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There are a limited number of chemotherapeutic agents for the treatment canine visceral leishmaniasis (CVL). This study aimed to formulate and assess micellar formulation of miltefosine (MTF) to increase antileishmanial therapeutic effects in dogs naturally infected by Leishmania (L) infantum for the first time. MTF loaded pluronic F127 (PF/MTF) micelles were formulated and coated with chitosan (Cs/PF/MTF). Toxicity of compounds was evaluated. The in vitro and in vivo antileishmanial effect of Cs/PF/MTF was examined in L. infantum promastigotes and amastigotes as well as naturally infected dogs by L. infantum. In-vitro efficacy studies in promastigotes and amastigotes demonstrated that inhibitory concentration (IC50) of Cs/PF/MTF was significantly lower in comparison to miltefosine. In vivo data showed that Cs/PF/MTF is more effective against CVL compared with miltefosine alone. The result of this study indicated that intravenous injection of new formulation of Cs/PF/MTF was tolerated and treated on L. infantum naturally infected dogs with the dosages of 170 μg/kg daily for 28 days., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Ltd.) more...

Treatment of Cutaneous leishmaniasis (CL) is based on using antimoniate derivatives; patients' compliance for systemic injections is low due to the pain and systemic complications. In this randomized open trial, the efficacy of intra-lesional (IL) injections of meglumine antimoniate (MA) once a week vs. twice a week in the treatment of Anthrpoponothic CL caused by L. tropica was studied. Eligible volunteer patients were selected according to inclusion/exclusion criteria. The included patients were randomly allocated to receive IL-MA injections once a week or twice a week. The primary outcome was set as complete healing of the lesion(s), and defined as complete re-epithelialization and absence of induration in the lesions. A total of 180 parasitologicaly proven CL patients caused by L. tropica were recruited, 90 patients were treated with weekly IL-MA and 90 patients received IL-MA twice a week. The complete cure was 87.9% vs. 89.2% in the group received weekly and twice a week IL-MA injections, respectively (P = 0.808). Patients' compliance was acceptable and side effects were limited to a few local allergic reactions to MA. Median time to healing was significantly shorter in patients who received IL-MA twice a week (median ± SE) 37±3.8, (CI: 29.6-44.4) days compared to whom received IL-MA once a week 60±2.3, (CI: 55.6-64.5) days (P< 0.001), however the number of injections was higher in group who received IL-MA twice a week (12 vs. 9 injections). In conclusion, the rate of cure in the group of CL patients with IL-MA twice a week was not significantly different from the group who received IL-MA once a week shorten, but the duration of healing was shorter in the group who received IL-MA twice a week while the group received more injections so is recommended to use IL-MA once a week due to the fact the compliance is acceptable with limited side effects. Clinical Trial Registration: IRCT20081130001475N13; https://en.irct.ir/., Competing Interests: The authors have declared that no competing interests exist. more...

Background: Old World cutaneous leishmaniasis (OWCL) is endemic in Iran and most cases of cutaneous leishmaniasis (CL) are caused by Leishmania major , and then Leishmania tropica, and rarely by Leishmania infantum ., Objective: We aimed to describe clinical variants of OWCL and their treatments., Method: Through literature search in PubMed, Scopus and Embase and google scholar, we have found articles about variant clinical pictures of OWCL and their treatments., Results: The following clinical variants of OWCL namely; localized forms, zosteriform, erysipeloid, eczematoid, warty, localized Leishmania lymphadenitis, sporotrichoid, hyperkeratotic, impetiginized, mucosal involvement in CL, lupoid leishmaniasis, chronic lesions due to leishmanization, disseminated cutaneous leishmaniasis, reactivation of CL after transplantation and coexistence of CL with other diseases, are reported from Iran. The mainstay of therapy remains pentavalent antimonial compounds and cryotherapy is an adjuvant to therapy. Treatment with antifungal agents, miltefosine, amphotericin B and herbal extract such as ZH-E have also been used. Treatment of CL in chronic cases and in immunosuppressed patients is difficult and relapse may occur., Conclusion: In clinical variants of CL with long duration and multiple lesions, systemic pentavalent antimonial compounds are first step of therapy. In case of incomplete response or resistant to classic treatment, combination therapy is indicated. more...

Cutaneous leishmaniasis has been recognized as a major public health problem in several countries. Pentavalent antimonies, meglumine antimoniate and sodium stibogluconate, have been considered as standard treatment for leishmaniasis. Side effects have been reported to be increased hepatic enzyme levels and electrocardiographic abnormalities. We performed this study to evaluate the influence of meglumine antimoniate on some liver, kidney, and pancreas function tests. Eighty patients fulfilled the study criteria. Forty-one (51.3%) patients were female and the mean age of the patients was 30.4 +/- 15.7 years. Blood samples were taken to evaluate liver, kidney, and pancreas function tests before and after treatment with intramuscular injections of MA at a dose of 20 mg Sb(+5)/kg/day for 15 days. Mean serum levels of blood urea nitrogen, creatinine, sodium, total and direct bilirubin, aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase significantly increased after treatment, although most of them were within normal ranges. There were no significant differences in serum levels of potassium, amylase, lipase, and gamma-glutamyl transpeptidase before and after treatment. In conclusion it can be stated that one course of treatment with 20 mg Sb(+5)/kg/day MA for 15 days does not significantly alter the liver, kidney and pancreas function tests in patients with cutaneous Leishmaniasis. more...

Objective: To determine the efficacy and safety of imiquimod in combination with meglumine antimoniate in treating cutaneous leishmaniasis., Design: Prospective, randomized, assessor-blind, parallel-design, placebo-controlled trial., Setting: Two primary care health clinics., Patients: One hundred nineteen patients (59 patients in the imiquimod group and 60 in the placebo group) were included in the study., Interventions: Patients were randomly assigned to receive a combined 4-week course of imiquimod or placebo with meglumine antimoniate treatment (20 mg/kg of pentavalent antimony daily for 2 weeks) in an endemic area of Leishmania tropica., Main Outcome Measures: The primary end point was clinical cure, defined as more than 75% reduction in the size of lesions compared with baseline at week 8., Results: At the end of the 4-week treatment period, clinical cure was similar in both groups (11 patients [18.6%] in the imiquimod-treated group vs 18 patients [30.0%] in the placebo group) (P = .15). Four weeks after the end of treatment, 26 patients (44.1%) and 29 patients (48.3%) in the imiquimod-treated and placebo groups, respectively, were cured (P = .64). Pruritus and burning sensation were reported by 3 patients treated with imiquimod and by no patients treated with placebo., Conclusion: This study showed no beneficial effect of combining a 4-week course of treatment with 5% imiquimod cream and a standard course of treatment with meglumine antimoniate in patients with cutaneous leishmaniasis in an endemic area of L tropica., Trial Registration: isrctn.org Identifier:ISRCTN77659407 and Cochrane Skin Group Identifier: CSG Trial No. 32. more...