Clinical Trial: Safety and Pharmacokinetics of Efinaconazole Topical Solution in Subjects With Mild to Severe Onychomycosis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: 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
Brief Summary: 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.
Detailed Summary: 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.
Sponsor: Valeant Pharmaceuticals International, Inc.
Current Primary Outcome: Adverse Events will be collected as spontaneous reports by the subjects and as observations by the investigators. . [ Time Frame: 48 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Valeant Pharmaceuticals International, Inc.
Dates:
Date Received: June 22, 2016
Date Started: June 2016
Date Completion: February 2018
Last Updated: April 5, 2017
Last Verified: April 2017