This study aims to assess the effectiveness of additional doses of Clofazimine in reducing frequency and severity of ENL.
Does additional clofazimine for MB cases at high risk of ENL improve their prognosis/outcome over 2 years?
Erythema nodosum leprosum (ENL) is an unpleasant complication of leprosy which can lead to considerable suffering, impaired quality of life, and long term disability. Clofazimine has long been used to reduce severity and recurrence of ENL, however, there is limited published evidence for its effectiveness.
This study intends to test the effectiveness of additional Clofazimine in reducing the incidence and severity of ENL. One group of patients who are suffering from ENL reactions will receive extra doses of Clofazimine for 6 to 12 months. The other group of patients suffering from ENL reactions will be given placebo vitamin tablets to compare the difference in well-being between the two groups. Both groups will also receive standard treatment with steroids, the same as given to people who are not in the trial.
Research question: Does 6- 12months additional administration of Clofazimine medicine to patients under the leprosy treatment or within 12 months of the completion of the treatment and once suffered from ENL reactions, reduce the frequency and severity of the reaction and its consequences in them and possibly have a beneficial effect on their nerve function during the observation period of 24 months.
The research group will assess the results in each group by using standard scales for ENL severity. This will also be done for quality of life as well as nerve damage, and the amount of steroid medication needed. The results will help doctors decide best treatments for ENL patients in future.
Co-financer: Turing Foundation