The Safety and Efficacy of an Immunomodulator Garlic‐Based Cream (LeishG1) for Treating Uncomplicated Cutaneous Leishmaniasis: A Single‐Blind, Multi‐Center Study

Background and Aims Cutaneous leishmaniasis (CL) is a major problem in developing nations, particularly in the Middle East. Novel herbal treatment options may provide a safe alternative associated with favorable outcomes in CL lesion healing. Here, we report the findings of a clinical study evaluating the safety and efficacy of an immunomodulator garlic‐based cream (LeishG1) for treating uncomplicated CL. Methods Volunteers diagnosed with CL were randomly assigned to either apply LeishG1 cream twice daily for 2 months ( n = 30) or receive a weekly intralesional injection of Glucantime® ( n = 30). Furthermore, to evaluate safety in healthy volunteers, LeishG1 cream was applied to the forearm two times daily for 2 weeks ( n = 25). The data was analysed using IBM SPSS software, version 24, and the efficacy of each treatment was determined using intention‐to‐treat (ITT) and per‐protocol (PP) analyses. Results The current study enrolled 60 CL patients, of whom 27 subjects with 30 lesions and 20 subjects with 27 lesions completed treatment courses with LeishG1 or Glucantime®, respectively. A complete cure at 2 months' follow‐up was observed in 56% ( n = 14 lesions) of the LeishG1 group and 65.4% ( n = 17 lesions) of the Glucantime® group in the PP analysis. Conclusion According to both the ITT and PP analyses, there was no significant difference in cure rate between the Glucantime® and LeishG1 groups. Regarding safety, LeishG1 raised no considerable safety concern, neither in CL patients nor in healthy volunteers. These findings suggest that LeishG1 cream is a safe and effective treatment option for CL. Registered in Iranian Registry of Clinical Trials (IRCTID: IRCT20180115038383N1) ( https://irct.behdasht.gov.ir/trial/29057 ).