Safety and Efficacy of NVXT Solution in Mild-to-Moderate Fungal Infection of the Toe Nail
Phase 2
Completed
- Conditions
- Onychomycosis
- Interventions
- Drug: Vehicle of test product
- Registration Number
- NCT02343627
- Lead Sponsor
- Taro Pharmaceuticals USA
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NVXT Solution NVXT Solution NVXT Solution once daily for 60 days Vehicle of test product Vehicle of test product Vehicle of test product, once daily for 60 days
- Primary Outcome Measures
Name Time Method Number of Participants With Negative Fungal Culture 28 days To assess number of participants with negative fungal culture after repeated once-daily topical applications for 28 days
- Secondary Outcome Measures
Name Time Method