Tehran University of Medical Sciences Iranian Journal of Microbiology 2008-3289 13 5 2021 10 08 718 723 EN Seyed Ebrahim Eskandari Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Tehran, Iran Ali Khamesipour Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Tehran, Iran Mahmoud Reza Jaafari Nanotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran Amir Javadi Department of Community Medicine, Qazvin University of Medical Sciences, Qazvin, Iran Akram Miramin Mohammadi Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Tehran, Iran Hossein Keshavarz Valian Department of Medical Parasitology and Mycology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran Mansour Nassiri-Kashani Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Tehran, Iran Vahid Mashayekhi Goyonlo Skin Diseases and Cutaneous Leishmaniasis Research Center, Mashhad University of Medical Sciences, Mashhad, Iran; Department of Dermatology, Emam Reza Hospital, Mashhad University of Medical Sciences, Mashhad, Iran Alireza Firooz Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Tehran, Iran 2021 01 02 2021 09 24 Background and Objectives: Cutaneous leishmaniasis (CL) treatment is a challenging issue, although numerous modalities have been introduced as candidate treatment for CL yet only antimonial agents are commonly used to treat CL, a different form of amphotericin B is used to treat visceral form of leishmaniasis but the efficacy against CL is not high. There are a few reliable clinical trials on CL, the main reason is the nature of the disease which required a well design protocol to evaluate the efficacy of any candidate treatment against CL. In this study, a protocol was developed and used to evaluate a topical formulation of a nano-liposomal form of amphotericin B in addition to glucantime to treat CL caused by L. tropica. Materials and Methods: This study is a phase 3, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of topical nano-liposomal amphotericin B (SinaAmpholeish 0.4%) in combination with intralesional injections of meglumine antimoniate in the treatment of ACL caused by L. tropica. Overall, 130 patients, aged 12-60 years, with a diagnosis of ACL caused by L. tropica are recruited and treated according to the protocol. Results: A total of 130 patients with CL lesion will be recruited and double- blind randomly treated with received intralesional injections of Glucantime weekly or Glucantime plus SinaAmpholeish for 4 weeks. Conclusion: The results of this study showed that the protocol works well and the treatment was tolerated by both groups of patients. https://ijm.tums.ac.ir/index.php/ijm/article/view/2916 https://ijm.tums.ac.ir/index.php/ijm/article/download/2916/1397