CompletedPhase 2

Ciclosporin in the Management of Chronic or Recurrent Erythema Nodosum Leprosum

Ethiopia20 participantsStarted 2010-08

Plain-language 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 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 can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

number of ENL recurrence episodes per patient

Timeframe: up to 32 weeks

Trial details

NCT IDNCT00919776

SponsorLondon School of Hygiene and Tropical Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-12

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