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Efficacy of Adjunctive Topical Liposomal Clarithromycin on Systemic Glucantime in Old World Cutaneous Leishmaniasis: A Pilot Clinical Study Publisher



Hakamifard A1 ; Radmehr R2 ; Sokhanvari F3 ; Sherkat F4 ; Hariri A5 ; Varshosaz J6 ; Shahmoradi Z7 ; Feizi A8 ; Abtahinaeini B9 ; Pourmahdiboroujeni M10
Authors
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Authors Affiliations
  1. 1. Department of Infectious Diseases, Cancer Prevention Research Center, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran
  2. 2. Department of Infectious Diseases, Hormozgan University of Medical Sciences, Bandar Abbas, Iran
  3. 3. Skin Diseases and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
  4. 4. Faculty of Pharmacy, Debrecen University, Debrecen, Hungary
  5. 5. Pharmaceutical Biotechnology, School of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Isfahan, Iran
  6. 6. Drug Delivery System Research Center, Department of Pharmaceutics, School of Pharmacy, Isfahan University of Medical Sciences, Isfahan, Iran
  7. 7. Department of Dermatology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran
  8. 8. Department of Biostatistics and Epidemiology, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran
  9. 9. Pediatric Dermatology Division of Department of Pediatrics, Imam Hossein Children’s Hospital, Isfahan University of Medical Sciences, Isfahan, Iran
  10. 10. Student Research Committee, Isfahan University of Medical Sciences, Isfahan, Iran

Source: Frontiers in Pharmacology Published:2023


Abstract

Aim: This study aimed to investigate the effects of topical liposomal clarithromycin in combination with meglumine antimoniate (Glucantime®) on cutaneous leishmaniasis (CL) lesions. Methods: 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. Results: 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 (p = 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 (p = 0.006) and 5.47 ± 5.83 to 0.76 ± 0.88 in the placebo group (p = 0.03). Moreover, the size of lesions in the intervention group was significantly reduced compared to that in the placebo group (p = 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. Conclusion: 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. Systematic Review Registration: https://www.irct.ir/trial/46611. Copyright © 2023 Hakamifard, Radmehr, Sokhanvari, Sherkat, Hariri, Varshosaz, Shahmoradi, Feizi, Abtahi-Naeini and Pourmahdi-Boroujeni.
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