Leprosy Clinical Trial
Official title:
A Pilot (Double Blind Controlled) Study Randomizing Patients With New Acute ENL to Treatment Either With Ciclosporin or Prednisolone.
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 to assess the safety, tolerability and efficacy of
Ciclosporin in the treatment of patients with new acute Type 2 reactions (ENL).
Status | Completed |
Enrollment | 12 |
Est. completion date | July 2013 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Individuals with clinical evidence of new ENL - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Ethiopia | Alert Hospital | Addis Abeba |
Lead Sponsor | Collaborator |
---|---|
London School of Hygiene and Tropical Medicine | Alert Hospital, Ethiopia, Armauer Hansen Research Institute, Ethiopia, Homes and Hospitals of St Giles |
Ethiopia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of ENL recurrence episodes per patient | up to 32 weeks | No | |
Secondary | Mean time to ENL recurrence after initial control | up to 32 weeks | No | |
Secondary | Amount of additional prednisolone required by patients | up to 32 weeks | No | |
Secondary | Frequency of adverse events for patients in each treatment arm | up to 32 weeks | No | |
Secondary | Difference in score in Quality of Life assessment between start and end for patients in each treatment arm | up to 32 weeks | No |
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