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

Sun Pharmaceutical Industries, Inc.47 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Onychomycosis

Interventions

NVXT SolutionDRUG

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

Vehicle of test productDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 28 days

Data from ClinicalTrials.gov

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