In vitro efficacy of tavaborole topical solution, 5% after penetration through nail polish on ex vivo human fingernails

This document is the Accepted Manuscript of the following article: Aditya K. Gupta, et al, 'In vitro efficacy of tavaborole topical solution, 5% after penetration through nail polish on ex vivo human fingernails', Journal of Dermatological Treatment, Jan 2018. Under embargo until 10 January 2019. The final, published version is available online at doi: https://doi.org/10.1080/09546634.2017.1422078.Background: Topical antifungal treatments for onychomycosis are applied to clean, unpolished nails for 48 weeks or longer. Patients often wish to mask their infection with nail polish yet there is no evidence to suggest antifungal efficacy in the presence of nail polish. Objective: To determine if tavaborole retains the ability to penetrate the nail plate and inhibit fungal growth in the presence of nail polish. Method: Tavaborole was applied to human fingernails painted with 2 or 4 coats of nail polish, and unpainted nails in an ex vivo model. Nails were mounted on TurChub ® chambers seeded with Trichophyton rubrum and allowed to incubate for 7 days. Antifungal activity was assessed by measuring zones of inhibition. Results and conclusion: Tavaborole exhibited antifungal activity in all experimental groups. The zones of inhibition of T. rubrum for all experimental groups (2 or 4 coats of polish, unpolished) were greater than infected controls (polished and unpolished), p s <.001. Tavaborole penetrates polished nails and kills T. rubrum in this ex vivo model.Peer reviewe

Perceptions of the Podiatric Medicine Profession: A Survey of Medical Students in Philadelphia, Pennsylvania.

BACKGROUND: Medical students (MSs) in allopathic and osteopathic medical programs may not be adequately exposed to the role of podiatric physicians and surgeons in health care. We explored perceptions of the specialty field of podiatric medicine from the perspective of MSs in the Philadelphia, Pennsylvania, area. METHODS: In this cross-sectional survey study, responses regarding podiatric education and scope of practice were collected via a 16-question, self-reported, anonymous online survey distributed to MSs at one osteopathic and three allopathic medical schools in the Philadelphia area. Inferences and conclusions were drawn from the percentages of respondents. Statistical analyses for school of attendance, year of study, and physician relative subgroups were performed. RESULTS: The 129 survey responses obtained revealed misunderstandings regarding podiatric education and training. Only 45.7% correctly answered that podiatric medical students do not take the United States Medical Licensing Examination. The results also showed the perception of podiatry in a positive light, with approximately 80% of respondents agreeing that the term doctor is applicable when referring to a podiatrist. Respondents with a physician relative were more likely to rate podiatry\u27s role in health care higher on a scale from 0 (inessential) to 5 (equivalent to MDs/DOs) than those without a physician relative. CONCLUSIONS: The results of this preliminary survey were generally positive and optimistic while also identifying some misconceptions regarding MS perceptions of podiatric medical training and scope of practice. Further studies are needed to evaluate perceptions of podiatry from the perspective of other members of the health-care team to improve interprofessional relations and understanding

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

Onychomycosis is a fungal infection, and, as such, one of the goals of treatment should be eradication of the infective agent. Despite this, in contrast to dermatologists, many podiatric physicians do not include antifungals in their onychomycosis treatment plans. Before initiating treatment, confirmation of mycologic status via laboratory testing (eg, microscopy with potassium hydroxide preparation, histopathology with periodic acid-Schiff staining, fungal culture, and polymerase chain reaction) is important; however, more podiatric physicians rely solely on clinical signs than do dermatologists. These dissimilarities may be due, in part, to differences between specialties in training, reimbursement patterns, or practice orientation, and to explore these differences further, a joint podiatric medicine-dermatology roundtable was convened. In addition, treatment options have been limited owing to safety concerns with available oral antifungals and relatively low efficacy with previously available topical treatments. Recently approved topical treatments-efinaconzole and tavaborole-offer additional options for patients with mild-to-moderate disease. Debridement alone has no effect on mycologic status, and it is recommended that it be used in combination with an oral or topical antifungal. There is little to no clinical evidence to support the use of lasers or over-the-counter treatments for onychomycosis. After a patient has achieved cure (absence of clinical signs or absence of fungus with minimal clinical signs), lifestyle and hygiene measures, prophylactic/maintenance treatment, and proactive treatment for tinea pedis, including in family members, may help maintain this status

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

Diagnosis and Management of Onychomycosis Perspectives from a Joint Podiatric Medicine-Dermatology Roundtable

Onychomycosis is a fungal infection, and, as such, one of the goals of treatment should be eradication of the infective agent. Despite this, in contrast to dermatologists, many podiatric physicians do not include antifungals in their onychomycosis treatment plans. Before initiating treatment, confirmation of mycologic status via laboratory testing (eg, microscopy with potassium hydroxide preparation, histopathology with periodic acid-Schiff staining, fungal culture, and polymerase chain reaction) is important; however, more podiatric physicians rely solely on clinical signs than do dermatologists. These dissimilarities may be due, in part, to differences between specialties in training, reimbursement patterns, or practice orientation, and to explore these differences further, a joint podiatric medicine-dermatology roundtable was convened. In addition, treatment options have been limited owing to safety concerns with available oral antifungals and relatively low efficacy with previously available topical treatments. Recently approved topical treatments-efinaconzole and tavaborole-offer additional options for patients with mild-to-moderate disease. Debridement alone has no effect on mycologic status, and it is recommended that it be used in combination with an oral or topical antifungal. There is little to no clinical evidence to support the use of lasers or over-the-counter treatments for onychomycosis. After a patient has achieved cure (absence of clinical signs or absence of fungus with minimal clinical signs), lifestyle and hygiene measures, prophylactic/maintenance treatment, and proactive treatment for tinea pedis, including in family members, may help maintain this status

Disappearing Nail Bed: Review of Etiology, Grading System, and Treatment Options.

Disappearing nail bed (DNB) is a condition characterized by irreversible epithelialization of the nail bed following long-standing onycholysis. This phenomenon can occur in fingernails and toenails. Factors implicated in the development of DNB include trauma, manicuring, and onychotillomania and dermatologic conditions like psoriasis and dermatitis. Specifically for the toenail, contributing factors also include increasing age, history of trauma, surgery, onychomycosis, and onychogryphosis. A grading system that stages the progression of onycholysis to DNB has been proposed to aid clinicians in the diagnosis and treatment of these conditions. Several methods have been designated for the treatment of DNB

Safety, Pharmacokinetics, and Efficacy of Efinaconazole 10% Topical Solution for Onychomycosis Treatment in Pediatric Patients

BACKGROUND: Pediatric onychomycosis management is challenging as there are limited treatment options. The objective of this study was to evaluate efinaconazole 10% topical solution in children with onychomycosis. METHODS: This phase 4, multicenter, open-label study (NCT02812771) evaluated safety, pharmacokinetics (PK), and efficacy of efinaconazole 10% topical solution in pediatric participants (6-16 years). Efinaconazole was administered once daily for 48 weeks, with a 4-week posttreatment follow up. Participants had culture-positive, mild-to-severe distal lateral subungual onychomycosis affecting at least 20% of at least 1 great toenail. The PK subset included participants 12-16 years with moderate-to-severe onychomycosis affecting at least 50% of each great toenail and onychomycosis in at least 4 additional toenails. RESULTS: Of 62 enrolled participants, 60 were included in the safety population and 17 in the PK population. Efinaconazole 10% topical solution was well tolerated. The concentration-time profiles for efinaconazole and its major metabolite were relatively stable, with only minor fluctuations during the 24-hour dosing interval. Systemic exposure to efinaconazole was low. By week 52, 65.0% of participants achieved mycologic cure, with a 36.7% mycologic cure rate observed as early as week 12. A total of 40.0% of participants achieved complete cure, 50.0% achieved clinical efficacy, and 88.3% achieved fungal cure by week 52. CONCLUSION: Efinaconazole was safe and efficacious in pediatric participants with mild-to-severe onychomycosis, with improved mycologic cure and complete cure rates compared with adults from two 52-week studies