Phase 2
N=47
Safety and Efficacy of NVXT Solution in Mild-to-Moderate Fungal Infection of the Toe Nail
Onychomycosis
Bottom Line
View on ClinicalTrials.gov: NCT02343627 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Number of Participants With Negative Fungal Culture — 14; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- NVXT Solution (Drug); Vehicle of test product (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sun Pharmaceutical Industries, Inc.
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Negative Fungal Culture |
14; 2 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02343627). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.