Enhanced treatment in cutaneous dermatophytosis management by Zataria multiflora-loaded nanostructured lipid carrier topical gel: A randomized double-blind placebo-controlled clinical trial
Rattachement africain : ir, gb, us. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
The global rising incidence of skin mycosis especially dermatophytes currently affects more than 20–25% of the world population. It is believed that nanotechnology can aid in the efficient treatment of this skin disease. The present study, therefore, aimed to employ nanostructured lipid carriers (NLCs) in a gel formulation for a more effective delivery of Zataria multiflora (ZM) essential oils through the skin to manage mild to moderate cutaneous dermatophytosis. Zataria multiflora-loaded nanostructure lipid carriers (ZM-NLCs) were prepared and optimized by utilizing an ultrasonic probe approach and formulated the ZM-NLCs as a 1% w/w carbopol gel after confirming the NLCs-related characteristics. In vitro antifungal susceptibility testing was performed on 20 common dermatophyte species based on the CLSI M38-A3 guidelines. A total of 80 volunteers (40 volunteers from each gender, equally divided into two groups: ZM-NLCs gel and placebo receivers) participated in this clinical randomized, double-blind placebo-controlled study. Clinical manifestations (itching, scaling, size of lesion and inflammation), as well as mycological findings such as KOH-direct examination test and culture, were evaluated after 2 and 4 weeks of topical application. Molecular identification of the strains isolated from the patient's lesions was also performed to the species level using a PCR-RFLP method. A mono-dispersed suspension of spherical nanoparticles with zeta potential, Z-average and PDI index of −26.6 ± 7.7 mV, 273.5 ± 4 nm and 0.33 ± 0.03, respectively was achieved with no cytotoxicity. Apart from the significant inhibitory effect of ZM-NLCs on fungal growth, the application of the ZM-NLCs gel resulted in an effective diminution in inflammation (87.5%), itching (90%) and scaling (95%) among the volunteers after 4 weeks. The aforementioned signs/symptoms were significant when compared to the patients receiving a placebo (p < 0.005). A reduction/disappearance of the lesion was also significantly reported in the ZM-NLCs gel receivers. Compared with placebo receivers, meaningful negative results for both direct examination and culture were observed (17.5% vs 70% for KOH-direct examination and 12.5% vs 57.5% for culture) for patients who received ZM-NLCs gel after 2 weeks of prescription. PCR-RFLP outputs revealed T. mentagrophytes/interdigitale complex as the predominant isolated species from cutaneous lesions. In conclusion, Zataria multiflora-NLCs gel application displayed a more rapid cure time with no adverse side effects compared to placebo demonstrating the efficacious nature of NLCs.
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.
Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Enhanced treatment in cutaneous dermatophytosis management by Zataria multiflora-loaded nanostructured lipid carrier topical gel: A randomized double-blind placebo-controlled clinical trial
- Date Crossref
- 01/02/2023
- Éditeur
- Elsevier BV
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Mazandaran University of Medical Sciences Student Research Committee pays non établi dans la noticeUniversité ou école supérieure
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Imam Khomeini Hospital pays non établi dans la noticeÉtablissement de santé
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Islamic Azad University Sari Branch pays non établi dans la noticeUniversité ou école supérieure
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University of Huddersfield Department of Pharmacy pays non établi dans la noticeUniversité ou école supérieure
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University of Sussex pays non établi dans la noticeUniversité ou école supérieure
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Lupin Pharmaceuticals (United States) pays non établi dans la noticeEntreprise
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Faculty of Medicine Department of Dermatology pays non établi dans la noticeUniversité ou école supérieure
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School of Medicine Department of Medical Mycology pays non établi dans la noticeUniversité ou école supérieure
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Lupin Research Inc pays non établi dans la noticeEntreprise
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School of Life Sciences Pharmaceutics Research Laboratory pays non établi dans la noticeUniversité ou école supérieure
Student Research Committee — Mazandaran University of Medical Sciences, Imam Khomeini Hospital et Islamic Azad University Sari Branch, avec 7 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.