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Combination of Topical Liposomal Amphotericin B and Glucantime in Comparison With Glucantime Alone for the Treatment of Anthroponotic Cutaneous Leishmaniasis (Acl) Caused by Leishmania Tropica: Study Protocol for a Randomized, Controlled Trial Publisher



Eskandari SE1 ; Khamesipour A1 ; Jaafari MR2 ; Javadi A3 ; Mohammadi AM1 ; Valian HK4 ; Nassirikashani M1 ; Goyonlo VM5, 6 ; Firooz A1
Authors
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Authors Affiliations
  1. 1. Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Tehran, Iran
  2. 2. Nanotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran
  3. 3. Department of Community Medicine, Qazvin University of Medical Sciences, Qazvin, Iran
  4. 4. Department of Medical Parasitology and Mycology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
  5. 5. Skin Diseases and Cutaneous Leishmaniasis Research Center, Mashhad University of Medical Sciences, Mashhad, Iran
  6. 6. Department of Dermatology, Emam Reza Hospital, Mashhad University of Medical Sciences, Mashhad, Iran

Source: Iranian Journal of Microbiology Published:2021


Abstract

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. © 2021 The Authors. Published by Tehran University of Medical Sciences.
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