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  • EDITORS Kenneth A. Arndt, MD Philip E. LeBoit, MD Bruce U. Wintroub, MD


    VOL. 34, NO. 3S

    JUNE 2015

    Managing Onychomycosis: New and Emerging Treatments and

    Recurrence Prevention Strategies


    David M. Pariser, MD, Chair

    Nathaniel J. Jellinek, MD

    Phoebe Rich, MD

    Melodie S. Young, MSN, RN, A/GNP-c

    Introduction S45

    Efficacy and Safety of Onychomycosis Treatments: S46 An Evidence-Based Overview

    Understanding Onychomycosis Treatment: S51 Mechanisms of Action and Formulation

    Management Strategies for Onychomycosis S54 in Special Patient Populations

    Making Strides in Preventing S56 Onychomycosis Recurrence

    Post-Test and Evaluation Form S60


  • Managing Onychomycosis: New and Emerging Treatments and Recurrence Prevention Strategies

    Original Release Date: June 2015 Most Recent Review Date: June 2015 Expiration Date: June 30, 2017 Estimated Time to Complete Activity: 2.5 hours Participants should read the activity information, review the activity in its entirety, and complete the online post-test and evaluation. Upon completing this activity as designed and achieving a passing score on the post-test you will be directed to a Web page that will allow you to receive your certificate of credit via email or you may print it out at that time. The online post-test and evaluation can be accessed at Inquiries may be directed to Global Academy for Medical Education or (973) 290-8225.

    Accreditation Statements Physicians: This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of The University of Louisville and Global Academy for Medical Education, LLC.  The University of Louisville is accredited by the ACCME to provide continuing medical education for physicians. The University of Louisville Office of Continuing Medical Education & Professional Development designates this enduring material for a maximum of 2.5 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Nurses: This program has been approved by the Kentucky Board of Nursing for 3.0 contact hours through the University of Louisville Hospital, provider number 4-0068-7-16-820. The Kentucky Board of Nursing approval of an individual nursing education provider does not constitute endorsement of program content. Participants must complete the entire activity, provide license, and complete the evaluation to receive contact hours.

    Target Audience This educational activity is designed for dermatologists, family practitioners, internists, nurse practitioners, physician assistants, and other clinicians who treat patients with onychomycosis.

    Educational Needs With the introduction of more effective treatments—particularly the recently approved topical agents—clinicians in dermatology as well as other specialties and general primary care have a renewed interest in diagnosing and treating onychomycosis, an infection that is now recognized as clinically important but was once considered largely a cosmetic problem with minimal or no medical implications. However, although efficacy with some treatments is good, the medications must be used consistently and correctly for several months before clinical evidence of improvement appears, and before patients perceive that treatment is working. Treatment options currently approved in the United States for onychomycosis include topical and oral agents, as well as laser therapy. Oral agents must be chosen for their activity against the involved pathogens (dermatophytes, nonder- matophytes, or yeast species, or combination infections). The currently approved systemic agents generally are safe for most patients, but concerns remain with respect to systemic side effects (for example, hepatotoxicity), particularly in pedi- atric patients, the elderly, and others with underlying medical conditions such as diabetes. The three agents currently approved for topical therapy are ciclopirox gel 0.77%, approved in 1999, and efinaconazole 10% topical solution and tavaborole topical solution, 5%, both approved in 2014. Other classes of topical antifungals are being evaluated both here and abroad. Clinicians must be able to effectively and safely use the currently approved agents, and must be prepared to evaluate the emerging data on medications now being investigated. Several laser devices are approved, and other types of lasers as well as other modalities (including photodynamic therapy) are being tested in clinical trials. This supplement focuses on the efficacy and safety of onychomycosis treat- ments, particularly those recently approved, and provides an overview of emerging therapies. Mechanisms of action of drugs and devices also are presented to help clinicians tailor therapy according to individual patient clinical profiles. Management strategies for challenging patient populations are offered, and practical approaches to preventing recurrence are addressed— in particular, strategies for enhancing patient adherence to medication use and avoidance of sources of reinfection.

    Learning Objectives As a result of participating in this activity, participants should be able to: • Explain the benefits of early diagnosis and treatment of onychomycosis and the

    potential sequelae if this infection is untreated or is inadequately treated. • Establish or improve practice protocols for identifying patients with

    onychomycosis, particularly in special populations (for example, the elderly, pediatric patients, immunocompromised patients, patients with psoriasis, and those with diabetes mellitus).

    • Identify the mechanism of action for the currently available therapeutic options, including differences in formulation and associated efficacy, and use this knowledge to more effectively tailor treatment choices to individual patients.

    • Incorporate or enhance monitoring for onychomycosis in patients in special, at-risk, or difficult-to-manage populations (for example, the elderly, pediatric patients, immunocompromised patients, patients with psoriasis, and those with diabetes mellitus).

    • More effectively use currently available oral and topical medications to treat various patient populations.

    • Discuss techniques, including obtaining good culture specimens, that permit more accurate diagnosis of the infecting organisms and the most appropriate choice of therapy.

    • Review and, if necessary, improve patient education materials and teaching plans regarding the patient’s role in the treatment of onychomycosis and the prevention of recurrence to increase the chances of effective long-term management of this disease.

    • Evaluate the results of clinical studies on new and emerging and available treatments for onychomycosis.

    Disclosure Declarations As a provider accredited by the ACCME, the Office of CME & PD, School of Medicine, University of Louisville must ensure balance, independence, objectivity, and scien- tific rigor in all its sponsored educational activities. All planners, faculty, reviewers, and other persons that affected the content of this CME activity were required to submit a financial disclosure form from which relevant conflicts of interest were determined. The persons below disclosed the following:

    David M. Pariser, MD, Consultant: Anacor Pharmaceuticals, Inc., DUSA Pharmaceuticals, Inc., LEO Pharma Inc., and Valeant Pharmaceuticals North America LLC. Nathaniel J. Jellinek, MD, Advisory Board: Valeant Pharmaceuticals. Phoebe Rich, MD, Grant/Research: Anacor, Meiji Seika Pharma Co., Ltd., Topica Pharmaceuticals, Inc., and Valeant Pharmaceuticals. Melodie S. Young, MSN, RN, A/GNP-c, has no relevant financial relationships to disclose. CME Reviewer: Cindy England Owen, MD, Assistant Professor, Division of Dermatology, University of Louisville School of Medicine, has no relevant financial relationships to disclose. The CME & PD Staff and Advisory Board have nothing to disclose with the exception of Dr. Douglas Coldwell, Speaker: Sirtex, Inc. and Consultant: DFine, Inc. Global Academy for Medical Education Staff: Sylvia H. Reitman, MBA, DipEd; Shirley V. Jones, MBA; and Joanne Still, BA have no relevant financial relation- ships to disclose.

    Off-Label/Investigational Use Disclosure This CME/CE activity discusses the off-label use of fluconazole for the treatment of onychomycosis and unapproved dosing schedules for itraconazole and terbinafine. Also discussed is the use in pediatric patients of medications approved for the treatment of onychomycosis in adults; currently, no medication is approved for the treatment of onychomycosis in pediatric patients.

    This continuing education supplement was developed from interviews with the faculty. The Guest Editors acknowledge the editorial assistance of Global Academy for Medical Education and Joanne Still, medical writer, in the development of this supplement. The manuscript was reviewed and approved by the Guest Editors as well as the Editors of Seminars in Cutaneous Medicine and Surgery. The ideas and opinions expressed in this supplement are those of the Guest Editors and do not necessarily reflect the views of the supporters, Global Academy for Medical Education, the University of Louisville, or the Publisher.

    Supported by an educational grant from Valeant Pharmaceuticals North America LLC.

    Jointly provided by



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