Status:
COMPLETED
Ciclosporin in the Management of Chronic or Recurrent Erythema Nodosum Leprosum
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborating Sponsors:
Homes and Hospitals of St Giles
Alert Hospital, Ethiopia
Conditions:
Leprosy
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 ...
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 ste...
Eligibility Criteria
Inclusion
- Individuals with clinical evidence of recurrent or chronic ENL
- Aged 18-65
- Weigh more than 30Kg
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00919776
Start Date
August 1 2010
End Date
July 1 2013
Last Update
March 26 2015
Active Locations (1)
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1
Alert Hospital
Addis Ababa, Ethiopia