It is a randomized phase II clinical study, unicentre aimed to evaluate the tolerability, safety and efficacy of 18-Methoxyoronaridine as a candidate of tegumentary leishmaniasis treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Drug under evaluation for leishmaniasis treatment
Leishmaniasis standard drug in Brazil
Lesion Reduction and Re-epithelization - Definitive Cure
complete epithelization of all ulcers and complete disappearance of inflammatory hardening of all lesions at 6 months at the follow-up visit.
Time frame: 6 months at the follow-up visit.
Lesion Reduction and Re-epithelization - Partial Cure
incomplete epithelialization or incomplete regression of inflammatory hardening of one or more lesions, and without the appearance of new lesions. Apparent cure: complete epithelization of all ulcers and regression ≥ 70% of the inflammatory hardening of all lesions.
Time frame: 6 months at the follow-up visit.
Clinical Failure
Any of the following topics as clinical failure: residual readers with the presence of non-GiemsaDiff-Quick print parasites, or the appearance of new lesions or ≥ 20% increase or no improvement of lesions previously documented.
Time frame: 6 months at the follow-up visit.
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