Trial Outcomes & Findings for Safety and Efficacy of NVXT Solution in Mild-to-Moderate Fungal Infection of the Toe Nail (NCT NCT02343627)
NCT ID: NCT02343627
Last Updated: 2018-09-19
Results Overview
To assess number of participants with negative fungal culture after repeated once-daily topical applications for 28 days
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
28 days
Results posted on
2018-09-19
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
12
|
|
Overall Study
COMPLETED
|
23
|
11
|
|
Overall Study
NOT COMPLETED
|
12
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of NVXT Solution in Mild-to-Moderate Fungal Infection of the Toe Nail
Baseline characteristics by cohort
| Measure |
NVXT Solution
n=35 Participants
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.
|
Vehicle of Test Product
n=12 Participants
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.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: Subjects with fungal culture collected at the study day 28 visit. The subjects may not complete all study visits.
To assess number of participants with negative fungal culture after repeated once-daily topical applications for 28 days
Outcome measures
| Measure |
NVXT Solution
n=33 Participants
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.
|
Vehicle of Test Product
n=12 Participants
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.
|
|---|---|---|
|
Number of Participants With Negative Fungal Culture
|
14 Participants
|
2 Participants
|
Adverse Events
NVXT Solution
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Vehicle of Test Product
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NVXT Solution
n=35 participants at risk
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.
|
Vehicle of Test Product
n=12 participants at risk
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.
|
|---|---|---|
|
Vascular disorders
Hypertension
|
0.00%
0/35
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.9%
1/35 • Number of events 1
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Common Cold
|
5.7%
2/35 • Number of events 2
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Pharangitis
|
0.00%
0/35
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
2.9%
1/35 • Number of events 1
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
2.9%
1/35 • Number of events 1
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasm
|
0.00%
0/35
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Exacerbation of Tinea Pedis
|
2.9%
1/35 • Number of events 1
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.9%
1/35 • Number of events 1
|
0.00%
0/12
|
Additional Information
Senior Director, Clinical
Taro Pharmaceuticals U.S.A. Inc
Phone: +1 914-345-900
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place