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Completed

NCT Number: NCT02343627

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

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.

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Key information

Conditions

Onychomycosis Bacterial Infections and Mycoses Dermatomycoses Infections Mycoses Nail Diseases Skin Diseases Skin Diseases, Infectious Skin and Connective Tissue Diseases Tinea

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinically diagnosed onychomycosis
  • Presence of dermatophyte fungal infection with no current topical or systemic antifungal therapy
  • Clinical diagnosis of mild-to-moderate fungal infection of at least one toe involving 10-50% of the nail area, without involvement of one of the lunular proximal regions
  • Positive potassium hydroxide mount preparation
  • Positive fungal culture for a dermatophyte

Exclusion criteria

  • Nail or anatomical abnormalities of the toe that may interfere with evaluations or dosing compliance

Treatment and study plan

NVXT Solution

Drug

NVXT Solution, applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days.

Other names: NVXT

Vehicle of test product

Drug

Vehicle of test product applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days.

Other names: Placebo

Primary outcomes

  1. Number of Participants With Negative Fungal Culture

    Time frame: 28 days

    To assess number of participants with negative fungal culture after repeated once-daily topical applications for 28 days

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 22, 2015
Registry last updated
Sep 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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