Nanofibrous patches for targeted therapy of cutaneous leishmaniasis caused by Leishmania major: a preclinical amphotericin B platform

Cutaneous leishmaniasis (CL) remains a significant public health challenge in endemic regions, particularly where access to safe and patient-friendly treatments is limited. Amphotericin B (AmB), although highly active against Leishmania, is restricted by systemic toxicity and the need for parenteral administration. In this study, AmB-loaded bioactive nanofibrous patches were fabricated using a dual-nozzle electrospinning method incorporating chitosan, gelatin, and polyvinyl alcohol. The resulting nanofibers were structurally characterized by scanning electron microscopy, Fourier-transform infrared spectroscopy, and X-ray diffraction. Drug loading was uniform, and in vitro release demonstrated a sustained profile with approximately 82% cumulative release at 72 h. Cytocompatibility was confirmed in human dermal fibroblasts and THP-1 cells. The therapeutic performance was further assessed in BALB/c mice using short- and long-term treatment protocols. AmB-loaded patches produced a significant reduction in lesion size compared with untreated and placebo groups, and the treatment outcome was comparable to Glucantime^® (Day 21) and SinaAmpholeish^® (Day 63). No local irritation or observable systemic toxicity was noted. Overall, these findings indicate that nanofiber-mediated topical delivery of AmB provides a promising localized treatment approach for CL and warrants further investigation in translational and clinical studies.