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      An Open Study to Evaluate Effectiveness and Tolerability of a Nail Oil Composed of Vitamin E and Essential Oils in Mild to Moderate Distal Subungual Onychomycosis

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          Abstract

          Background: Onychomycosis is the most common nail disease and can affect both fingernails and toenails. When possible, topical treatment is generally preferred both by patients and physicians because it is associated with lower risk of systemic side effects and drug interactions than oral antifungals, avoiding laboratory monitoring. Objective: The aim of our study was to evaluate the efficacy, tolerability, and patient’s compliance of a new topical antifungal containing vitamin E and essential oils of lime, oregano, and tea tree. Patients and Methods: We enrolled 20 patients with mild-moderate distal subungual onychomycosis due to dermatophytes or non-dermatophyte molds. The product was applied once daily on the periungual tissues and on the nail plate for 6 months. Follow-up without therapy continued for another 6 months in order to evaluate the product’s effect maintenance. Periodic evaluation of treatment efficacy was performed by standardized photography and mycological examination (KOH + culture) of the target nail at baseline (T0), after 3 months (T1) and 6 months (T2) of therapy, and after 6 months of follow-up (T3). Results: At the end of the 12-month study, the majority of patients achieved a complete cure of onychomycosis (78.5%). All patients were very satisfied by the treatment. No side effects were recorded. Conclusions: The results of our study indicate that this new topical antifungal containing vitamin E and essential oils of lime, oregano, and tea tree is an effective and safe option for topical therapy of onychomycosis. This topical antifungal nail oil restructures the nail appearance, improving patient’s adherence to therapy and reducing the risk of relapses, maintaining results over time.

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          Most cited references17

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          Antimicrobial activity of essential oils and other plant extracts.

          The antimicrobial activity of plant oils and extracts has been recognized for many years. However, few investigations have compared large numbers of oils and extracts using methods that are directly comparable. In the present study, 52 plant oils and extracts were investigated for activity against Acinetobacter baumanii, Aeromonas veronii biogroup sobria, Candida albicans, Enterococcus faecalis, Escherichia col, Klebsiella pneumoniae, Pseudomonas aeruginosa, Salmonella enterica subsp. enterica serotype typhimurium, Serratia marcescens and Staphylococcus aureus, using an agar dilution method. Lemongrass, oregano and bay inhibited all organisms at concentrations of < or = 2.0% (v/v). Six oils did not inhibit any organisms at the highest concentration, which was 2.0% (v/v) oil for apricot kernel, evening primrose, macadamia, pumpkin, sage and sweet almond. Variable activity was recorded for the remaining oils. Twenty of the plant oils and extracts were investigated, using a broth microdilution method, for activity against C. albicans, Staph. aureus and E. coli. The lowest minimum inhibitory concentrations were 0.03% (v/v) thyme oil against C. albicans and E. coli and 0.008% (v/v) vetiver oil against Staph. aureus. These results support the notion that plant essential oils and extracts may have a role as pharmaceuticals and preservatives.
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            Part I: Onychomycosis: Clinical Overview and Diagnosis

            Onychomycosis is a fungal nail infection caused by dermatophytes, nondermatophytes, and yeast, and is the most common nail disorder seen in clinical practice. It is an important problem because it may cause local pain, paresthesias, difficulties performing activities of daily life, and impair social interactions. In this continuing medical education series we review the epidemiology, risk factors, and clinical presentation of onychomycosis and demonstrate current and emerging diagnostic strategies.
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              Part II: Onychomycosis: Treatment and Prevention of Recurrence

              Onychomycosis is a fungal nail infection caused by dermatophytes, nondermatophytes, and yeast, and is the most common nail disorder seen in clinical practice. It is an important problem because it may cause local pain, paresthesias, difficulties performing activities of daily living, and impair social interactions. The epidemiology, risk factors, and clinical presentation and diagnosis of onychomycosis were discussed in the first article in this continuing medical education series. In this article, we review the prognosis and response to onychomycosis treatment, medications for onychomycosis that have been approved by the US Food and Drug Administration, and off-label therapies and devices. Methods to prevent onychomycosis recurrences and emerging therapies are also described.
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                Author and article information

                Journal
                SAD
                SAD
                10.1159/issn.2296-9160
                Skin Appendage Disorders
                S. Karger AG
                2296-9195
                2296-9160
                2020
                January 2020
                25 October 2019
                : 6
                : 1
                : 14-18
                Affiliations
                Department of Experimental, Diagnostic and Specialty Medicine, Division of Dermatology, University of Bologna, Bologna, Italy
                Author notes
                *Aurora Alessandrini, Department of Experimental, Diagnostic and Specialty Medicine, Division of Dermatology, University of Bologna, Via Massarenti, 1, IT–40138 Bologna (Italy), E-Mail aurora.alessandrini3@unibo.it
                Article
                503305 PMC6995982 Skin Appendage Disord 2020;6:14–18
                10.1159/000503305
                PMC6995982
                32021856
                9acfc352-9002-4e22-b23b-1ae706888c49
                The Author(s). Published by S. Karger AG, Basel

                This article is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (CC BY-NC-ND). Usage and distribution for commercial purposes as well as any distribution of modified material requires written permission. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

                History
                : 31 July 2019
                : 10 September 2019
                Page count
                Figures: 4, Pages: 5
                Categories
                Clinical Investigations – Research Article

                Oncology & Radiotherapy,Pathology,Surgery,Dermatology,Pharmacology & Pharmaceutical medicine
                Onychomycosis,Lime oil,Oregano oil,Topical therapy,Tea tree oil,Tocopherol acetate

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