Onychomycosis
Conditions
Brief summary
A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi- Site Phase 2b Clinical Study to Assess the Efficacy, Safety and Tolerability of 8-Week Regimens of NVXT topical product in Patients with Mild to Moderate Onychomycosis
Detailed description
Evaluate safety and tolerability of the two regimens of NVXT (Treatment Groups A and B) in patients with mild to moderate distal subungual onychomycosis of the target toenail.
Interventions
DRUGNVXT topical
topical treatment
DRUGPlacebo (Vehicle) Topical
Placebo (Vehicle) Topical
Sponsors
Sun Pharmaceutical Industries, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Clinical diagnosis of onychomycosis of the target toenail (defined as one of the infected great toenails).
Exclusion criteria
* Females who are pregnant, lactating or likely to become pregnant during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients in Each Treatment Group With a Complete Therapeutic Cure | Day 365 | Complete therapeutic cure is defined as both complete clinical and mycological cure of the target toenail |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure | Day 365 | Almost complete therapeutic cure is defined as both mycological and satisfactory clinical cure of the target toenail |
| Number of Patients in Each Treatment Group With a Mycological Cure | day 365 | Mycological cure is defined as a negative KOH test and a negative fungal culture. |
| Number of Patients in Each Treatment Group With a Complete Clinical Cure | day 365 | Complete clinical cure is defined as 0% nail involvement. |
| Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure | day 365 | Satisfactory clinical cure is defined as \<5% of the target toenail involvement. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NVXT Topical Treatment Group A daily dosing for one 8-week treatment period
NVXT topical: topical treatment | 64 |
| NVXT Topical Treatment Group B daily dosing for two 8-week treatment periods separated by a 32-week rest period
NVXT topical: topical treatment | 62 |
| Placebo (Vehicle) Topical Treatment Group C two 8-week treatment periods separated by a 32-week rest period
Placebo (Vehicle) Topical: Placebo (Vehicle) Topical | 58 |
| Total | 184 |
Baseline characteristics
| Characteristic | Total | NVXT Topical Treatment Group A | NVXT Topical Treatment Group B | Placebo (Vehicle) Topical Treatment Group C |
|---|---|---|---|---|
| Age, Continuous | 51.8 years STANDARD_DEVIATION 14.2 | 51.6 years STANDARD_DEVIATION 15 | 53.1 years STANDARD_DEVIATION 14.7 | 50.8 years STANDARD_DEVIATION 12.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 118 Participants | 41 Participants | 38 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 66 Participants | 23 Participants | 24 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 27 Participants | 12 Participants | 7 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 157 Participants | 52 Participants | 55 Participants | 50 Participants |
| Sex: Female, Male Female | 59 Participants | 21 Participants | 17 Participants | 21 Participants |
| Sex: Female, Male Male | 125 Participants | 43 Participants | 45 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 64 | 0 / 62 | 0 / 58 |
| other Total, other adverse events | 19 / 64 | 14 / 62 | 13 / 58 |
| serious Total, serious adverse events | 0 / 64 | 0 / 62 | 1 / 58 |
Outcome results
Primary
Number of Patients in Each Treatment Group With a Complete Therapeutic Cure
Complete therapeutic cure is defined as both complete clinical and mycological cure of the target toenail
Time frame: Day 365
Population: 1 Subject from Group B and 1 Subject from Group C were excluded from Efficacy Analysis because they did not have positive mycological culture screenings. Also, 12 subjects from Group A, 13 from Group B, and 14 from Group C were excluded because they had no efficacy data for the relevant analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NVXT Topical Treatment Group A | Number of Patients in Each Treatment Group With a Complete Therapeutic Cure | 1 Participants |
| NVXT Topical Treatment Group B | Number of Patients in Each Treatment Group With a Complete Therapeutic Cure | 0 Participants |
| Placebo (Vehicle) Topical Treatment Group C | Number of Patients in Each Treatment Group With a Complete Therapeutic Cure | 1 Participants |
p-value: 0.4615Z-test, 2 sided
Primary
Number of Patients in Each Treatment Group With a Complete Therapeutic Cure
Complete therapeutic cure is defined as both complete clinical and mycological cure of the target toenail
Time frame: Day 141
Population: Groups A and B were combined to compare against Group C to determine statistically significant difference when combining both groups that received test treatment in the first 56 Days vs only placebo. 19 subjects from Group A+B and 9 from Group C were excluded because they had no efficacy data or they lacked positive mycological cultures.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NVXT Topical Treatment Group A | Number of Patients in Each Treatment Group With a Complete Therapeutic Cure | 0 Participants |
| NVXT Topical Treatment Group B | Number of Patients in Each Treatment Group With a Complete Therapeutic Cure | 1 Participants |
Secondary
Number of Patients in Each Treatment Group With a Complete Clinical Cure
Complete clinical cure is defined as 0% nail involvement.
Time frame: day 365
Population: 1 Subject from Group B and 1 Subject from Group C were excluded from Efficacy Analysis because they did not have positive mycological culture screenings. Also, 12 subjects from Group A, 13 from Group B, and 14 from Group C were excluded because they had no efficacy data for the relevant analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NVXT Topical Treatment Group A | Number of Patients in Each Treatment Group With a Complete Clinical Cure | 1 Participants |
| NVXT Topical Treatment Group B | Number of Patients in Each Treatment Group With a Complete Clinical Cure | 1 Participants |
| Placebo (Vehicle) Topical Treatment Group C | Number of Patients in Each Treatment Group With a Complete Clinical Cure | 1 Participants |
p-value: 1Z-test, 2 sided
Secondary
Number of Patients in Each Treatment Group With a Complete Clinical Cure
Complete clinical cure is defined as 0% nail involvement.
Time frame: Day 281
Population: Groups A and B were combined to compare against Group C to determine statistically significant difference when combining both groups that received test treatment in the first 56 Days vs only placebo. 24 subjects from Group A+B and 15 from Group C were excluded because they had no efficacy data or they lacked positive mycological cultures.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NVXT Topical Treatment Group A | Number of Patients in Each Treatment Group With a Complete Clinical Cure | 0 Participants |
| NVXT Topical Treatment Group B | Number of Patients in Each Treatment Group With a Complete Clinical Cure | 0 Participants |
Secondary
Number of Patients in Each Treatment Group With a Complete Clinical Cure
Complete clinical cure is defined as 0% nail involvement.
Time frame: Day 141
Population: Groups A and B were combined to compare against Group C to determine statistically significant difference when combining both groups that received test treatment in the first 56 Days vs only placebo. 19 subjects from Group A+B and 9 from Group C were excluded because they had no efficacy data or they lacked positive mycological cultures.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NVXT Topical Treatment Group A | Number of Patients in Each Treatment Group With a Complete Clinical Cure | 0 Participants |
| NVXT Topical Treatment Group B | Number of Patients in Each Treatment Group With a Complete Clinical Cure | 1 Participants |
Secondary
Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure
Almost complete therapeutic cure is defined as both mycological and satisfactory clinical cure of the target toenail
Time frame: Day 365
Population: 1 Subject from Group B and 1 Subject from Group C were excluded from Efficacy Analysis because they did not have positive mycological culture screenings. Also, 12 subjects from Group A, 13 from Group B, and 14 from Group C were excluded because they had no efficacy data for the relevant analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NVXT Topical Treatment Group A | Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure | 2 Participants |
| NVXT Topical Treatment Group B | Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure | 2 Participants |
| Placebo (Vehicle) Topical Treatment Group C | Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure | 4 Participants |
p-value: 0.0404Z-test, 2 sided
p-value: 0.2106Z-test, 2 sided
Secondary
Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure
Almost complete therapeutic cure is defined as both mycological and satisfactory clinical cure of the target toenail
Time frame: Day 141
Population: Groups A and B were combined to compare against Group C to determine statistically significant difference when combining both groups that received test treatment in the first 56 Days vs only placebo. 19 subjects from Group A+B and 9 from Group C were excluded because they had no efficacy data or they lacked positive mycological cultures.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NVXT Topical Treatment Group A | Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure | 1 Participants |
| NVXT Topical Treatment Group B | Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure | 1 Participants |
Secondary
Number of Patients in Each Treatment Group With a Mycological Cure
Mycological cure is defined as a negative KOH test and a negative fungal culture.
Time frame: day 365
Population: 1 Subject from Group B and 1 Subject from Group C were excluded from Efficacy Analysis because they did not have positive mycological culture screenings. Also, 12 subjects from Group A, 13 from Group B, and 14 from Group C were excluded because they had no efficacy data for the relevant analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NVXT Topical Treatment Group A | Number of Patients in Each Treatment Group With a Mycological Cure | 7 Participants |
| NVXT Topical Treatment Group B | Number of Patients in Each Treatment Group With a Mycological Cure | 13 Participants |
| Placebo (Vehicle) Topical Treatment Group C | Number of Patients in Each Treatment Group With a Mycological Cure | 12 Participants |
p-value: 1Z-test, 2 sided
Secondary
Number of Patients in Each Treatment Group With a Mycological Cure
Mycological cure is defined as a negative KOH test and a negative fungal culture.
Time frame: Day 141
Population: Groups A and B were combined to compare against Group C to determine statistically significant difference when combining both groups that received test treatment in the first 56 Days vs only placebo. 20 subjects from Group A+B and 10 from Group C were excluded because they had no efficacy data or they lacked positive mycological cultures.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NVXT Topical Treatment Group A | Number of Patients in Each Treatment Group With a Mycological Cure | 30 Participants |
| NVXT Topical Treatment Group B | Number of Patients in Each Treatment Group With a Mycological Cure | 10 Participants |
Secondary
Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure
Satisfactory clinical cure is defined as \<5% of the target toenail involvement.
Time frame: Day 141
Population: Groups A and B were combined to compare against Group C to determine statistically significant difference when combining both groups that received test treatment in the first 56 Days vs only placebo. 19 subjects from Group A+B and 9 from Group C were excluded because they had no efficacy data or they lacked positive mycological cultures.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NVXT Topical Treatment Group A | Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure | 2 Participants |
| NVXT Topical Treatment Group B | Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure | 2 Participants |
Secondary
Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure
Satisfactory clinical cure is defined as \<5% of the target toenail involvement.
Time frame: Day 281
Population: Groups A and B were combined to compare against Group C to determine statistically significant difference when combining both groups that received test treatment in the first 56 Days vs only placebo. 24 subjects from Group A+B and 15 from Group C were excluded because they had no efficacy data or they lacked positive mycological cultures.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NVXT Topical Treatment Group A | Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure | 2 Participants |
| NVXT Topical Treatment Group B | Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure | 1 Participants |
Secondary
Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure
Satisfactory clinical cure is defined as \<5% of the target toenail involvement.
Time frame: day 365
Population: 1 Subject from Group B and 1 Subject from Group C were excluded from Efficacy Analysis because they did not have positive mycological culture screenings. Also, 12 subjects from Group A, 13 from Group B, and 14 from Group C were excluded because they had no efficacy data for the relevant analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NVXT Topical Treatment Group A | Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure | 7 Participants |
| NVXT Topical Treatment Group B | Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure | 2 Participants |
| Placebo (Vehicle) Topical Treatment Group C | Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure | 5 Participants |
p-value: 0.2467Z-test, 2 sided