JUBLIA (Efinaconazole 10% Solution) in the Treatment of Pediatric Onychomycosis.

ABSTRACT

Onychomycosis is a chronic fungal infection of the nails and is commonly observed in adults, especially the elderly, those who are diabetic, have poor peripheral circulation, and are immunocompromised; however, onychomycosis in children is being reported more frequently, especially in older children. There could also be a genetic predisposition to developing onychomycosis. Given that onychomycosis is uncommon in children, it is important to confirm the diagnosis mycologically. Treatment of onychomycosis includes oral or topical antifungal agents. In North America, the available oral antifungal agents are terbinafine, itraconazole, and fluconazole; however, none of these agents are approved by Food and Drug Administration (FDA) for children with onychomycosis. Terbinafine is, however, approved for tinea capitis in children aged 4 years and older. In general, these oral agents have been found to be safe and effective for pediatric onychomycosis. The available topical agents are efinaconazole solution 10%, tavaborole solution 5%, and ciclopirox nail lacquer topical solution 8%. The former two are approved by the FDA for the treatment of pediatric onychomycosis in children aged 6 years and older, while the third one is approved in children over the age of 12 years who have onychomycosis. In a phase-IV, multicenter, open label study, efinaconazole solution 10% was administered to children aged 6-16 years with culture positive, mild-to-severe distal and lateral subungual onychomycosis affecting ≥20% of at least one great toenail. Treatment was for 48 weeks, with follow-up at week 52. Efinaconazole solution 10% was found to be safe and well tolerated in this pediatric population. By week 52, the mycological cure was 65%, and the complete cure was 40%. The topical agents could be an important addition to the armamentarium of therapies available to treat pediatric onychomycosis safely and effectively.