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Spaced Clofazimine Therapy of Lepromatous Leprosy^*

Collaborative effort^, of the U. S. Leprosy Panel (U.S.-Japan Cooperative Medical Science Program) and the Leonard Wood Memorial

Patients with previously untreated borderline-lepromatous or fully lepromatous leprosy were treated with one of five clofazimine (B663) regimens: 1) 200 mg daily 6 days per week; 2) 100 mg three times weekly; 3) 300 mg weekly; 4) 600 mg every other week; and 5) 600 mg on 2 consecutive days every 4 weeks. After 24 weeks of treatment, the patients were randomly allocated to treatment either with 200 mg B663 daily 6 days per week (regimen 6) or with dapsone, beginning with a small dosage and increasing over a period of 8 weeks to 100 mg daily 6 days per week (regimen 7). Death of Mycobacterium leprae was monitored by mouse inoculation with organisms recovered from skin biopsy specimens obtained at intervals during the first 24 weeks. Killing of M. leprae proceeded most rapidly in regimen 1 and 2 patients, least rapidly in the patients of regimens 4 and 5, and at an intermediate rate in regimen 3 patients. Erythema nodosum leprosum (ENL) was no more frequent nor more severe during treatment with any one of the first-24-weeks regimens. ENL was more frequent in regimen 7 than in regimen 6 patients. Pigmentation of the skin, assessed only during the first 24 weeks, occurred in patients of all regimens, but was most marked in regimen 1 patients. No evidence of B663 toxicity was noted. Although all of the first-24-weeks regimens were effective in terms of the rate of killing of M. leprae, greater effectiveness was associated with more frequent administration of the drug. The B663 that accumulated in the tissues did not appear to be available to exert an antimicrobial effect.

Accepted for publication November 8, 1975.

^* Address reprint requests to Dr. Charles C. Shepard, Center for Disease Control, Atlanta, Georgia 30333.

A Chemotherapy Committee, whose members were drawn from the Panel and the staff of Leonard Wood Memorial (LWM), developed the protocol and supervised the conduct of the trial. Members of the Committee were C. H. Binford (LWM, Washington), R. S. Guinto (LWM, Cebu, The Philippines), L. Levy (Public Health Service Hospital, San Francisco), C. C. Shepard (Center for Disease Control, Atlanta), and J. G. Tolentino (LWM, Cebu). Other participants in the investigation included R. Abalos, E. C. dela Cruz, T. T. Fajardo, J. N. Rodriguez, and G. P. Walsh, all of LWM, Cebu. The trial was carried out at the LWM facilities at the Eversley Childs Sanitarium, Cebu, with the assistance of A. P. Perez, Director of the Sanitarium, and of the Government of the Philippines. The trial was supported by a contract between the National Institute of Allergy and Infectious Diseases (National Institutes of Health) and LWM.