Efinaconazole 10% topical solution is safe and effective for pediatric patients with onychomycosis, according to the findings of a recent study.
“Pediatric onychomycosis management is challenging as there are limited treatment options,” the researchers wrote. In a phase 4, multicenter, open-label study, they evaluated the safety, efficacy, and pharmacokinetics (PK) of efinaconazole 10% topical solution among 62 pediatric participants aged 6 to 16 years. All participants had culture-positive, mild to severe distal lateral subungual onychomycosis affecting at least 20% of at least 1 great toenail. They were treated with efinaconazole 10% topical solution once a day for 48 weeks and followed for an additional 4 weeks after the treatment ended.
The PK analysis included a subgroup of 17 participants aged 12 to 16 years with moderate to severe onychomycosis affecting at least 50% of each great toenail and onychomycosis in at least 4 additional toenails.
The researchers found efinaconazole 10% topical solution was well tolerated among the 60 participants included in the safety population. Systemic exposure was low, and the concentration-time profiles and major metabolite of efinaconazole were relatively stable, with only minor fluctuations during the 24-hour dosing interval, they said.
At week 52, the researchers found 65% of participants achieved mycologic cure, with a mycologic cure rate of 36.7% seen as early as week 12. In addition, 40% of participants achieved complete cure, 50% achieved clinical efficacy, and 88.3% achieved fungal cure by week 52.
“Efinaconazole was safe and efficacious in pediatric participants with mild-to-severe onychomycosis, with improved mycologic cure and complete cure rates compared with adults from two 52-week studies,” the researchers concluded.
Eichenfield LF, Elewski B, Sugarman JL, et al. Safety, pharmacokinetics, and efficacy of efinaconazole 10% topical solution for onychomycosis treatment in pediatric patients. J Drugs Dermatol. 2020;19(9):867-872. doi:10.36849/JDD.2020.5401