Objective:

This study aims to perform a comparison of the efficacy and potential adverse effects associated with the use of Miltefosine and Glucantime for the treatment of cutaneous leishmaniasis (CL) in children. Method: A systematic review of clinical trials and cohort studies evaluating treatments for CL in children (≤12 years) was conducted. Structured searches were performed in PubMed, EMBASE, Cochrane, LILACS, Web of Science, and SciELO. No restrictions were applied regarding ethnicity, country, gender, or year of publication. Languages were limited to English, Spanish, and Portuguese. Two independent reviewers screened articles, extracted data, and assessed the risk of bias. A quantitative summary of included studies was performed. Results: A total of 747 records were found, including 3 randomized clinical trials (RCTs) and 1 non-randomized study. Most articles excluded in the full-text review did not report results separately for children. In American CL (ACL), 4 studies evaluated Miltefosine and Glucantime. Their efficacy ranged from 55.8 to 82.7 % and from 55 to 68.9 %, respectively. Conclusions: In this systematic review and meta-analysis, we found that Miltefosine is a better systemic treatment option for CL in terms of clinical cure and fewer adverse effects compared to Glucantime administered systemically; however, these differences were not significant.