Effect of Additional Clofazimine on Erythema Nodosum Leprosum (ENL) Reactions 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 (Drug), also known as Lamprene: Clofazimine 100mg daily for 12 months after completion of MDT.
• Placebo (Drug), also known as Vitamin capsule: Daily for 12 months

Primary outcomes

• Incidence of ENL reactions [2 years of follow-up]: The hypothesis is that additional clofazimine will reduce the incidence of ENL reactions in the two years following completion of MDT.

Secondary outcomes

• Severity of ENL reactions [2 years of follow-up]: 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.

Sex: All, ages: 15 Years to 70 Years

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

• Marivic Balagon, MD, Principal investigator, LWM