Standards for cutaneous leishmaniasis clinical trials published

Quality methods documented

TDR news item
25 March 2013

Better standards for how to conduct clinical drug trials for cutaneous leishmaniasis (CL) should provide more solid evidence to improve drug treatment regimens. CL is the most common form of leishmaniasis, causing a range of skin lesions that may leave life-long scars. The WHO and TDR-led team of researchers identified the basic criteria and standards for any CL drug trial.

An estimated 700 000 to 1.2 million cases of cutaneous leishmaniasis occur worldwide each year, mostly in the Americas, the Mediterranean basin, and the Middle East and Central Asia. The type and severity of lesions, the Leishmania species involved, and the response to treatment vary considerably. Several clinical trials have been conducted on a variety of treatments, but it is difficult to understand which treatments work best in which situations, because the methodologies that have been used are not uniform. This document identifies standardized methodologies for conducting clinical trials, taking into account the complexity of the disease. It should help researchers conduct CL clinical drug trials so they are comparable and provide the highest level of quality results.

TDR is expanding support to assess the effectiveness of drug treatments for infectious diseases of poverty. The standards are also part of TDR’s research capacity building, where researchers from low- and middle-income countries are funded to conduct research while learning standards and processes.

For more information, please contact

Piero Olliaro