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
1 other identifier
interventional
47
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2014
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 27, 2014
CompletedFirst Posted
Study publicly available on registry
January 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedResults Posted
Study results publicly available
August 22, 2018
CompletedSeptember 19, 2018
August 1, 2018
1.1 years
December 27, 2014
May 17, 2018
August 21, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
28 days
Study Arms (2)
NVXT Solution
EXPERIMENTALNVXT Solution once daily for 60 days
Vehicle of test product
PLACEBO COMPARATORVehicle of test product, once daily for 60 days
Interventions
NVXT Solution, applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days.
Vehicle of test product applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Nail or anatomical abnormalities of the toe that may interfere with evaluations or dosing compliance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director, Clinical
- Organization
- Taro Pharmaceuticals U.S.A. Inc
Study Officials
- STUDY DIRECTOR
Taro Pharmaceuticals USA
Taro Pharmaceuticals USA Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 27, 2014
First Posted
January 22, 2015
Study Start
December 1, 2014
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
September 19, 2018
Results First Posted
August 22, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share