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Leprosy | Ciclosporin in the Management of New Erythema Nodosum Leprosum

Leprosy research study

What is the primary objective of this study?

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).

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Leprosy

Study Interventions

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:CiclosporinCiclosporin 7.5mg/kg - reducing regimen over 16 weeks (additional prednisolone given for the first four weeks)

Drug:prednisoloneprednisolone 40mg daily then reducing regimen over 16 weeks

Study Arms

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.

prednisolonestandard course of prednisolone given in a reducing regimen over 16 weeks

Ciclosporinciclosporin reducing regimen lasting 16 weeks (additional prednisolone given for the first four weeks)

Study Status

Completed

Start Date: July 2010

Completed Date: July 2013

Phase: Phase 2

Type: Interventional

Design:

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

More information:https://clinicaltrials.gov/show/NCT00919542

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