Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: A Phase 2 Study in the Old World

Inclusion Criteria: * Age 5-75 years * Lesions must measure at least 1 cm and be primarily ulcerative * Have cutaneous leishmaniasis proven parasitologically in the lesion selected for study * Must have given written informed consent to participate in the study Exclusion Criteria: * Known drug intolerance to aminoglycosides in the patient or immediate family * Previous use of antileishmanial drugs (within 3 months) or present use of routinely nephrotoxic or ototoxic drugs * Patients with tuberculosis under treatment * Potential for follow-up: have less than 7 months time remaining in present address and/or plan to leave the area for more than 30 days * Extent of disease: more than 5 lesions or lesion equal to or greater than 5 cm or a lesion less than 5 cm from the eye, or a lesion in the face that, in the opinion of the attending dermatologist could potentially cause significant disfigurement * Location of disease: mucosal involvement * Disseminated disease: clinically significant lymphadenitis with nodules that are painful and greater than 1 cm in size in the lymphatic drainage of the ulcer * Concomitant medical problems: significant medical problems of the kidney or liver as determined by history and by the following laboratory studies: * Hearing abnormality * Ongoing pregnancy or have plans to become pregnant * Females of child bearing age (Tunisia Only) * Signs or symptoms of peripheral neuropathy Kidney: clinically significant abnormalities of urine analysis, serum …