Ciclosporin in the Management of Chronic or Recurrent Erythema Nodosum Leprosum
- Registration Number
- NCT00919776
- Lead Sponsor
- London School of Hygiene and Tropical Medicine
- Brief Summary
Study 2B: Ciclosporin in the management of chronic or recurrent Erythema Nodosum Leprosum Aim: To assess the safety, tolerability and efficacy of Ciclosporin in the treatment of patients whose ENL is not controlled with standard Prednisolone.
Objective: A pilot double blind controlled study randomizing patients whose ENL is not controlled with standard Prednisolone, and comparing a group treated with Ciclosporin to a group treated with additional steroid only.
- Detailed Description
A pilot double blind controlled study randomizing patients whose ENL is not controlled with standard Prednisolone, and comparing a group treated with Ciclosporin to a group treated with additional steroid only.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- Individuals with clinical evidence of recurrent or chronic ENL
- Aged 18-65
- Weigh more than 30Kg
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ciclosporin ciclosporin ciclosporin reducing regimen lasting 16 weeks (additional prednisolone given for the first four weeks) Prednisolone prednisolone standard course of prednisolone given in a reducing regimen over 16 weeks
- Primary Outcome Measures
Name Time Method number of ENL recurrence episodes per patient up to 32 weeks
- Secondary Outcome Measures
Name Time Method Frequency of adverse events for patients in each treatment arm up to 32 weeks Amount of additional prednisolone required by patients up to 32 weeks Severity of ENL at recurrence up to 32 weeks Mean time to ENL recurrence after initial control 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
Trial Locations
- Locations (1)
Alert Hospital
🇪🇹Addis Abeba, Ethiopia