A prospective randomised, double-blind, placebo controlled trial on the effect of extended clofazimine on Erythema Nodosum Leprosum (ENL) in multibacillary (MB) leprosy

Objective: The objective of this study was to assess whether additional clofazimine could lower the incidence and/or severity of ENL reactions in leprosy. Methods: Multibacillary subjects, with a BI of over 4þ at any site, were recruited at the Cebu Skin Clinic. On completion of 12 months MB-MDT, which included clofazimine, subjects were randomised to receive either an additional 12 months of clofazimine (100 mg per day) or placebo, and were monitored during that period and for a further period of 12 months afterwards. Results: One hundred subjects were recruited, but only 25 developed ENL during the trial, which was far fewer than expected. On some measures, including deaths likely to be related to steroid intake, the placebo group appeared to have more severe ENL, but none of the differences were statistically significant. Conclusion: No beneficial preventive effect of clofazimine has been demonstrated in this small study. Any further study would require a larger sample size, but the target group could be narrowed to patients who have already had one episode of ENL. Clofazimine remains difficult to source outside its routine availability within MDT.