- Target disease: Cutaneous Leishmaniasis (CL)
- Main partners (since project start): Programa de Estudio y Control de Enfermedades Tropicales, Universidad de Antioquia, Medellin, Colombia and Universidad Peruana Cayetano Heredia, Lima, Peru; Thermosurgery Technologies Inc, USA; Programa Nacional de Leishmaniasis, Colombia.
- Project Start: June 2015
- Funding (since project start): Department for International Development (DFID), UK; Médecins Sans Frontières/Doctors without Borders.
When administrated alone, the safety and efficacy profiles of current CL treatments (antimonials, miltefosine, and thermotherapy) are well established. Using a combination of therapeutic approaches may improve efficacy rates, reduce treatment duration, and improve the rate of adverse events. A combination of one single application of thermotherapy at 50°C for 30 seconds with a three-week course of oral miltefosine will be tested in order to gain information about safety and efficacy.
Recruitment of patients continued in Peru with the inclusion of 41 patients, and started in Colombia with the inclusion of 21 patients (out of 130 patients in total). An interim analysis is planned in early 2018 once 65 patients have completed the day 90 follow-up visit.
At the end of 2016, official approvals were obtained, a site initiation visit conducted and the first patients were enrolled in Peru, while final approvals are expected by early 2017 for a second site in Colombia.
Last update: March 2018