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

August 21, 2018 updated by: Taro Pharmaceuticals USA

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NVXT Solution
NVXT Solution once daily for 60 days
Drug: NVXT Solution
NVXT Solution, applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days.
Other Names:
  • NVXT
Placebo Comparator: Vehicle of test product
Vehicle of test product, 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.
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taro Pharmaceuticals USA

Investigators

  • Study Director: Taro Pharmaceuticals USA, Taro Pharmaceuticals USA Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

December 27, 2014

First Submitted That Met QC Criteria

January 21, 2015

First Posted (Estimate)

January 22, 2015

Study Record Updates

Last Update Posted (Actual)

September 19, 2018

Last Update Submitted That Met QC Criteria

August 21, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NVXT 1405

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Onychomycosis

Clinical Trials on NVXT Solution

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe