CompletedPhase 2

Ciclosporin in the Management of New Erythema Nodosum Leprosum

Ethiopia12 participantsStarted 2010-07

Plain-language 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 to assess the safety, tolerability and efficacy of Ciclosporin in the treatment of patients with new acute Type 2 reactions (ENL).

Who can participate

Age range18 Years – 65 Years

SexFEMALE

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 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

What they're measuring

Number of ENL recurrence episodes per patient

Timeframe: up to 32 weeks

Trial details

NCT IDNCT00919542

SponsorLondon School of Hygiene and Tropical Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-12

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