Effect of Additional Clofazimine on Erythema Nodosum Leprosum (ENL) Reactions in Leprosy
Effect of Additional Clofazimine on ENL Reactions in Leprosy
Lead SponsorUnited States Army
StatusCompleted No Results Posted
Indication/ConditionBorderline Lepromatous Leprosy Lepromatous Leprosy
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.
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.
Clofazimine 100mg daily for 12 months after completion of MDT.
Daily for 12 months
These patients will receive placebo for 12 months after completion of MDT.
Patients will be given clofazimine (100mg daily) for 12 months after completion of MDT.
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