A Pilot (Double Blind Controlled) Study Randomizing Patients With New Acute ENL to Treatment Either With Ciclosporin or Prednisolone.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of ENL recurrence episodes per patient
研究概览
简要总结
Study 2A: Ciclosporin in the management of new Erythema Nodosum Leprosum
Objective: A pilot (double blind controlled) study randomizing patients to treatment either with Ciclosporin or Prednisolone to assess the safety, tolerability and efficacy of Ciclosporin in the treatment of patients with new acute Type 2 reactions (ENL).
详细描述
A pilot (double blind controlled) study randomizing patients to treatment either with Ciclosporin or Prednisolone to assess the safety, tolerability and efficacy of Ciclosporin in the treatment of patients with new acute Type 2 reactions (ENL).
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Individuals with clinical evidence of new ENL
- •Aged 18-65
- •Weigh more than 30Kg
排除标准
- •Unwillingness to give informed consent
- •Patients with severe active infections such as tuberculosis
- •Pregnant or breastfeeding women (see Appendix II)
- •Those with renal failure, abnormal renal function, hypertensive
- •Patients taking thalidomide currently or within the last 3 months
- •Patients not willing to return for follow-up
- •Women of reproductive age not willing to use contraception for the duration of the study ( see Appendix II)
- •HIV positive patients
研究组 & 干预措施
prednisolone
standard course of prednisolone given in a reducing regimen over 16 weeks
干预措施: prednisolone (Drug)
Ciclosporin
ciclosporin reducing regimen lasting 16 weeks (additional prednisolone given for the first four weeks)
干预措施: Ciclosporin (Drug)
结局指标
主要结局
Number of ENL recurrence episodes per patient
时间窗: up to 32 weeks
次要结局
- Frequency of adverse events for patients in each treatment arm(up to 32 weeks)
- Difference in score in Quality of Life assessment between start and end for patients in each treatment arm(up to 32 weeks)
- Mean time to ENL recurrence after initial control(up to 32 weeks)
- Amount of additional prednisolone required by patients(up to 32 weeks)
研究者
Saba Lambert
Clinical Research Fellow
London School of Hygiene and Tropical Medicine