Erythema nodosum leprosum (ENL) is a severe and extremely painful complication of leprosy which can occur before, during or after completion of antibacterial treatment. Current treatments are not as effective as we would like and have severe side effects.
This double-blinded randomised controlled study tests whether methotrexate is effective in ENL by comparing it with prednisolone (the corticosteroid most commonly used to treat ENL). At the end of the study the two groups of patients will be compared to see which have had the best response as measured against pre-determined outcomes. The participants in the study are drawn from Bangladesh, Brazil, Ethiopia, India, Indonesia, Nepal and the Philippines from centres who together form the ENL International STudy Group which is coordinated from the London School of Hygiene and Tropical Medicine. The Leprosy Mission centres in Bangladesh, India and Nepal are involved.
The study is funded by the Leprosy Research Initiative
This Leprosy Research Initiative funded randomised controlled study tests the effectiveness of additional Clofazimine in reducing the incidence and severity of ENL in Bangladesh (The Leprosy Mission International - Bangladesh) and India (Bombay Leprosy Project).
The control group (with ENL reaction) will receive extra doses of Clofazimine for 6 to 12 months, while the intervention group (with ENL reaction) will be given placebo vitamin tablets. Both groups will also receive standard treatment with steroids, the same as given to people who are not in the trial.
