Therapeutic Recommendations for the Treatment of Toenail Onychomycosis in the US.

BACKGROUND: Onychomycosis affects around 14% of individuals in North America and Europe and is undertreated. Treatment is challenging as toenail growth can take 12–18 months, the nail plate may prevent drug penetration, and disease recurrence is common. National guidelines/consensus documents on onychomycosis diagnosis and treatment were last published more than 5 years ago and updated medical guidance is needed. METHODS: This document aims to provide recommendations for the diagnosis and pharmaceutical treatment of toenail onychomycosis following a roundtable discussion with a panel of dermatologists, podiatrists, and a microbiologist specializing in nail disease. RESULTS: There was a general consensus on several topics regarding onychomycosis diagnosis, confirmatory laboratory testing, and medications. Onychomycosis should be assessed clinically and confirmed with microscopy, histology, and/or culture. Terbinafine is the primary choice for oral treatment and efinaconazole 10% for topical treatment. Efinaconazole can also be considered for off-label use for maintenance to prevent recurrences. For optimal outcomes, patients should be counseled regarding treatment expectations as well as follow-up care and maintenance post-treatment. CONCLUSIONS: This article provides important updates to previous guidelines/consensus documents to assist dermatologists and podiatrists in the diagnosis and treatment of toenail onychomycosis. J Drugs Dermatol. 2021;20(10):1076-1084. doi:10.36849/JDD.6291.

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.

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.

Congenital Malalignment of the Great Toenails With Acute Paronychia.

Congenital malalignment of the great toenails (CMGT) has been well documented. In the present case, it was complicated by acute paronychia. It is important for physicians to recognize and treat CMGT to prevent sequelae such as onychocryptosis, onychogryphosis, and recurrent paronychia.

Management of onychomycosis and co-existing tinea pedis.

Onychomycosis is a common nail infection that often co-exists with tinea pedis. Surveys have suggested the diseases co-exist in at least one third of patients, although actual numbers may be a lot higher due to significant under-reporting. The importance of evaluating and treating both diseases is being increasingly recognized, however, data on improved outcomes, and the potential to minimize re-infection are limited. We review a recent post hoc analysis of two large studies treating mild to moderate onychomycosis with efinaconazole topical solution, 10%, demonstrating that complete cure rates of onychomycosis are significantly improved when any co-existing tinea pedis is also treated.

Onychomycosis Diagnosis and Management: Perspectives from a Joint Dermatology-Podiatry Roundtable.

Onychomycosis prevalence is expected to rise as the population ages and the prevalence of diabetes, peripheral vascular disease, and other significant risk factors rise. Until recently, treatment options were limited due to safety concerns with oral antifungals and low efficacy with available topical agents. Efinaconzole and tavaborole were approved by the FDA in 2014 for onychomycosis treatment and provide additional effective topical treatment options for patients with mild-to-moderate disease. Dermatologists and podiatrists both regularly treat onychomycosis, yet there are striking differences between specialties in approach to diagnosis and treatment. In order to explore these differences a joint dermatology-podiatry roundtable of onychomycosis experts was convened. Although it has little effect on mycologic cure, debridement may be a valuable adjunct to oral or topical antifungal therapy, especially in patients with greater symptom burden. However, few dermatologists incorporate debridement into their treatment plans and referral to podiatry may be appropriate for some of these patients. Furthermore, podiatrists may be better equipped to manage patients with concurrent diabetes or peripheral vascular disease and elderly patients who are unable to maintain proper foot hygiene. Once cure is achieved, lifestyle and hygiene practices, maintenance/prophylactic onychomycosis treatment, and proactive tinea pedis treatment in patients and family members may help to maintain patients' cured status.

Luliconazole: a review of a new antifungal agent for the topical treatment of onychomycosis.

Luliconazole is a novel, broad-spectrum, imidazole antifungal under development in the USA as a treatment for dermatophytic skin and nail infections. In vitro, luliconazole is one of the most potent antifungal agents against filamentous fungi including dermatophytes. Luliconazole has been formulated in a 10% solution with unique molecular properties, which allow it to penetrate the nail plate and rapidly achieve fungicidal levels in the nail unit. These properties make luliconazole a potent compound in the treatment of onychomycosis. This article reviews the development of luliconazole solution, 10% its molecular properties, preclinical and clinical data and its future perspectives for the treatment of fungal infections.

The epidemiology, etiology, and pathophysiology of onychomycosis.

The prevalence of onychomycosis in the United States is estimated to be at least 12%; prevalence increases with increasing age and is highest in individuals more than 65 years of age. Trichophyton rubrum, which also causes tinea pedis, is responsible for approximately 90% of cases of toenail onychomycosis. Risk factors include a family history of onychomycosis and previous injury to the nails, as well as advanced age and compromised peripheral circulation. Patients with compromised immune function may have an increased risk for onychomycosis and are susceptible to infection with less common dermatophytes and nondermatophyte organisms.

Diagnosis, clinical implications, and complications of onychomycosis.

The diagnosis of onychomycosis is suggested by the clinical presentation as well as the family history and patient age. The definitive diagnosis of onychomycosis is based on (1) establishing the presence or absence of fungal elements using laboratory methods and/or (2) identifying the fungus using fungal culture or, in the future, by polymerase chain reaction as new developments emerge in this technology, making more widespread application of this technique possible.

Current and emerging options in the treatment of onychomycosis.

Currently approved options for the treatment of onychomycosis include systemic therapy (the antifungal agents fluconazole, itraconazole, and terbinafine), topical agents (ciclopirox, which has been available since 1996, efinaconazole, currently pending approval), and laser systems. Phase III studies on another topical, tavaborole, have been completed and this medication also shows promise. Mechanical modalities are sometimes used but are seldom necessary. Recurrence of infection is common; the risk for recurrence may be reduced by adherence to preventive measures, especially avoiding (if possible) or promptly treating tinea pedis infections.

Promoting and maintaining or restoring healthy nails: practical recommendations for clinicians and patients.

The American Academy of Dermatology guidelines for managing patients with onychomycosis, published almost 2 decades ago, provide sound, basic recommendations for clinicians. This article provides a quick reference for clinicians and includes a handout for patients to support the health care provider's educational efforts.

Longitudinal melanonychia: when to biopsy and is dermoscopy helpful?

Longitudinal melanonychia (LM) is a common presenting problem in general dermatology, and represents a diagnostic challenge to clinicians given its broad differential diagnosis that includes both benign and malignant entities. The decision of when a biopsy is required is incredibly challenging for dermatologists. Dermoscopy is a noninvasive technique that enhances the clinical evaluation of LM, and has demonstrated potential in improving the clinical decision making as to whether or not to biopsy LM. However, it is critical for clinicians to understand the limitations of dermoscopy, and that although it is able to add new criteria for the diagnosis of ungual pigmentation, it does not replace histopathologic diagnosis. Biopsy of the nail unit should be performed in any case where doubt based on the clinical evaluation exists.