An Evaluation of the Safety and Pharmacokinetics of Tavaborole Topical Solution for the Treatment of Fungal Disease of the Toenail in Children and Adolescents
Completed
Pfizer
Phase 4
2015-10-22
This was an open-label study to evaluate the safety and pharmacokinetics of tavaborole 5%
topical solution in treating distal subungual onychomycosis (a fungal infection) of the
toenail in children and adolescents (ages 6 to 16 years).
Following confirmation of eligibility, including laboratory evidence of a fungal organism in
the toenail, tavaborole topical solution was applied once daily to all affected toenails for
a 48-week treatment period.
Clinical assessment of the extent of infection and safety assessments were performed
periodically throughout the 48-week treatment period, and again at 52 weeks (4 weeks after
stopping the treatment).
A subgroup of enrolled subjects applied the topical solution to all 10 toenails and a small
area of surrounding skin during the first 28 days. These subjects had blood samples analyzed
to evaluate the pharmacokinetics (how the drug moves in the body) of tavaborole topical
solution in children and adolescents.
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