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

Primary Purpose

Onychomycosis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
NVXT Solution
Vehicle of test product
Sponsored by
Taro Pharmaceuticals USA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Onychomycosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    NVXT Solution

    Vehicle of test product

    Arm Description

    NVXT Solution once daily for 60 days

    Vehicle of test product, once daily for 60 days

    Outcomes

    Primary Outcome Measures

    Number of Participants With Negative Fungal Culture
    To assess number of participants with negative fungal culture after repeated once-daily topical applications for 28 days

    Secondary Outcome Measures

    Full Information

    First Posted
    December 27, 2014
    Last Updated
    August 21, 2018
    Sponsor
    Taro Pharmaceuticals USA
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02343627
    Brief Title
    Safety and Efficacy of NVXT Solution in Mild-to-Moderate Fungal Infection of the Toe Nail
    Official 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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2014 (undefined)
    Primary Completion Date
    January 2016 (Actual)
    Study Completion Date
    January 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Taro Pharmaceuticals USA

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Onychomycosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    47 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    NVXT Solution
    Arm Type
    Experimental
    Arm Description
    NVXT Solution once daily for 60 days
    Arm Title
    Vehicle of test product
    Arm Type
    Placebo Comparator
    Arm Description
    Vehicle of test product, once daily for 60 days
    Intervention Type
    Drug
    Intervention Name(s)
    NVXT Solution
    Other Intervention Name(s)
    NVXT
    Intervention Description
    NVXT Solution, applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days.
    Intervention Type
    Drug
    Intervention Name(s)
    Vehicle of test product
    Other Intervention Name(s)
    Placebo
    Intervention Description
    Vehicle of test product applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days.
    Primary Outcome Measure Information:
    Title
    Number of Participants With Negative Fungal Culture
    Description
    To assess number of participants with negative fungal culture after repeated once-daily topical applications for 28 days
    Time Frame
    28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Taro Pharmaceuticals USA
    Organizational Affiliation
    Taro Pharmaceuticals USA Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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