Open AccessCombination 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
Author(s) -
Seyed Ebrahim Eskandari,
Ali Khamesipour,
Mahmoud Reza Jaafari,
Amir Javadi,
Akram Miramin Mohammadi,
Hossein Keshavarz Valian,
Mansour Nassiri-Kashani,
Vahid Mashayekhi Goyonlo,
Alireza Firooz
Publication year - 2021
Publication title -
iranian journal of microbiology.
Language(s) - English
Resource type - Journals
eISSN - 2008-4447
pISSN - 2008-3289
DOI - 10.18502/ijm.v13i5.7440
Subject(s) - meglumine antimoniate , medicine , leishmania tropica , cutaneous leishmaniasis , randomized controlled trial , leishmaniasis , regimen , placebo , clinical trial , amphotericin b , surgery , pharmacology , dermatology , immunology , pathology , antifungal , alternative medicine
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.