Leprosy
Conditions
Keywords
Leprosy, ENL, Erythema Nodosum Leprosum, Prednisolone, Ciclosporin
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.
Interventions
DRUGprednisolone
prednisolone 40mg daily then reducing regimen over 16 weeks
DRUGciclosporin
Ciclosporin 7.5mg/kg - reducing regimen over 16 weeks (additional prednisolone given for the first four weeks)
Sponsors
Homes and Hospitals of St Giles
Alert Hospital, Ethiopia
Armauer Hansen Research Institute, Ethiopia
London School of Hygiene and Tropical Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of ENL recurrence episodes per patient | up to 32 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Mean time to ENL recurrence after initial control | up to 32 weeks |
| Severity of ENL at recurrence | up to 32 weeks |
| Amount of additional prednisolone required by patients | up to 32 weeks |
| 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 |
Countries
Ethiopia
Outcome results
None listed