Onychomycosis
Conditions
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.
Interventions
DRUGNVXT Solution
NVXT Solution, applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days.
Vehicle of test product applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days.
Sponsors
Sun Pharmaceutical Industries, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NVXT Solution NVXT Solution once daily for 60 days
NVXT Solution: NVXT Solution, applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days. | 35 |
| Vehicle of Test Product Vehicle of test product, once daily for 60 days
Vehicle of test product: Vehicle of test product applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days. | 12 |
| Total | 47 |
Baseline characteristics
| Characteristic | NVXT Solution | Vehicle of Test Product | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants | 12 Participants | 47 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 5 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 21 Participants | 5 Participants | 26 Participants |
| Sex: Female, Male Female | 5 Participants | 1 Participants | 6 Participants |
| Sex: Female, Male Male | 30 Participants | 11 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 35 | 3 / 12 |
| serious Total, serious adverse events | 0 / 35 | 0 / 12 |
Outcome results
Primary
Number of Participants With Negative Fungal Culture
To assess number of participants with negative fungal culture after repeated once-daily topical applications for 28 days
Time frame: 28 days
Population: Subjects with fungal culture collected at the study day 28 visit. The subjects may not complete all study visits.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NVXT Solution | Number of Participants With Negative Fungal Culture | 14 Participants |
| Vehicle of Test Product | Number of Participants With Negative Fungal Culture | 2 Participants |