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

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.

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