NCT02812771

Safety and Pharmacokinetics of Efinaconazole Topical Solution in Subjects With Mild to Severe Onychomycosis

A Multicenter, Open Label, Single-arm Study Evaluating the Safety and Pharmacokinetics of Efinaconazole Topical Solution in Subjects With Mild to Severe Onychomycosis of the Toenails

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 6 Years – 16 Years
• Healthy volunteers: Accepted

Summary

Safety and Pharmacokinetics (PK) of a once daily topical application of efinaconazole in the treatment of pediatric subjects with mild to severe onychomycosis of the toenails.

Detailed description

This is an open label, single-arm study designed to evaluate the safety and PK of a once daily topical application of efinaconazole in the treatment of pediatric subjects with mild to severe onychomycosis of the toenails.

Conditions

• Onychomycosis

Interventions

Type	Name	Description
DRUG	Efinaconazole	Solution

Timeline

• Start date: 2016-08-04
• Primary completion: 2019-01-14
• Completion: 2019-01-14
• First posted: 2016-06-24
• Last updated: 2021-11-01
• Results posted: 2021-11-01

Locations

10 sites across 2 countries: United States, Dominican Republic