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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
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 lei...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Tehran University of Medical Sciences
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8629814/ https://www.ncbi.nlm.nih.gov/pubmed/34900170 http://dx.doi.org/10.18502/ijm.v13i5.7440 |
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author | Eskandari, Seyed Ebrahim Khamesipour, Ali Jaafari, Mahmoud Reza Javadi, Amir Mohammadi, Akram Miramin Valian, Hossein Keshavarz Nassiri-Kashani, Mansour Goyonlo, Vahid Mashayekhi Firooz, Alireza |
author_facet | Eskandari, Seyed Ebrahim Khamesipour, Ali Jaafari, Mahmoud Reza Javadi, Amir Mohammadi, Akram Miramin Valian, Hossein Keshavarz Nassiri-Kashani, Mansour Goyonlo, Vahid Mashayekhi Firooz, Alireza |
author_sort | Eskandari, Seyed Ebrahim |
collection | PubMed |
description | 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 doubleblind 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. |
format | Online Article Text |
id | pubmed-8629814 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Tehran University of Medical Sciences |
record_format | MEDLINE/PubMed |
spelling | pubmed-86298142021-12-10 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 Eskandari, Seyed Ebrahim Khamesipour, Ali Jaafari, Mahmoud Reza Javadi, Amir Mohammadi, Akram Miramin Valian, Hossein Keshavarz Nassiri-Kashani, Mansour Goyonlo, Vahid Mashayekhi Firooz, Alireza Iran J Microbiol Original Article 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 doubleblind 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. Tehran University of Medical Sciences 2021-10 /pmc/articles/PMC8629814/ /pubmed/34900170 http://dx.doi.org/10.18502/ijm.v13i5.7440 Text en Copyright © 2021 The Authors. Published by Tehran University of Medical Sciences https://creativecommons.org/licenses/by-nc/4.0/This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International license (https://creativecommons.org/licenses/by-nc/4.0/). Non-commercial uses of the work are permitted, provided the original work is properly cited. |
spellingShingle | Original Article Eskandari, Seyed Ebrahim Khamesipour, Ali Jaafari, Mahmoud Reza Javadi, Amir Mohammadi, Akram Miramin Valian, Hossein Keshavarz Nassiri-Kashani, Mansour Goyonlo, Vahid Mashayekhi Firooz, Alireza 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8629814/ https://www.ncbi.nlm.nih.gov/pubmed/34900170 http://dx.doi.org/10.18502/ijm.v13i5.7440 |
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