UNASSIGNED: Onychomycosis, a multifactorial fungal infection of the nails, shows a global prevalence of about 5.5% and is responsible for 50% of all nail infections. To develop effective management strategies, it is necessary to understand the etiology, pathophysiology, and risk factors of onychomycosis. Oral route of drug delivery is one of the routes utilized to deliver anti-fungal agents, but, has its own limitations like longer duration of treatment, increased adverse effects, and potential for drug interaction. The ungual route has received greater attention due to its localized, non- invasive action and improved patient compliance.
UNASSIGNED: This review comprehensively discusses conventional onychomycosis therapies and patented novel drug delivery systems for the management of onychomycosis including chemical permeation enhancers, non-particulate drug delivery systems, penetration enhancing devices etc., Databases such as PubMed, ResearchGate, and Google Patents were searched by using the keywords onychomycosis and trans-ungual drug delivery.
UNASSIGNED: Enormous research has been conducted and is still ongoing to find the best possible novel drug delivery system for onychomycosis management. Approaches like incorporation of herbal constituents in nano-formulations, inkjet printing, laser devices, iontophoretic techniques, etc. can be employed to make safe and effective drug delivery systems which are regulatory compliant.

Die Onychomykose ist eine Pilzinfektion des Nagelorgans und betrifft sowohl Finger- als auch Zehennägel. Sie wird in Europa vor allem durch Dermatophyten verursacht. Die Diagnostik erfolgt mittels direktmikroskopischer, kultureller und/oder molekularer Methoden aus Nagelmaterial (Nagelspäne). Eine Lokaltherapie mit antimykotischem Nagellack wird bei leichten oder mäßig ausgeprägten Nagelinfektionen empfohlen. Bei mittelschwerer und schwerer Onychomykose wird empfohlen - falls keine Kontraindikationen bestehen - stets oral (systemisch) zu behandeln. Eine antimykotische Kombinationstherapie - oral und topisch - sollte dabei angestrebt werden. Ziel dieser Aktualisierung der deutschen S1-Leitlinie ist es, Auswahl und Durchführung von geeigneter Diagnostik und Therapie zu vereinfachen. Die Leitlinie wurde unter Berücksichtigung aktueller internationaler Leitlinien und den Ergebnissen einer Literaturrecherche durch die Experten der Leitlinienkommission erstellt. Die Leitlinienkommission besteht aus Mandatsträgern der Deutschen Dermatologischen Gesellschaft (DDG), des Berufsverbandes der Deutschen Dermatologen (BVDD), der Deutschsprachigen Mykologischen Gesellschaft (DMykG), der Deutschen Gesellschaft für Hygiene und Mikrobiologie (DGHM), der Deutschen Gesellschaft für Kinder- und Jugendmedizin e.V. (DGKJ), der Arbeitsgemeinschaft pädiatrische Dermatologie (APD) und der deutschen Gesellschaft für Pädiatrische Infektiologie (DGPI). Methodisch wurde die Leitliniengruppe durch die Division of Evidence-based Medicine (dEBM) begleitet. Die Leitlinie wurde nach einem umfangreichen internen und externen Review durch die beteiligten Fachgesellschaften freigegeben.

Onychomycosis is a common chronic fungal infection of the nail that causes discoloration and/or thickening of the nail plate. Oral agents are generally preferred, except in the case of mild toenail infection limited to the distal nail plate. Terbinafine and itraconazole are the only approved oral therapies, and fluconazole is commonly utilized off-label. Cure rates with these therapies are limited, and resistance to terbinafine is starting to develop worldwide. In this review, we aim to review current oral treatment options for onychomycosis, as well as novel oral drugs that may have promising results in the treatment of onychomycosis.

Onychomycosis is a fungal infection of the fingernails and toenails. In Europe, tinea unguium is mainly caused by dermatophytes. The diagnostic workup comprises microscopic examination, culture and/or molecular testing (nail scrapings). Local treatment with antifungal nail polish is recommended for mild or moderate nail infections. In case of moderate to severe onychomycosis, oral treatment is recommended (in the absence of contraindications). Treatment should consist of topical and systemic agents. The aim of this update of the German S1 guideline is to simplify the selection and implementation of appropriate diagnostics and treatment. The guideline was based on current international guidelines and the results of a literature review conducted by the experts of the guideline committee. This multidisciplinary committee consisted of representatives from the German Society of Dermatology (DDG), the German-Speaking Mycological Society (DMykG), the Association of German Dermatologists (BVDD), the German Society for Hygiene and Microbiology (DGHM), the German Society of Pediatric and Adolescent Medicine (DGKJ), the Working Group for Pediatric Dermatology (APD) and the German Society for Pediatric Infectious Diseases (DGPI). The Division of Evidence-based Medicine (dEBM) provided methodological assistance. The guideline was approved by the participating medical societies following a comprehensive internal and external review.

This article describes Neocosmospora keratoplastica as an etiological onychomycosis agent. Ex vivo studies were initially performed to demonstrate the ability of this species to grow and form a well-organized characteristic biofilm on sterilized healthy nails. Based on the history of excellent results, both for antifungal and antibiofilm, of propolis resin gum, we evaluated its activity using artificially formed biofilm. In vitro, the minimal biofilm eradication concentration of the propolis extract (PE) was 375 µg of total polyphenol content (TPC) per mL, while for the propolis gel (PG) it was 450 µg of TPC per mL. In biofilm exposed to the propolis products, a decrease in hyphae and conidia was evident, accompanied by a disorganization of the extracellular matrix. Additionally, this low concentration of PE was able to significantly reduce the number of colony-forming units and the metabolic activity. Furthermore, the treatment of a 15-year nail infection due to N. keratoplastica was carried out exclusively using a topical treatment with a gel containing propolis (30%) with a daily dosage. This treatment achieved complete remission of the onychomycosis in 12 months. It is important to point out that some inconveniences previously reported by other patients treated with propolis extract were eliminated, increasing adherence to treatment.

UNASSIGNED: Dermoscopy is a non-invasive adjuvant diagnostic tool that allows clinicians to visualize microscopic features of cutaneous disorders. Recent studies have demonstrated that dermoscopy can be used to diagnose onychomycosis. We performed this systematic review to identify the characteristic dermoscopic features of onychomycosis and understand their diagnostic utility.
UNASSIGNED: We searched the Medline, Embase, Scopus, and Cochrane databases from conception until May 2021. Studies on the dermoscopic features of onychomycosis were screened. The exclusion criteria were as follows: fewer than 5 cases of onychomycosis, review articles, and studies including onychomycosis cases that were not mycologically verified. Studies on fungal melanonychia were analyzed separately. We adhered to the MOOSE guidelines. Independent data extraction was performed. Data were pooled using a random effects model to account for study heterogeneity. The primary outcome was the diagnostic accuracy of the dermoscopic features of onychomycosis. This was determined by pooling the sensitivity and specificity values of the dermoscopic features identified during the systematic review using the DerSimonian-Laird method. Meta-DiSc version 1.4 and Review Manager 5.4.1 were used to calculate these values.
UNASSIGNED: We analyzed 19 articles on 1693 cases of onychomycosis and 5 articles on 148 cases of fungal melanonychia. Commonly reported dermoscopic features of onychomycosis were spikes or spiked pattern (509, 30.1%), jagged or spiked edges or jagged edge with spikes (188, 11.1%), jagged proximal edge (175, 10.3%), subungual hyperkeratosis (131, 7.7%), ruins appearance, aspect or pattern (573, 33.8%), and longitudinal striae (929, 54.9%). Commonly reported features of fungal melanonychia included multicolor (101, 68.2%), non-longitudinal homogenous pigmentation (75, 50.7%) and longitudinal white or yellow streaks (52, 31.5%).
UNASSIGNED: This study highlights the commonly identified dermoscopic features of onychomycosis. Recognizing such characteristic dermoscopic features of onychomycosis can assist clinicians diagnose onychomycosis by the bedside.

Onychomycosis is the most common nail disease encountered in clinical practice and can cause pain, difficulty with ambulation, and psycho-social problems. A thorough history and physical examination, including dermoscopy, should be performed for each patient presenting with nail findings suggestive of onychomycosis. Several approaches are available for definitive diagnostic testing, including potassium hydroxide and microscopy, fungal culture, histopathology, polymerase chain reaction, or a combination of techniques. Confirmatory testing should be performed for each patient prior to initiating any antifungal therapies. There are several different therapeutic options available, including oral and topical medications as well as device-based treatments. Oral antifungals are generally recommended for moderate to severe onychomycosis and have higher cure rates, while topical antifungals are recommended for mild to moderate disease and have more favorable safety profiles. Oral terbinafine, itraconazole, and griseofulvin and topical ciclopirox 8% nail lacquer, efinaconazole 10% solution, and tavaborole 5% solution are approved by the Food and Drug Administration for treatment of onychomycosis in the United States and amorolfine 5% nail lacquer is approved in Europe. Laser treatment is approved in the United States for temporary increases in clear nail, but clinical results are suboptimal. Oral fluconazole is not approved in the United States for onychomycosis treatment, but is frequently used off-label with good efficacy. Several novel oral, topical, and over-the-counter therapies are currently under investigation. Physicians should consider the disease severity, infecting pathogen, medication safety, efficacy and cost, and patient age, comorbidities, medication history, and likelihood of compliance when determining management plans. Onychomycosis is a chronic disease with high recurrence rates and patients should be counseled on an appropriate plan to minimize recurrence risk following effective antifungal therapy.

Onychomycosis is the most common nail disease encountered in clinical practice. Its importance extends well beyond aesthetics, often causing pain, difficulty with ambulation and performing daily activities, and impairing quality of life. Many patients fail to achieve cure with antifungal monotherapy and recurrences are common. Combination therapy has therefore gained considerable interest, given the potential for drug synergy and prevention of antifungal resistance, but it has not been well studied. A systematic review of onychomycosis medication only, as well as medication and procedural (laser, debridement, photodynamic therapy), clinical or randomized controlled trials evaluating combination vs. monotherapies was performed. After exclusions, 30 studies were included in the final analysis. There were conflicting results for medication-only trials, with some showing significant benefit of combination therapy over monotherapy, however, trials were not robustly designed and lacked sufficient follow-up. Procedural studies also lacked long-term follow-up, and failed to demonstrate efficacy in some severe onychomycosis cases. Considering the high cure rates demonstrated in pivotal antifungal monotherapy trials, and conflicting results, costs, and safety concerns associated with combination therapy, we recommend that combination therapy be reserved as second-line treatment options in patients with poor prognostic factors or for those who failed monotherapy for onychomycosis.

BACKGROUND: Onychomycosis affects approximately 5% of the population worldwide without satisfactory treatment options regarding efficacy and safety. The aim of this first in human study was to compare the safety and efficacy of the novel compound Mycosinate® against an approved toenail lacquer containing 5% Amorolfine.
METHODS: A randomized, single-blinded, controlled parallel group study with allocation concealment was carried out.
METHODS: Thirty-eight participants either used the novel compound Mycosinate® or an approved toenail lacquer containing 5% Amorolfine for topical application in their own homes. Outcome measures included a) % change in area of clear visible toenail, b) mycological cure rate and c) safety assessments.
RESULTS: Statically significant differences for % change in area of clear visible toenail (p<0.05) of 39.8, 40.0 and 70.7 in favour of Mycosinate® were noted at time points 6 weeks, 12 weeks, and 6 months respectively when compared to Amorolfine. No statistically significant differences were noted for mycological cure rates. No adverse events, serious adverse events or deaths occurred for either treatment.
CONCLUSIONS: Mycosinate® is a promising novel topical onychomycosis treatment with high rates of efficacy and excellent safety profile. Further clinical trials are warranted. (EU Clinical Trials Register 2018/000294/78).

Onychomycosis is the most common nail condition seen in clinical practice, with significant impact on quality of life. Clinical examination alone is insufficient for accurate diagnosis, but mycological confirmation can be challenging during the COVID-19 pandemic. In this letter, a multidisciplinary panel of dermatologists, a podiatrist, dermatopathologists, and a mycologist, discuss considerations for mycological sampling during the pandemic.