Leprosy | Ciclosporin in the Management of Chronic or Recurrent Erythema Nodosum Leprosum
Leprosy research study
What is the primary objective of this study?
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 not controlled with standard Prednisolone. Objective: 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 steroid only.
Who is eligible to participate?
Inclusion Criteria: - Individuals with clinical evidence of recurrent or chronic 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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:prednisoloneprednisolone 40mg daily then reducing regimen over 16 weeks
Drug:ciclosporinCiclosporin 7.5mg/kg - reducing regimen over 16 weeks (additional prednisolone given for the first four weeks)
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
ciclosporinciclosporin reducing regimen lasting 16 weeks (additional prednisolone given for the first four weeks)
Prednisolonestandard course of prednisolone given in a reducing regimen over 16 weeks
Start Date: August 2010
Completed Date: July 2013
Phase: Phase 2
Primary Outcome: number of ENL recurrence episodes per patient
Secondary Outcome: Mean time to ENL recurrence after initial control
Study sponsors, principal investigator, and references
Principal Investigator: Diana NJ Lockwood, MBChB
Lead Sponsor: London School of Hygiene and Tropical Medicine
Collaborator: Homes and Hospitals of St Giles