Harmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network with capacities for clinical evaluation

by Olliaro P, Boni M, Carvalho EM, Chebli H, Cisse M, Diro E, Fernandes Cota G, Erber AC, Gadisa E, Handjani F, Khamesipour A, Llanos-Cuentas A, López Carvajal L, Grout L, Lmimouni BE, Mokni M, Nahzat MS, Ben Salah A, Ozbel Y, Pascale JM, Rizzo Molina N, Rode J, Romero G, Ruiz-Postigo JA, Gore Saravia N, Soto J, Uzun S, Mashayekhi V, Vélez ID, Vogt F, Zerpa O, Arana B. PLoS Neglected Tropical Diseases 2018, 12(1): e0006141, doi: 10.1371/journal.pntd.0006141.

Summary: Cutaneous leishmaniasis (CL) includes a range of skin conditions found across several continents. While not life-threatening, CL can be invalidating and disfiguring, or become complicated. There is no safe and effective treatment for CL and there has been no investment in drug development. Despite trying many treatments, clinical researchers have made little progress, and a lack of standardized methodologies for conducting trials hampers the collation and comparison of results. This paper summarizes the principles and parameters agreed upon by researchers in two separate meetings of how to identify patients and how to measure treatment effects in a way that will make it possible to gather convincing evidence of whether a treatment works or not. Adhering to these principles will allow faster progress towards offering better care to patients with this neglected disease.

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