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

NCT ID: NCT02343627

Last Updated: 2018-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-01-31

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.

Conditions

Onychomycosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

NVXT Solution

NVXT Solution once daily for 60 days

Group Type: EXPERIMENTAL

NVXT Solution

Intervention Type: DRUG

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

Vehicle of test product

Vehicle of test product, once daily for 60 days

Group Type: PLACEBO_COMPARATOR

Vehicle of test product

Intervention Type: DRUG

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

Interventions

NVXT Solution

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

NVXT; Placebo

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Pharmaceutical Industries, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Taro Pharmaceuticals USA

Role: STUDY_DIRECTOR

Taro Pharmaceuticals USA Inc.

Other Identifiers

NVXT 1405

Identifier Type: -

Identifier Source: org_study_id