Safety and Efficacy of NVXT Solution in Mild-to-Moderate Fungal Infection of the Toe Nail
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Infectious Disease, Podiatry |
| Therapuetic Areas: | Immunology / Infectious Diseases, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | December 2014 |
| End Date: | January 2016 |
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.
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.
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
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