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

by López L, Alvarez F, Ramos AP, Llanos-Cuentas A, Echevarria J, Vélez I, Boni M, Rode J, Quintero J, Jiménez A, Tabares Y, Méndez C, Arana B. PLOS Neglected Tropical Diseases 2022; 16(3):e0010238. doi: 10.1371/journal.pntd.0010238

Summary: For more than 70 years, pentavalent antimonials have been the first line treatment for cutaneous leishmaniasis, despite their toxicity, varying efficacy and need for administration of painful injections for 20 days or more. Effective, safe, low-cost treatment alternatives with non-invasive routes of administration are urgently needed. The authors report results of a clinical trial to evaluate the efficacy and safety of a thermotherapy plus short course of miltefosine combination compared with thermotherapy alone for the treatment of uncomplicated cutaneous leishmaniasis in Colombia and Peru. The combined therapy was significantly better than the monotherapy, with cure at 3 months’ follow-up achieved in 80.3% (n = 53) and 57.8% (n = 37) of patients in the intention to treat analysis, respectively.

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