Trial of Miltefosine in Cutaneous Leishmaniasis (Brazil)

Inclusion Criteria: * Newly diagnosed (untreated) cutaneous leishmaniasis with localized lesions and visualization of amastigotes in tissue samples or a positive culture or diagnosed by polymerase chain reaction (PCR) methods or by intradermal skin testing (Montenegro test). * Number of lesions: 1 to 5 ulcerative lesions. * Lesion´s diameter: 1 to 5 cm. * Disease duration: up to three months. Exclusion Criteria: Safety concerns: * Thrombocyte count \<30 x 109/l * Leukocyte count \<1 x 109/l * Hemoglobin \<5 g/100 ml * ASAT, ALAT, AP \>3 times upper limit of normal range * Bilirubin \>2 times upper limit of normal range * Serum creatinine or BUN \>1.5 times upper limit of normal range * Evidence of serious underlying disease (cardiac, renal, hepatic or pulmonary) * Immunodeficiency or antibody to HIV * Any non-compensated or uncontrolled condition, such as active tuberculosis, malignant disease, severe malaria, HIV, or other major infectious diseases * Lactation, pregnancy (to be determined by adequate test) or inadequate contraception in females of childbearing potential for treatment period plus 2 months Lack of suitability for the trial: * Negative parasitology (aspirate/smear)or negative Montenegro test * Any history of prior anti-leishmania therapy * Any condition which compromises ability to comply with the study procedures * Concomitant serious infection other than cutaneous Administrative reasons: * Lack of ability or willingness to give informed consent (patient and/or parent / legal representative) * Anticipated non-availability for study visits/procedures