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A Closer Look at a Topical Antifungal for Onychomycosis
This coverage is supported by Ortho Dermatologics.
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Onychomycosis is a fungal infection that warrants intervention, and not just a condition of the toenail, Warren Joseph, DPM, FIDSA, emphasized at a lunch symposium at this year's APMA National.
“This is an infectious disease and as an infectious disease, we need to treat it with an antifungal,” stressed Dr. Joseph. “We don’t hesitate to treat a bacterial infection with an antibacterial—why would we hesitate to treat onychomycosis with an antifungal?”
Efinaconazole (Jublia, Ortho Dermatologics) is a topical indicated for onychomycosis of the toenail due to Trichophyton rubrum and Trichophyton mentagrophytes. Dr. Joseph said the antifungal is formulated with a vehicle that passes through to the subungual space to distribute below the nail plate.
Efinaconazole, a triazole antifungal, is formulated to reach the site of the infection. Dr. Joseph noted that efinaconazole is low keratin binding and hydrophilic. He added that as an alcohol-based formulation, efinaconazole dries quickly, and it has a low surface tension, allowing it to get under the nail.
Dr. Joseph cited two phase III multicenter, randomized, double-blind studies of efinaconazole versus vehicle in a total of 1665 patients.1 The study found mycologic cure rates to be significantly greater with efinaconazole (study 1: 55.2%, study 2: 53.4%) compared with vehicle. In addition, the primary end point—complete cure—was significantly better in efinaconazole patients (study 1: 17.8% vs 3.3%, study 2: 15.2% vs 5.5%).
One in three patients with diabetes will develop onychomycosis, said Dr. Joseph, and onychomycosis in patients with diabetes puts patients at greater risk for amputation and secondary bacterial infection, noted Dr. Joseph. How effective is efinaconazole in that patient population? He noted a study found no statistically significant difference in efinaconazole in patients with or without diabetes.2
What about pediatric patients with onychomycosis? Dr. Joseph said a study 60 children ages 6–16 found a complete cure rate of 40% and a mycological cure rate of 65% at 52 weeks.3
Efinaconazole also penetrates through nail polish, with studies noting two coats did not inhibit the efficacy of the antifungal, and that nail polish maintained its appearance through five applications.4
References
1. Elewski BE, Rich P, Pollak R, et al. Efinaconazole 10% solution in the treatment of toenail onychomycosis: Two phase III multicenter, randomized, double-blind studies. J Am Acad Dermatol. 2013 Apr;68(4):600-608. doi: 10.1016/j.jaad.2012.10.013. Epub 2012 Nov 20. Erratum in: J Am Acad Dermatol. 2014 Feb;70(2):399. PMID: 23177180.
2. Vlahovic TC, Joseph WS. Efinaconazole topical, 10% for the treatment of toenail onychomycosis in patients with diabetes. J Drugs Dermatol. 2014;13(10):1186-1190.
3. Data on file.
4. Zeichner JA, Stein Gold L, Korotzer A. Penetration of ((14)C)-efinaconazole topical solution, 10%, does not appear to be influenced by nail polish. J Clin Aesthet Dermatol. 2014 Sep;7(9):34-6. Erratum in: J Clin Aesthet Dermatol. 2014 Nov;7(11):8. PMID: 25276275; PMCID: PMC4174918.
