Addressing filamentous fungi-related onychomycosis in the era of antifungal resistance: assessment of Zataria multiflora nanostructured lipid carrier topical gel in a double-blinded clinical trial
- سال انتشار: 1404
- محل انتشار: مجله قارچ شناسی پزشکی، دوره: 11، شماره: 0
- کد COI اختصاصی: JR_CUMM-11-0_001
- زبان مقاله: انگلیسی
- تعداد مشاهده: 99
نویسندگان
Invasive Fungi Research Center, Communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran
Laboratory of Advanced Analysis in Biochemistry and Molecular Biology (LAABBM), Department of Biochemistry, Federal University of Rio de Janeiro (UFRJ), University City, Rio de Janeiro ۲۱۹۴۱-۹۰۹, RJ, Brazil
Department of Dermatology, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran
Department of Dermatology, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran
Invasive Fungi Research Center, Communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran
Student Research Committee, Mazandaran University of Medical Sciences, Sari, Iran
Student Research Committee, Mazandaran University of Medical Sciences, Sari, Iran
Department of Medical Mycology, Imam Reza Hospital, School of Medicine, Ardabil University of Medical Sciences, Ardabil, Iran
Department of Dermatology, Faculty of Medicine, Sari Branch, Islamic Azad University, Sari, Iran
Student Research Committee, Mazandaran University of Medical Sciences, Sari, Iran
چکیده
Background and Purpose: Onychomycosis, a prevalent fungal infection affecting the nails, presents considerable difficulties in clinical treatment. Zataria multiflora (Zat), with its known antifungal properties, presents a promising approach for treatment. The present study focused on the evaluation of the effectiveness of Zat-NLC ۱% gel against mold-associated onychomycosis, compared to a placebo.Materials and Methods: The Zat-loaded nanostructured lipid carriers (Zat-NLCs) were prepared and optimized by utilizing an ultrasonic probe approach. Antifungal susceptibility testing followed Clinical and Laboratory Standards Institute M۳۸-A۳ guidelines on the most common dermatophytes and non-dermatophytes fungal species. A double-blind trial with ۴۰ participants (۲۰ volunteers from each gender, equally divided into two groups, namely Zat-NLCs ۱% gel and placebo receivers) evaluated Zat-NLC ۱% gel efficacy. Causative agents were identified at the species level using a polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) method.Results: A mono-dispersed suspension of spherical nanoparticles with zeta potential, Z-average, and polydispersity index of -۲۶.۶±۷.۷ mV, ۲۷۳.۹±۳ nm, and ۰.۳۶۹±۰.۰۳, respectively, was achieved with no cytotoxicity. The Zat-NLCs demonstrated a significant inhibitory effect on both dermatophytes and non-dermatophyte fungal growth, in vitro. Effective improvement was observed in mycological criteria, compared to the placebo group (P< ۰.۰۰۵) after ۲ weeks of treatment. The mycological cure rate was ۷۰% for Zat-NLCs gel after only ۲ weeks. The results were notably different from those observed in the placebo group following the same duration of application (۷۰% vs. ۵۵%). However, the difference was insignificant in the mentioned groups after ۴ weeks of application due to the prescription of routine antifungals for onychomycosis. The PCR-RFLP outputs revealed T. mentagrophytes/interdigitale complex and A. section Flavi as the predominant isolated species of dermatophytes and non-dermatophytes, respectively.Conclusion: Nanoscale colloidal systems loading with antifungals might be strongly considered a better and more efficient cure for mold-related dermatophytosis.کلیدواژه ها
Clinical trials, Onychomycosis, Filamentous fungi, Nanostructured lipid carrier, Zataria multifloraاطلاعات بیشتر در مورد COI
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