drugset / Trial / NCT04515186

Combination, Miltefosine Monotherapy for Cutaneous Leishmaniasis in New World

NCT04515186

Phase 3 Completed 184 enrolled Drugs for Neglected Diseases
RandomizedParallel-groupSingle-blindTreatment

Summary

This study evaluates if the combination of thermotherapy (one application, 50⁰C for 30") and 3 weeks of miltefosine is safe and have a comparable cure rate with the current recommended first line treatments comprising meglumine antimoniate for 3 weeks for the treatment of uncomplicated cutaneous leishmaniasis cases in the New World.

Timeline

Start
2021-01-26
Primary completion
2023-11-10
Completion
2024-02-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Meglumine antimonate Other / unclassified 20 mg/kg Other
Subject Miltefosine Small molecule 2.5 mg/kg Oral