Cutaneous leishmaniasis (CL) standard treatment is done with parenteral pentavalent antimony
(Sbv) at the dose of 15-20mg / kg per day for 20 days. However, therapeutic failure has been
described in up to 50% of patients, and the long period of 60 to 90 days required for healing
of the ulcerated lesion indicate the need for alternative drugs. Currently the alternatives
include other parenteral drugs such as pentamidine and amphotericin B, whose use is limited
either by toxicity or because, as with Sbv, the parenteral route hinders adherence and
regularity of treatment in the rural area. Recent studies by our group indicate that oral
miltefosine is the most effective drug for the treatment of patients with CL caused by L.
(V.) guyanensis and L. (V.) braziliensis in Brazil, with a cure rate of 71.4% and 75%
respectively. CL pathogenesis is associated with intense inflammatory infiltrate and tissue
damage. Previous trials associating GM-CSF to Sbv improved the cure rate of CL caused by L.
(V.) braziliensis. The objective of this trial is to evaluate the therapeutic response to the
use of miltefosine associated to GM-CSF in the treatment of CL caused by L. (V.) braziliensis
in an endemic region in Bahia and Ceará, and by L. (V.) guyanensis in the Amazon region.