AUTHOR=Hakamifard Atousa , Radmehr Reza , Sokhanvari Fatemeh , Sherkat Fatemeh , Hariri Amirali , Varshosaz Jaleh , Shahmoradi Zabihollah , Feizi Awat , Abtahi-Naeini Bahareh , Pourmahdi-Boroujeni Mahsa 

TITLE=Efficacy of adjunctive topical liposomal clarithromycin on systemic Glucantime in Old World cutaneous leishmaniasis: a pilot clinical study

JOURNAL=Frontiers in Pharmacology

VOLUME=14

YEAR=2023

URL=https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2023.1280240

DOI=10.3389/fphar.2023.1280240

ISSN=1663-9812

ABSTRACT=<p><bold>Aim:</bold> This study aimed to investigate the effects of topical liposomal clarithromycin in combination with <italic>meglumine antimoniate</italic> (Glucantime<sup>®</sup>) on cutaneous leishmaniasis (CL) lesions.</p><p><bold>Methods:</bold> This pilot, randomized, double-blinded clinical trial was conducted on patients with CL lesions. Patients were randomly assigned to two groups: the first group received liposomal clarithromycin in combination with Glucantime for 28 days, while the second group received Glucantime and a placebo. Afterward, patients were followed up at 1.5, 3, and 6 months after treatment initiation and were evaluated for recovery time, induration, and size of the lesions.</p><p><bold>Results:</bold> Sixty patients with CL lesions were divided into two separate groups with 30 members each and were examined. Within-group analysis revealed that recovery time in the clarithromycin group was 26.65 ± 5.12 days, while in the placebo group, it was 32.84 ± 24.43, which was statistically insignificant (<italic>p</italic> = 0.18). Lesion size comparison in the first and last follow-ups reduced in both groups: 7.73 ± 4.31 to 0.48 ± 0.50 in the clarithromycin group (<italic>p</italic> = 0.006) and 5.47 ± 5.83 to 0.76 ± 0.88 in the placebo group (<italic>p</italic> = 0.03). Moreover, the size of lesions in the intervention group was significantly reduced compared to that in the placebo group (<italic>p</italic> = 0.02). Recognizable induration reduction was observed in the clarithromycin group (2.60 ± 0.77 to 1.0 ± 0.00). No adverse effects attributable to clarithromycin were reported.</p><p><bold>Conclusion:</bold> The administration of liposomal clarithromycin in combination with systemic Glucantime had a significant beneficial effect on reducing lesion size in leishmaniasis. Further studies on larger populations are recommended.</p><p><bold>Systematic Review Registration</bold>: <ext-link ext-link-type="uri" xlink:href="https://www.irct.ir/trial/46611" xmlns:xlink="http://www.w3.org/1999/xlink">https://www.irct.ir/trial/46611</ext-link>.</p>