Clofazimine in lepra (ENL) reaction, one year clinical trial.

Twenty patients of lepromatous leprosy with lepra reaction and suspected dapsone resistance were treated with tapering doses of clofazimine. Clinical assessment was carried out every week. Bacteriological examination was carried out every six month. Fifteen patients became reaction free at the end of three months and severity and frequency of reactions was reduced in other patients. Nerve tenderness, arthralgia, nodular eruptions and all other signs and symptoms except anaesthesia showed complete recovery in fifteen patients and severity of the reactions was reduced in others. Gynaecomastia regressed in two out of three patients within nine months. In a majority of patients, the BI and MI was reduced at the end of 3 months, and further reduced after 6 months, and in one case both BI and MI became negative. Clinical and bacteriological improvement is attributed to the antibacterial effect of clofazimine while reduction in incidence of (ENL) reactions was attributed to anti-inflammatory effect of clofazimine. Regression of gynaecomastia may be due to either improvement of involvement of testes or liver or both. Apart from dyschromia clofazimine did not produce any severe side effects or toxicity.