Labeled use of efinaconazole topical solution 10% in treating onychomycosis in children and a review of the management of pediatric onychomycosis

Abstract

Background: Until recently, there was no FDA‐approved antifungal treatment for onychomycosis in children. There is evidence regarding the safety and efficacy of topical antifungal agents for pediatric onychomycosis. Objective: To summarize the results of a recent study using efinaconazole 10% solution to treat onychomycosis in children and discuss the management of pediatric onychomycosis. Methods: In a multicenter, open‐label phase 4 study, efinaconazole 10% solution was applied once daily in children aged 6‐16 years with mild to severe, culture positive, distal and lateral subungual onychomycosis. Treatment was for 48 weeks with a follow‐up at week 52. Pharmacokinetics was performed in a subset of patients. Results: There were 62 patients enrolled in the study. At week 52 the mycological cure rate was 65% and complete cure rate was 40%. All treatment‐emergent adverse events (TEAE) were mild to moderate in severity with none resulting in study discontinuation. Efinaconazole was detected at low levels in plasma. Conclusions: Efinaconazole topical solution 10% is effective and safe in treating onychomycosis in children age 6‐16 years and was recently FDA‐approved for this indication. The off‐label use of other topical agents, tavaborole solution 5% and ciclopirox nail lacquer solution 8%, and oral agents in pediatric onychomycosis is reviewed.