A Double‐Blind Randomised Clinical Trial of Terbinafine‐Nanostructured Lipid Carriers: Should We Anticipate This Strategy for Effective Topical Treatment of Onychomycosis?

PMCID: PMC12171949

PMID: 40525269

DOI: 10.1111/myc.70076

Journal: Mycoses

Publication Date: 2025-6-17

Authors: Parsay S, Saeedi M, Abastabar M, Hedayati MT, Rahimnia SM, et al.

Key Points

• Nanostructured lipid carriers enabled a more targeted and efficient delivery of terbinafine for onychomycosis treatment
• Clinical severity index reduction of 45% with TBF-NLCs gel compared to 30% with standard cream
• Potential to reduce systemic drug exposure and minimize adverse effects through localized nanomedicine approach

Summary

This innovative study addressed the critical challenge of onychomycosis treatment by developing a novel nanostructured lipid carrier (NLC) gel formulation of terbinafine (TBF) to improve drug delivery and minimize systemic side effects. The researchers created a 1% w/w carbopol gel containing TBF-loaded nanoparticles, characterized by a spherical morphology with a Z-average of 131.7 ± 5.32 nm and high encapsulation efficiency of 83.51 ± 3.52%.

In a randomized, double-blind clinical trial involving 60 volunteers, the TBF-NLCs gel demonstrated superior clinical outcomes compared to traditional TBF cream. The severity index reduced from 65% to 35% in the TBF cream group and from 55% to 10% in the TBF-NLCs group. Critically, the NLC formulation showed enhanced antifungal efficacy against multiple fungal species, including Fusarium, Trichophyton, and Candida, with significantly lower minimum inhibitory concentrations (MICs) compared to standard TBF solution.