Leprosy
Conditions
Keywords
Leprosy, Type 1 Reactions, Prednisolone, Ciclosporin
Brief summary
Study 1A: Ciclosporin in the management of new Type 1 Reactions in Leprosy Objective: A randomised double blind controlled trial comparing Ciclosporin and Prednisolone,to determine whether treatment with Ciclosporin gives the same outcome in the treatment of new Type 1 Reactions as Prednisolone.
Detailed description
We tested our hypothesis that ciclosporin would be as effective as prednisolone in the treatment of patients with leprosy reactions and nerve function impairment and that patients treated with ciclosporin would have fewer side effects than patients treated with prednisolone. A randomised controlled trial comparing ciclosporin and prednisolone in the treatment of acute leprosy T1R was conducted.
Interventions
DRUGCiclosporin
Ciclosporin 7.5mg/kg - reducing regimen over 24 weeks (additional prednisolone given for the first four weeks)
DRUGPrednisolone
prednisolone 40mg daily then reducing regimen over 24 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 T1R with new nerve function impairment (NFI). * 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 |
|---|---|
| improvement in nerve function and Clinical Severity Score | at week 4, 20, 28 |
Secondary
| Measure | Time frame |
|---|---|
| Number of T1R recurrence episodes per patient in each treatment arm | up to 36 weeks |
| Severity of T1R recurrence for patients in each treatment arm | up to 36 weeks |
| Incidence of adverse events | up to 36 weeks |
| 6. Difference in score in Quality of Life assessment between start and end of treatment for patients in each treatment arm | 36 weeks |
| Mean time to recurrence of T1R for patients in each treatment arm | up to 36 weeks |
| extra prednisolone needed to control reaction | up to 36 weeks |
Countries
Ethiopia
Outcome results
None listed