NCT02343627

Safety and Efficacy of NVXT Solution in Mild-to-Moderate Fungal Infection of the Toe Nail

A Randomized, Double-Blind, Placebo-Controlled, Pilot Study to Assess the Safety and Efficacy of NVXT Solution in Patients With Mild-to-Moderate Fungal Infection of the Toe Nail

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will examine the safety, tolerability and efficacy of NVXT in a new formulation in patients with mild-to-moderate fungal infection of the toe nail.

Detailed description

This Phase IIa pilot multiple-dose study will examine the safety, tolerability and efficacy of NVXT in a new formulation in patients with mild-to-moderate fungal infection of the toe nail.

Conditions

• Onychomycosis

Interventions

Type	Name	Description
DRUG	NVXT Solution	NVXT Solution, applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days.
DRUG	Vehicle of test product	Vehicle of test product applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days.

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2015-01-22
• Last updated: 2018-09-19
• Results posted: 2018-08-22