Thermotherapy + a Short Course of Miltefosine for the Treatment of Uncomplicated Cutaneous Leishmaniasis in the New World¨

Summary

The purpose of this trial is to determine the efficacy and safety of a combined therapy using thermotherapy (TT) (one session, 50 degrees Celsius for 30") + miltefosine at a standard dose of 2.5 mg/kg/day for 21 days for the treatment of uncomplicated CL in Peru and Colombia

Timeline

Start

2016-12

Primary completion

2019-08-10

Completion

2019-09-10

Outcome

Met primary endpoint

paper The TT + MLT regimen was better that TT alone (p = 0.0055). PMID 35255096 ↗

Publications

• Lopez L, Valencia B, Alvarez F, Ramos AP, Llanos-Cuentas A, Echevarria J, Velez I, Boni M, Rode J, Quintero J, Jimenez A, Tabares Y, Mendez C, Arana B. A phase II multicenter randomized study to evaluate the safety and efficacy of combining thermotherapy and a short course of miltefosine for the treatment of uncomplicated cutaneous leishmaniasis in the New World. PLoS Negl Trop Dis. 2022 Mar 7;16(3):e0010238. doi: 10.1371/journal.pntd.0010238. eCollection 2022 Mar.

Drugs

Indications