NCT02267356

A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Onychomycosis of the Toenail

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of VT-1161 Oral Tablets in the Treatment of Patients With Distal Lateral Subungual Onychomycosis of the Toenail

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 259 (actual)
• Sponsor: Viamet · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Several properties of VT-1161 suggest that it might be a safer and more effective treatment for onychomycosis of the toenail (also known as toenail fungus) than other oral antifungal medicines. This study will evaluate the effectiveness and safety of VT-1161 for the treatment of toenail onychomycosis and consists of a screening phase, a 24-week treatment phase in which the patient will take either active drug, placebo or a combination of the 2 (according to random assignment), an initial observational phase of 36 weeks and an additional observational study extension of 9 months. The additional 9-month observational study extension was added with a protocol amendment and patient participation was optional.

Conditions

• Onychomycosis

Interventions

Type	Name	Description
DRUG	VT-1161
DRUG	Placebo

Timeline

• Start date: 2015-02-17
• Primary completion: 2016-10-18
• Completion: 2017-07-07
• First posted: 2014-10-17
• Last updated: 2020-11-04
• Results posted: 2020-11-04

Locations

33 sites across 1 country: United States