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...
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| Format: | Article |
| Language: | English |
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Tehran University of Medical Sciences
2021-10-01
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| Series: | Iranian Journal of Microbiology |
| Subjects: | |
| Online Access: | https://ijm.tums.ac.ir/index.php/ijm/article/view/2916 |
| _version_ | 1818976083541753856 |
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| author | Seyed Ebrahim Eskandari Ali Khamesipour Mahmoud Reza Jaafari Amir Javadi Akram Miramin Mohammadi Hossein Keshavarz Valian Mansour Nassiri-Kashani Vahid Mashayekhi Goyonlo Alireza Firooz |
| author_facet | Seyed Ebrahim Eskandari Ali Khamesipour Mahmoud Reza Jaafari Amir Javadi Akram Miramin Mohammadi Hossein Keshavarz Valian Mansour Nassiri-Kashani Vahid Mashayekhi Goyonlo Alireza Firooz |
| author_sort | Seyed Ebrahim Eskandari |
| collection | DOAJ |
| 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 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. |
| first_indexed | 2024-12-20T16:06:13Z |
| format | Article |
| id | doaj.art-8914cbd58e704a42908b6a684d9172ef |
| institution | Directory Open Access Journal |
| issn | 2008-3289 2008-4447 |
| language | English |
| last_indexed | 2024-12-20T16:06:13Z |
| publishDate | 2021-10-01 |
| publisher | Tehran University of Medical Sciences |
| record_format | Article |
| series | Iranian Journal of Microbiology |
| spelling | doaj.art-8914cbd58e704a42908b6a684d9172ef2022-12-21T19:34:08ZengTehran University of Medical SciencesIranian Journal of Microbiology2008-32892008-44472021-10-0113510.18502/ijm.v13i5.7440Combination 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 trialSeyed Ebrahim Eskandari0Ali Khamesipour1Mahmoud Reza Jaafari2Amir Javadi3Akram Miramin Mohammadi4Hossein Keshavarz Valian5Mansour Nassiri-Kashani6Vahid Mashayekhi Goyonlo7Alireza Firooz8Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Tehran, IranCenter for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Tehran, IranNanotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, IranDepartment of Community Medicine, Qazvin University of Medical Sciences, Qazvin, IranCenter for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Tehran, IranDepartment of Medical Parasitology and Mycology, School of Public Health, Tehran University of Medical Sciences, Tehran, IranCenter for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Tehran, IranSkin 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, IranCenter for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Tehran, IranBackground 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/2916Treatment;Leishmaniasis;Cutaneous;Anthroponotic;Clinical trial;Protocol |
| spellingShingle | Seyed Ebrahim Eskandari Ali Khamesipour Mahmoud Reza Jaafari Amir Javadi Akram Miramin Mohammadi Hossein Keshavarz Valian Mansour Nassiri-Kashani Vahid Mashayekhi Goyonlo Alireza Firooz 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 Iranian Journal of Microbiology Treatment; Leishmaniasis; Cutaneous; Anthroponotic; Clinical trial; Protocol |
| 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 | Treatment; Leishmaniasis; Cutaneous; Anthroponotic; Clinical trial; Protocol |
| url | https://ijm.tums.ac.ir/index.php/ijm/article/view/2916 |
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