Ciclosporin in the Management of Chronic or Recurrent Erythema Nodosum Leprosum

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2013-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Leprosy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ciclosporin

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

Group Type EXPERIMENTAL

ciclosporin

Intervention Type DRUG

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

Prednisolone

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

Group Type ACTIVE_COMPARATOR

prednisolone

Intervention Type DRUG

prednisolone 40mg daily then reducing regimen over 16 weeks

Interventions

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prednisolone

prednisolone 40mg daily then reducing regimen over 16 weeks

Intervention Type DRUG

ciclosporin

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

Intervention Type DRUG

Other Intervention Names

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corticosteroids Cyclosporine Cyclosporin A

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No