resistance. Combination treatment may also be synergistic; an in vitro study found that efinaconazole in combination with an oral drug was the most advantageous,39 though clinical studies are needed to confirm these results.
Treatment failure, recurrence, and maintenance
If a patient fails pharmaceutical treatment, reassess and retest to confirm initial diagnosis (Figure 3). Slightly different approaches are recommended in the event of treatment failure with an oral versus a topical. For terbinafine, a sample can be sent for susceptibility testing after one month off terbinafine; if minimum inhibitory concentration (MIC) is high, switch to fluconazole with or without a topical (treatment may need to be adjusted based on strain susceptibility). Since not all labs perform MIC testing, it is best to confirm test availability in advance. For topical treatment failure, consider adjunctive debridement or add an oral medication. To prevent recurrence: topical antifungal creams could be added; booster/pulsed dosing or extended dosing with an oral may be beneficial—particularly in older patients (tailor treatment duration to the patient); a topical such as efinaconazole can also be regularly applied after an oral regimen as maintenance treatment (off-label treatment ranging from once weekly to once daily; Figure 3). Though scientific evidence on topical maintenance treatments is limited, pharmaceutical treatment may be needed indefinitely to prevent recurrence. In case of recurrence with a topical or oral, give a second course of initial treatment.
Patient Education
It is important to manage patient expectations when treating onychomycosis. Toenails grow slowly, meaning optimal results can take 12–18 months.40 Further, patients should be made aware that even after treatment they may never achieve a normal looking nail if there is toenail loss or they have a disappearing nail bed. Finally, clinical cure may not be possible, particularly in those with very long-term disease; in these patients an improved, better looking nail may be acceptable.
Another issue requiring patient education is the high recurrence rates of onychomycosis (6.5%–53%),5 especially in athletes, older patients, or patients with long-term disease, diabetes, peripheral vascular disease, or a genetic predisposition.5,41 It is recommended that physicians schedule follow-up visits 3–6 months after oral medications or one year after topical to check for recurrence and determine if treatment should be resumed or changed. Furthermore, a physical handout (see Figure 5) should be provided explaining follow-up care and maintenance, highlighting that long-term treatment is more than just pharmacologic (eg, personal care, footwear selection/ care, laundry42). Patients should be advised to use an ultraviolet shoe sanitizer and/or copper or silver socks.43 Antifungal powder added to shoes is also an option, although research regarding its efficacy is lacking.
For pediatric patients, parents or guardians should be asked to apply any topical treatment daily to ensure adherence. All family members should be checked for onychomycosis and tinea pedis and counseled regarding treatment and prevention.
Treatment failure, recurrence, and maintenance
If a patient fails pharmaceutical treatment, reassess and retest to confirm initial diagnosis (Figure 3). Slightly different approaches are recommended in the event of treatment failure with an oral versus a topical. For terbinafine, a sample can be sent for susceptibility testing after one month off terbinafine; if minimum inhibitory concentration (MIC) is high, switch to fluconazole with or without a topical (treatment may need to be adjusted based on strain susceptibility). Since not all labs perform MIC testing, it is best to confirm test availability in advance. For topical treatment failure, consider adjunctive debridement or add an oral medication. To prevent recurrence: topical antifungal creams could be added; booster/pulsed dosing or extended dosing with an oral may be beneficial—particularly in older patients (tailor treatment duration to the patient); a topical such as efinaconazole can also be regularly applied after an oral regimen as maintenance treatment (off-label treatment ranging from once weekly to once daily; Figure 3). Though scientific evidence on topical maintenance treatments is limited, pharmaceutical treatment may be needed indefinitely to prevent recurrence. In case of recurrence with a topical or oral, give a second course of initial treatment.
Patient Education
It is important to manage patient expectations when treating onychomycosis. Toenails grow slowly, meaning optimal results can take 12–18 months.40 Further, patients should be made aware that even after treatment they may never achieve a normal looking nail if there is toenail loss or they have a disappearing nail bed. Finally, clinical cure may not be possible, particularly in those with very long-term disease; in these patients an improved, better looking nail may be acceptable.
Another issue requiring patient education is the high recurrence rates of onychomycosis (6.5%–53%),5 especially in athletes, older patients, or patients with long-term disease, diabetes, peripheral vascular disease, or a genetic predisposition.5,41 It is recommended that physicians schedule follow-up visits 3–6 months after oral medications or one year after topical to check for recurrence and determine if treatment should be resumed or changed. Furthermore, a physical handout (see Figure 5) should be provided explaining follow-up care and maintenance, highlighting that long-term treatment is more than just pharmacologic (eg, personal care, footwear selection/ care, laundry42). Patients should be advised to use an ultraviolet shoe sanitizer and/or copper or silver socks.43 Antifungal powder added to shoes is also an option, although research regarding its efficacy is lacking.
For pediatric patients, parents or guardians should be asked to apply any topical treatment daily to ensure adherence. All family members should be checked for onychomycosis and tinea pedis and counseled regarding treatment and prevention.
CONCLUSION
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. 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. Efinaconazole can be used for maintenance to prevent
recurrence. For optimal outcomes, patients should be counseled
regarding treatment expectations as well as follow-up care and
maintenance post-treatment.
DISCLOSURES
Shari R. Lipner has served a consultant for Ortho Dermatologics,
Hoth Therapeutics, and Verrica. Warren S. Joseph has served
as consultant and speaker for Ortho Dermatologics. Tracey
C. Vlahovic has served as investigator and speaker for Ortho
Dermatologics. Richard K. Scher has nothing to disclose. Phoebe
Rich has received research and educational grants from AbbVie,
Allergan, Anacor Pharmaceuticals, Boehringer Ingelheim,
Cassiopea, Dermira, Eli Lilly, Galderma, Janssen Ortho Inc.,
Kadmon Corporation, LEO Pharma, Merck, Moberg Derma,
Novartis, Pfizer, Ranbaxy Laboratories Limited, Sandoz, Viamet
Pharmaceutical Inc., Innovation Pharmaceuticals (Cellceutix),
and Cutanea Life Sciences. Mahmoud Ghannoum has acted as
a consultant or received contracts from Scynexis, Inc, Bausch &
Lomb, Pfizer, and Mycovia. C. Ralph Daniel has provided clinical
research support to Ortho Dermatologics and owns stock in
Medimetriks Pharmaceuticals. Boni Elewski has provided clinical
research support (research funding to University) for AbbVie,
Anaptys-Bio, Boehringer Ingelheim, Bristol-Myers Squibb,
Celgene, Incyte, LEO Pharma, Lilly, Merck, Menlo, Novartis,
Pfizer, Regeneron, Sun Pharma, Ortho Dermatologics, Vanda;
and as consultant (received honorarium) from Boehringer
Ingelheim, Bristol Meyers Squibb, Celgene, LEO Pharma, Lilly,
Menlo, Novartis, Pfizer, Sun Pharma, Ortho Dermatologics,
Verrica.
ACKNOWLEDGMENT
Medical writing support was provided by Lynn M. Anderson,
PhD and Jacqueline Benjamin, PhD of Prescott Medical
Communications Group (Chicago, IL), with financial support
from Ortho Dermatologics. Ortho Dermatologics is a division of
Bausch Health US, LLC.
