Cutaneous Leishmaniasis
Conditions
Interventions
Experimental group: 110 patients with cutaneous leishmaniasis will receive itraconazole, 400mg/day, via oral intake, during 60 days.
Control group: 110 patients with cutaneous leishmaniasis will recei
Drug
D03.383.129.799.550
Sponsors
Fund. de Medicina Tropical Dr Heitor Vieira Dourado
Universidade do Estado do Amazonas
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patients with Ulcerated Cutaneous Leishmaniasis, not previously treated; diagnosed through at least one of the following tests: direct examinations of the lesion, biopsy of the lesion, culture or polimerase chain reactions (PCR) positives to Leishmania guyanensis; age of 18-65 years old; both genders; presenting at least 1 to 3 ulcerated lesions, in any localization; lesion diameter between 1-5 cm; clinical evolution not inferior to 1 month and not superior to 3 months.
Exclusion criteria
Exclusion criteria: Evidence of severe underlying disease (heart, kidney, liver, lung) or malignant disease; immunodeficient or HIV-infected patients; severe protein and / or caloric malnutrition; any active and uncontrolled infectious disease, such as tuberculosis, leprosy, systemic fungal disease (histoplasmosis, paracoccidioidomycosis); pregnant or nursing women; history of previous treatment for leishmaniasis; inability or willingness to provide informed consent (patient and / or / legal representative); lack of availability for visits or to comply with study procedures; patients participating in another ongoing clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Initial healing rate ;Clinical examination to evaluate the initial healing rate. Initial healing will be considered the complete epithelialization of the cutaneous lesions, in the absence of any inflammatory signs, 2 months after the drug treatment, by means visual clinical evaluation (physical medical exam). | — |
Secondary
| Measure | Time frame |
|---|---|
| Final healing rate;Clinical examination to evaluate the final healing rate. Final healing will be considered the complete epithelialization of the cutaneous lesions, in the absence of any inflammatory signs, 6 months after the drug treatment, by means of visual clinical evaluation (physical medical exam). | — |
Countries
Brazil
Contacts
Public ContactMelissa Cavalcante
Fund. de Medicina Tropical Dr Heitor Vieira Dourado
Outcome results
None listed