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

Onychomycosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02343627
• Other study ID #: NVXT 1405
• Status: Completed
• Phase: Phase 2
• Start date: December 2014
• Est. completion date: January 2016

Study information

• Verified date: August 2018
• Source: Taro Pharmaceuticals USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Mycoses
• Onychomycosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taro Pharmaceuticals USA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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