Ciclosporin in the Management of New Erythema Nodosum Leprosum

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

Official Title
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A Pilot (Double Blind Controlled) Study Randomizing Patients With New Acute ENL to Treatment Either With Ciclosporin or Prednisolone.

Conditions
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Leprosy

Intervention / Treatment
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* Drug: Ciclosporin
* Drug: prednisolone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: prednisolone<br>standard course of prednisolone given in a reducing regimen over 16 weeks | Drug: prednisolone<br>* prednisolone 40mg daily then reducing regimen over 16 weeks<br>* Other names: corticosteroids;|
| Experimental: Ciclosporin<br>ciclosporin reducing regimen lasting 16 weeks (additional prednisolone given for the first four weeks) | Drug: Ciclosporin<br>* Ciclosporin 7.5mg/kg - reducing regimen over 16 weeks (additional prednisolone given for the first four weeks)<br>* Other names: Cyclosporin A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of ENL recurrence episodes per patient |  | up to 32 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean time to ENL recurrence after initial control |  | up to 32 weeks | 
| Amount of additional prednisolone required by patients |  | up to 32 weeks | 
| Frequency of adverse events for patients in each treatment arm |  | up to 32 weeks | 
| Difference in score in Quality of Life assessment between start and end for patients in each treatment arm |  | up to 32 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leprosy, ENL, Erythema Nodosum Leprosum, Prednisolone, Ciclosporin