Status:
COMPLETED
Ciclosporin in the Management of New 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:
FEMALE
18-65 years
Phase:
PHASE2
Brief Summary
Study 2A: Ciclosporin in the management of new Erythema Nodosum Leprosum Objective: A pilot (double blind controlled) study randomizing patients to treatment either with Ciclosporin or Prednisolone t...
Detailed Description
A pilot (double blind controlled) study randomizing patients to treatment either with Ciclosporin or Prednisolone to assess the safety, tolerability and efficacy of Ciclosporin in the treatment of pat...
Eligibility Criteria
Inclusion
- Individuals with clinical evidence of new 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 :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00919542
Start Date
July 1 2010
End Date
July 1 2013
Last Update
March 24 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Alert Hospital
Addis Ababa, Ethiopia