drugset / Trial / NCT04268524

Randomised Clinical Trial for New Treatment Modalities for Cutaneous Leishmaniasis Caused by Leishmania Tropica, in Pakistan

NCT04268524

Phase 3 Recruiting 832 enrolled Medecins Sans Frontieres, Netherlands
RandomizedParallel-groupOpen-labelTreatment

Summary

randomised control clinical trial to evaluate miltefosine, thermotherapy and the combination miltefosine-thermotherapy are effective, safe and tolerable alternative treatment options to treat cutaneous leishmaniasis caused by L. tropica, in Pakistan compared to the standard of care.

Timeline

Start
2022-10-07
Primary completion
2025-12-31
Completion
2026-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Miltefosine Small molecule 2.5 mg/kg Oral
Subject Miltefosine Small molecule 100 mg Oral
Subject Miltefosine Small molecule 150 mg Oral