Effect of Additional Clofazimine on Erythema Nodosum Leprosum (ENL) Reactions in Leprosy

Study Overview
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Brief Summary
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This study is a double-blind, randomized controlled trial examining the effect on ENL reactions of giving an additional year of clofazimine after completion of MDT in leprosy.

Detailed Description
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Clofazimine is an anti-bacterial agent used to treat leprosy; it is a normal component of WHO-recommended multi-drug therapy (MDT). It is also known to have a beneficial effect in one of the common immunological reactions that occur in leprosy, known as erythema nodosum leprosum, or ENL. When MDT was reduced in length from 24 to 12 months, evidence suggests that ENL became worse. This study is a double-blind, randomized controlled trial examining the effect of giving an additional year of clofazimine after completion of MDT. The endpoints are the incidence and severity of ENL over a period of 3 years in the 2 groups.

Official Title
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Effect of Additional Clofazimine on ENL Reactions in Leprosy

Conditions
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Borderline Lepromatous Leprosy, Lepromatous Leprosy

Intervention / Treatment
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* Drug: Clofazimine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 15 to 70 years of age MB leprosy Pretreatment BI of 4 or more at any site Consent Exclusion Criteria: Presence of another serious illness Refusal of informed consent

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo group<br>These patients will receive placebo for 12 months after completion of MDT. | Drug: Placebo<br>* Daily for 12 months<br>* Other names: Vitamin capsule;|
| Experimental: Clofazimine for 12 months after MDT<br>Patients will be given clofazimine (100mg daily) for 12 months after completion of MDT. | Drug: Clofazimine<br>* Clofazimine 100mg daily for 12 months after completion of MDT.<br>* Other names: Lamprene;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of ENL reactions | The hypothesis is that additional clofazimine will reduce the incidence of ENL reactions in the two years following completion of MDT. | 2 years of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of ENL reactions | The hypothesis is that additional clofazimine will reduce severity of ENL reactions, as well as incidence. Severity will be monitored by three indicators: 1. a rather crude clinical score (mild, moderate or severe), 2. the total dose of prednisolone given to treat ENL reactions, 3. the total duration of ENL symptoms. | 2 years of follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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leprosy, ENL, clofazimine