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

Seyed Ebrahim Eskandari; Ali Khamesipour; Mahmoud Reza Jaafari; Amir Javadi; Akram Miramin Mohammadi; Hossein  Keshavarz Valian; Mansour Nassiri-Kashani; Vahid  Mashayekhi G oyonlo; Alireza Firooz

doi:10.18502/ijm.v13i5.7440

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 G oyonlo Skin Diseases and Cutaneous Leishmaniasis Research Center, 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

DOI: https://doi.org/10.18502/ijm.v13i5.7440

Keywords: Treatment; Leishmaniasis; Cutaneous; Anthroponotic; Clinical trial; Protocol

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 diag- nosis 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.