Leprosy
Conditions
Keywords
Leprosy, Type 1 Reaction, Prednisolone, Ciclosporin
Brief summary
Study 1B: Ciclosporin in the management of steroid resistant Type 1 Reactions in Leprosy Objective: A pilot study assessing the efficacy and safety of Ciclosporin as a second -line drug in patients with Type 1 Reactions who have not responded to a 12 week course of Prednisolone.
Interventions
DRUGciclosporin
Ciclosporin 7.5mg/kg - reducing regimen over 24 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
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Individuals with clinical evidence of Type 1 Reaction who have not responded to 3 months Prednisolone Treatment * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| improvement in nerve function | at 24 weeks and 32 weeks |
Secondary
| Measure | Time frame |
|---|---|
| incidence of adverse effects | throughout 32 weeks |
| Skin lesion inflammation improvement | up to 36 weeks |
| rate of improvement of reaction | up to 36 weeks |
| Time to next reactional episode | up to 2 years |
| extra prednisolone needed to control reaction | up to 36 weeks |
Countries
Ethiopia
Outcome results
None listed