NCT01208168

Safety & Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails

A Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Parallel Group Study of the Safety and Efficacy of NAB001 in the Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenails for 52 Wks

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 468 (actual)
• Sponsor: Promius Pharma, LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are to assess the safety of NAB001 for topical treatment of mild to moderate distal onychomycosis of the toenails over 52 weeks and to compare the efficacy of NAB001 to vehicle alone at the end of the study (Week 56) after treating for 52 weeks.

Conditions

• Onychomycosis

Interventions

Type	Name	Description
DRUG	NAB001	nail lacquer, once daily, 52 weeks
DRUG	Vehicle alone	nail lacquer, once daily, 52 weeks

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2010-09-23
• Last updated: 2013-07-11

Locations

24 sites across 2 countries: United States, Dominican Republic