Efficacy of intra-lesional injections of meglumine antimoniate once a week vs. twice a week in the treatment of cutaneous leishmaniasis caused by L. tropica in Iran: A randomized controlled clinical trial.

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/.

Evaluation of meglumine antimoniate effects on liver, kidney and pancreas function tests in patients with cutaneous leishmaniasis.

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.

Imiquimod in combination with meglumine antimoniate for cutaneous leishmaniasis: a randomized assessor-blind controlled trial.

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.