Ciclosporin in the Management of Steroid Resistant Type 1 Reactions in Leprosy
- Registration Number
- NCT00919451
- Lead Sponsor
- London School of Hygiene and Tropical Medicine
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ciclosporin ciclosporin ciclosporin reducing regimen lasting 24 weeks (additional prednisolone given for the first four weeks)
- Primary Outcome Measures
Name Time Method improvement in nerve function at 24 weeks and 32 weeks
- Secondary Outcome Measures
Name Time Method incidence of adverse effects throughout 32 weeks Skin lesion inflammation improvement up to 36 weeks extra prednisolone needed to control reaction up to 36 weeks rate of improvement of reaction up to 36 weeks Time to next reactional episode up to 2 years
Trial Locations
- Locations (1)
Alert Hospital
🇪🇹Addis Abeba, Ethiopia