Ciclosporin in the Management of Chronic or Recurrent Erythema Nodosum Leprosum

Phase 2CompletedNCT00919776

London School of Hygiene and Tropical Medicine20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Leprosy

Interventions

prednisoloneDRUG

prednisolone 40mg daily then reducing regimen over 16 weeks

ciclosporinDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Alert Hospital

Addis Ababa, Ethiopia

Outcomes

Primary Outcomes

number of ENL recurrence episodes per patient

Time frame: up to 32 weeks

Secondary Outcomes

Mean time to ENL recurrence after initial control

Time frame: up to 32 weeks

Severity of ENL at recurrence

Time frame: up to 32 weeks

Amount of additional prednisolone required by patients

Time frame: up to 32 weeks

Frequency of adverse events for patients in each treatment arm

Time frame: up to 32 weeks

Difference in score in Quality of Life assessment between start and end for patients in each treatment arm

Time frame: up to 32 weeks

Data from ClinicalTrials.gov

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