A Novel Niosomal Gel for Topical Delivery of Miltefosine Against Trichophyton indotineae Dermatophytosis in Animal Model.

Abstract

Introduction: Dermatophytosis, a cutaneous fungal infection worldwide, is generally localised to the skin's superficial layers and keratinised structures. Although most agents are susceptible to current antifungal drugs available in clinical settings, frequent relapses and failures, especially in cases due to Trichophyton indotineae, have been frequently reported. Therefore, alternative targets and therapeutic approaches are highly required. In the present study, we compared the efficacies of terbinafine with conventional and niosomal forms of miltefosine (MFS) against dermatophytosis in the guinea pig model.

Material and methods: Initially, 30 guinea pigs were divided into five groups (e.g., untreated control, treated groups by MFS niosomal gel 1%, MFS gel 1%, terbinafine 1% and niosome) and were infected with terbinafine-resistant Trichophyton indotineae and subsequently scored both clinically and mycologically until day 35 of inoculation. MFS was encapsulated into niosomes, elastic vesicles made of non-ionic surfactants that enhance drug delivery through the skin.

Results: Results showed that the MFS niosomal gel 1% significantly reduced lesion scores, mycological evidence of infection and inflammation compared to the untreated control and terbinafine-treated groups (p < 0.05). Moreover, the lesion score in the niosomal gel and terbinafine groups did not differ from the untreated control (p > 0.05). Histopathological analysis confirmed reduced epidermal thickening and fungal burden in treated models with the MFS niosomal gel 1%.

Conclusion: The findings highlighted MFS niosomal gel 1% as a potentially effective, targeted therapy for drug-resistant T. indotineae, offering a safer and more effective alternative to topical and oral antifungal treatments. However, further studies are warranted to continue correlating these findings with more clinical outcomes.