteria)
- •objective SCORAD > 40
- •DLQI > 10
- •resistancy against topical treatment options including steroids and calcineurin-inhibitors
排除标准
- •participation to another clinical trial within the last 4 weeks before baseline
- •pregnant or breastfeeding
- •women of childbearing potential without adequate contraception
- •allergy against prednisolone or Ciclosporine A
- •acute bacterial or viral infection
- •malignant tumor in personal history
- •diabetes mellitus
- •arterial hypertension
- •peptic ulcer
- •severe osteoporosis
- •tuberculosis in personal history
- •colitis ulcerosa
- •diverticulitis
- •concurrent treatment with chloroquin, Mefloquin, Statins, Warafin
- •Creatinin Clearance < 60 ml /min
- •UV treatment within 8 weeks before inclusion
- •ongoing systemic immunosuppressive treatment
- •planned vaccination within 8 weeks before study entry, during study and 2 weeks after end of study
- •Poliomyelitis
- •Lymphadenitis after BCG vaccination
- •Hyperuricaemia
- •chronic liver disease
- •Xeroderma pigmentosum, Cockaye-Syndrome, Bloom Syndrome
- •Psychiatric co-morbidity
- •drug or alcohol abuse
研究组 & 干预措施
1
Active Comparator
干预措施: Prednisolone (Drug)
2
Active Comparator
干预措施: Ciclosporine A (Drug)
结局指标
主要结局
stable remission in both treatment groups
次要结局
- response rate in both treatment groups
- relapse rate in both treatment groups
- mean change in objective SCORAD in both treatment groups
- mean change in HRQL (DLQI) in both treatment groups
- change in disease symptoms (POEM)in both treatment groups
- Cost-effectiveness of both treatments
- Tolerability and Safety
- change in presenteeism in both treatment groups
- patient satisfaction
研究者
研究点 (5)
Loading locations...
相似试验
进行中（未招募）
不适用
Prednisolone vs. Ciclosporine in Severe Atopic Eczema. PROVE - Study - PROVEatopic eczemaMedDRA version: 8.1Level: LLTClassification code 10003641Term: Atopic eczemaEUCTR2006-003667-31-ATMedical Faculty, TU Dresden66
进行中（未招募）
不适用
Prednisolone vs. Ciclosporine in Severe Atopic Eczema. PROVE - Study - PROVEatopic eczemaMedDRA version: 8.1Level: LLTClassification code 10003641Term: Atopic eczemaEUCTR2006-003667-31-DEMedical Faculty, TU Dresden66
终止
4 期
Ciclosporin Versus Alitretinoin for Severe Atopic Hand Dermatitis.Atopic DermatitisNCT01231854Technische Universität Dresden15
进行中（未招募）
不适用
Ciclosporin vs. Alitretinoin for severe atopic hand dermatitis. A randomized controlled investigator-initiated double-blind trial. - TocyChronic atopic hand dermatitis, not responding to potent topical corticosteroids.EUCTR2009-017520-88-DEMedical Faculty, TU Dresden78
Unknown
不适用
Observation Study of Prednisone and Cyclosporine in Treatment of Thrombocytopenia in Hepatitis B CirrhosisHepatitis BCirrhosisThrombocytopeniaNCT01987791Peking University People's Hospital15