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

Introduction

Onychomycosis is the most common nail infective disorder and it is responsible for about 50% of all consultations for nail disorders. Onychomycosis has been reported as a gender- and age-related disease, as it is more prevalent in males and its prevalence increases with age in both genders [1]. Predisposing factors include mainly systemic diseases, i.e., diabetes mellitus, peripheral arterial disease, immunosuppression.

In most of the cases, onychomycosis is caused by anthropophylic dermatophytes of the Trichophytonspecies.Particularly, Trichophyton rubrumis the most common cause, followed by Trichophyton interdigitale. Scopulariopsis brevicaulis, Fusariumspp.,and Aspergillusspp.are the most common non-dermatophyte molds isolated in onychomycosis, usually in the toenails. Other molds that have been isolated include Acremoniumspp., Alternariaspp., Scytalidiumspp., and other less frequent species. Yeasts represent the last common cause of nail fungal infection, and Candida albicans and Candida parapsilosis are the two most common isolates. Candida onychomycosis is seen in the hands of immunodepressed and diabetic patients [2] and in patients under chronic steroid therapy.

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Onychomycosis can be associated with local pain, paresthesia, reduced quality of life, and impaired social interactions and daily activities [3]. Both the toenails and fingernails can be affected, with the toenails being more commonly involved, and it is commonly associated with a history of tinea pedis or hyperhidrosis [4]. Clinically, there are different clinical types of onychomycosis, depending on the modality of nail invasion: distal subungual onychomycosis (DSO), the most common type, white superficial onychomycosis, proximal subungual onychomycosis, or total onychomycosis.

The clinical signs of DSO include white or yellow nail discoloration, nail plate thickening with subungual hyperkeratosis and onycholysis. The diagnosis of onychomycosis can be suspected on clinical features alone but laboratory isolation of the fungus through direct microscopy with potassium hydroxide (KOH) and culture examination still remains the gold standard.

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Treatment is chosen depending on the modality of nail invasion, fungus species, and the number of affected nails. The difficulty in treating onychomycosis results from the deep-seated nature of the infection within the nail unit and the difficulty of drugs to effectively reach all sites. In case of DSO involving more than 50% of the nail and more than 3 nails, systemic oral therapy with terbinafine, itraconazole, or fluconazole represents the first choice of treatment. On the contrary, if the nail invasion is restricted to less than 50% of the nail and less than 3 nails are involved, the treatment is based on topical application of antifungals, conveyed in cream, gel, or nail lacquers [2]. Topical therapy is generally preferred both by patients and physicians because it is associated with lower risk of systemic side effects and drug interactions, avoiding laboratory monitoring [5]. However, the nail has a slow growth rate and its composition makes it a formidable barrier to the permeation and diffusion of drugs, requiring the right vehicle and a long duration of therapy, usually 6-8 months or longer, ideally until a healthy nail has regrown [6]. The goal of onychomycosis therapy is both to eliminate the infecting fungal organism and to restore the normal appearance of the nail (mycological and clinical cure, respectively). However, we must not forget that clinical cure does not always follow mycological cure, because toenails often show traumatic alterations or dystrophies that are not reversed by antifungal therapy.

The aim of our study was to evaluate the efficacy and tolerability of a new topical antifungal containing vitamin E and essential oil of lime, oregano, and tea tree. This combination of essential oils, with low percentage vehiculated in tocopheryl acetate, resulted in the most active agents against dermatophytes and molds in in vitro tests.

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