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 Goyonlo
,
Alireza Firooz
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.
https://www.who.int/news-room/fact-sheets/detail/leishmaniasis
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| Files | ||
| Issue | Vol 13 No 5 (2021) | |
| Section | Original Article(s) | |
| DOI | https://doi.org/10.18502/ijm.v13i5.7440 | |
| Keywords | ||
| Treatment; Leishmaniasis; Cutaneous; Anthroponotic; Clinical trial; Protocol | ||
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