drugset / Trial / NCT00233545

Miltefosine to Treat Cutaneous Leishmaniasis in Bolivia

NCT00233545

Phase 2 Completed 80 enrolled AB Foundation
RandomizedParallel-groupOpen-labelTreatment

Summary

Cutaneous leishmaniasis is typically treated with the parenteral product pentavalent antimony. Miltefosine is an oral agent shown to be active for mucosal leishmaniasis due to L braziliensis in Bolivia and cutaneous leishmaniasis due to L panamensis in Colombia. This trial is intended to evaluate miltefosine for cutaneous leishmaniasis due to L braziliensis in Bolivia. Patients will be randomly assigned to miltefosine or pentavalent antimony. Standard dose regimens will be used for both drugs.

Timeline

Start
2005-09
Primary completion
Completion
2007-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Miltefosine Small molecule Oral
Subject antimony Small molecule