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).