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

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taro Pharmaceuticals USA
• Treatments: Pharmaceutical Solutions

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