Chemotherapy trial in paucibacillary leprosy using clofazimine.

In a double blind study, 300 PB patients (smear negative, indeterminate, tuberculoid and borderline tuberculoid) were randomly allotted to two regimens, the control subjects (150 patients) receiving the standard WHO multidrug regimen of six doses of once a month rifampicin with daily dapsone therapy for six months, while the study group (150 patients) receiving 50 mg of clofazimine daily for six months in addition to the WHO regimen. After stoppage of therapy all the patients were followed up on placebo. The regimens were well tolerated. In 7.5% of patients on clofazimine containing regimen, the lesions showed persisting activity at the time of stoppage of therapy, compared with 16% on the control regimen. This activity subsided spontaneously, more rapidly, in the study group (80% compared with 30% in the control group) in six months. Two patients in the control group and one patient in the study group developed late reaction. There were no relapses in the study group, whereas, two patients have relapsed in the control group during a follow-up of 2.5 to 3.5 years.