NCT02343627CompletedPhase 2
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Taro Pharmaceuticals USA
- Enrollment
- 47
- Primary Endpoint
- Number of Participants With Negative Fungal Culture
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
NVXT Solution
Experimental
NVXT Solution once daily for 60 days
Intervention: NVXT Solution (Drug)
Vehicle of test product
Placebo Comparator
Vehicle of test product, once daily for 60 days
Intervention: Vehicle of test product (Drug)
Outcomes
Primary Outcomes
Number of Participants With Negative Fungal Culture
Time Frame: 28 days
To assess number of participants with negative fungal culture after repeated once-daily topical applications for 28 days
Secondary Outcomes
No secondary outcomes reported
Investigators
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