Experiment for the treatment of Leishmaniasis of the skin with two drugs, Pentamidine and Tamoxifen

INTERVENTION: V03.175.250.500.500 D02.078.100.700 D02.455.426.559.389.150.700.900 Two‐arm randomized controlled clinical trial. Of 126 patients evaluated, a total of 50 people met the eligibility criteria and were probabilistically allocated to one or the other group using a computer‐generated table of random numbers. In the experimental group, 26 people with cutaneous leishmaniasis were allocated and received administration of Pentamidine at a dose of 7 mg per kg of weight in a single intramuscular dose, on the first day of treatment, followed by oral Tamoxifen at a dose of 20 mg ( one tablet) every 12 hours for twenty days. In the control group, 24 people with cutaneous leishmaniasis were allocated, who received intramuscular administration of pentamidine isothionate at a dose of 7 mg per kg per day, with an interval of seven days between each dose, totaling three doses in a period of 21 days. The treatment of one person in the experimental group was discontinued due to diagnostic error due to the direct test for leishmaniasis having given a false positive result, the study being concluded with 49 patients CONDITION: Capítulo I Cutaneous leishmaniasis PRIMARY OUTCOME: The primary outcome is clinical cure, defined as complete healing of all ulcers (with flattening of the edges, disappearance of the crust, scaling, infiltration or hardening of the base, erythema and lymphangitis or adenitis, if present, and absence of new lesions) in the 6th month after starting treatment. According to the time of evaluation, cases will be classified into: partial healing, that is incomplete healing of one or more lesions and absence of new lesions in the follow‐up, up to 3 months after the start of treatment; initial healing with complete epithelialization of all ulcers, up to 3 months after starting treatment; treatment failure, defined as failure to completely epithelialize the lesions within 6 months of treatment, or if the lesions worsen or if a new lesion appears at any time SECONDARY OUTCOME: Secondary outcomes are adverse effects characterized by the presence of signs or symptoms related to drug use, classified as: mild, if tolerated, without symptomatic drug interference or discontinuation of specific therapy; moderate, when tolerated with the use of symptomatic medication; severe, when it cannot be circumvented, except with the suspension of the specific medication INCLUSION CRITERIA: Aged from 18 to 65 years; diagnosis of Cutaneous Leishmaniasis confirmed by direct parasitological examination; with a maximum of si Xlesions; without previous treatment