Trial Outcomes & Findings for Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis (NCT NCT01712360)
NCT ID: NCT01712360
Last Updated: 2016-07-14
Results Overview
Variables will be derived from naftifine plasma concentration at day 1. Variables to be analyzed: \- Partial area under the plasma concentration-time curve (0-24 hours postdose) (AUC), as calculated using the linear trapezoid rule. Variables will be derived from naftifine plasma concentration at day 14. Variables to be analyzed: \- Area under the plasma concentration-time curve (AUC) within one dosing interval at steady state (SS). AUCτ,ss= Area under the concentration curve within a dosing interval (τ = 24 hours) at steady state
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
56 participants
Primary outcome timeframe
Day 1 and Day 14
Results posted on
2016-07-14
Participant Flow
Participant milestones
| Measure |
NAFT500 (Pediatric)
Topical once a day for two weeks
NAFT500 (pediatric): Applied to both feet and groin area
|
NAFT600 (Pediatric)
Topical once a day for two weeks
NAFT600 (pediatric): Applied to both feet only
|
NAFT500 (Adult)
Topical once a day for two weeks
NAFT500 (adult): Applied to both feet and groin area
|
NAFT600 (Adult)
Topical once a day for two weeks
NAFT600 (adult): Applied to both feet
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
6
|
6
|
|
Overall Study
COMPLETED
|
22
|
21
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis
Baseline characteristics by cohort
| Measure |
NAFT500 (Pediatric)
n=22 Participants
Topical once a day for two weeks
NAFT500 (pediatric): Applied to both feet and groin area
|
NAFT600 (Pediatric)
n=22 Participants
Topical once a day for two weeks
NAFT600 (pediatric): Applied to both feet only
|
NAFT500 (Adult)
n=6 Participants
Topical once a day for two weeks
NAFT500 (adult): Applied to both feet and groin area
|
NAFT600 (Adult)
n=6 Participants
Topical once a day for two weeks
NAFT600 (adult): Applied to both feet
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
22 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
44 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
12 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Continuous
|
14.8 years
STANDARD_DEVIATION 1.5 • n=93 Participants
|
14.7 years
STANDARD_DEVIATION 1.7 • n=4 Participants
|
38.7 years
STANDARD_DEVIATION 6.5 • n=27 Participants
|
31.7 years
STANDARD_DEVIATION 11.2 • n=483 Participants
|
19.1 years
STANDARD_DEVIATION 9.6 • n=36 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
11 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
45 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
0 participants
n=93 Participants
|
7 participants
n=4 Participants
|
6 participants
n=27 Participants
|
6 participants
n=483 Participants
|
19 participants
n=36 Participants
|
|
Region of Enrollment
Honduras
|
20 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
20 participants
n=36 Participants
|
|
Region of Enrollment
Dominican Republic
|
2 participants
n=93 Participants
|
15 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
17 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Day 14Population: Pharmacokinetic analysis set (PKS), defined as the subset of subjects in the safety evaluation set (SES) with evaluable pharmacokinetic (PK) samples.
Variables will be derived from naftifine plasma concentration at day 1. Variables to be analyzed: \- Partial area under the plasma concentration-time curve (0-24 hours postdose) (AUC), as calculated using the linear trapezoid rule. Variables will be derived from naftifine plasma concentration at day 14. Variables to be analyzed: \- Area under the plasma concentration-time curve (AUC) within one dosing interval at steady state (SS). AUCτ,ss= Area under the concentration curve within a dosing interval (τ = 24 hours) at steady state
Outcome measures
| Measure |
NAFT500 (Pediatric)
n=20 Participants
Topical once a day for two weeks
NAFT500 (pediatric): Applied to both feet and groin area
|
NAFT600 (Pediatric)
n=22 Participants
Topical once a day for two weeks
NAFT600 (pediatric): Applied to both feet only
|
NAFT500 (Adult)
n=6 Participants
Topical once a day for two weeks
NAFT500 (adult): Applied to both feet and groin area
|
NAFT600 (Adult)
n=5 Participants
Topical once a day for two weeks
NAFT600 (adult): Applied to both feet
|
NAFT600 (Pediatric)
Topical once a day for two weeks
NAFT600 (pediatric): Applied to both feet only
|
NAFT600 (Adult)
Topical once a day for two weeks
NAFT600 (adult): Applied to both feet
|
|---|---|---|---|---|---|---|
|
Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose
AUC0-24 Day 1, Single Dose
|
138262.2 h*pg/mL
Geometric Coefficient of Variation 50.2
|
15890.1 h*pg/mL
Geometric Coefficient of Variation 211.6
|
68634.2 h*pg/mL
Geometric Coefficient of Variation 95.4
|
17213.9 h*pg/mL
Geometric Coefficient of Variation 88.1
|
—
|
—
|
|
Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose
AUCτ,ss Day 14 Multiple Dose
|
192485.4 h*pg/mL
Geometric Coefficient of Variation 74.9
|
60038.5 h*pg/mL
Geometric Coefficient of Variation 131.1
|
124596.0 h*pg/mL
Geometric Coefficient of Variation 49.9
|
72849.8 h*pg/mL
Geometric Coefficient of Variation 71.1
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 and Day 14Population: Pharmacokinetic analysis set (PKS), defined as the subset of subjects in safety evaluation set (SES) with evaluable pharmacokinetic (PK) samples.
Variables will be derived from naftifine plasma concentration at day 1. Variables to be analyzed: \- Maximum observed plasma concentration (Cmax): the highest plasma concentration in each subject after single dose. Variables will be derived from naftifine plasma concentration at day 14. Variables to be analyzed: \- Maximum observed plasma concentration (Cmax): the highest plasma concentration in each subject at steady state (SS).
Outcome measures
| Measure |
NAFT500 (Pediatric)
n=20 Participants
Topical once a day for two weeks
NAFT500 (pediatric): Applied to both feet and groin area
|
NAFT600 (Pediatric)
n=22 Participants
Topical once a day for two weeks
NAFT600 (pediatric): Applied to both feet only
|
NAFT500 (Adult)
n=6 Participants
Topical once a day for two weeks
NAFT500 (adult): Applied to both feet and groin area
|
NAFT600 (Adult)
n=5 Participants
Topical once a day for two weeks
NAFT600 (adult): Applied to both feet
|
NAFT600 (Pediatric)
Topical once a day for two weeks
NAFT600 (pediatric): Applied to both feet only
|
NAFT600 (Adult)
Topical once a day for two weeks
NAFT600 (adult): Applied to both feet
|
|---|---|---|---|---|---|---|
|
Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose
Cmax Day 1, Single Dose
|
9213.35 pg/mL
Geometric Coefficient of Variation 48.4
|
1397.77 pg/mL
Geometric Coefficient of Variation 153.8
|
3983.34 pg/mL
Geometric Coefficient of Variation 83.0
|
1741.02 pg/mL
Geometric Coefficient of Variation 69.2
|
—
|
—
|
|
Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose
Cmax, SS Day 14 Multiple Dose
|
12727.36 pg/mL
Geometric Coefficient of Variation 67.2
|
3813.38 pg/mL
Geometric Coefficient of Variation 153.9
|
6826.70 pg/mL
Geometric Coefficient of Variation 51.3
|
3538.84 pg/mL
Geometric Coefficient of Variation 73.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 28Population: Full analysis set, defined as subset of subjects in the safety evaluation set (SES) for whom any efficacy variable is available.
Efficacy variables to be analyzed after 2 weeks of once daily application of both products (NAFT-500 or NAFT-600). Efficacy variables to be analyzed: * Complete cure * Treatment effectiveness * Mycological cure * Clinical success * Clinical cure
Outcome measures
| Measure |
NAFT500 (Pediatric)
n=22 Participants
Topical once a day for two weeks
NAFT500 (pediatric): Applied to both feet and groin area
|
NAFT600 (Pediatric)
n=6 Participants
Topical once a day for two weeks
NAFT600 (pediatric): Applied to both feet only
|
NAFT500 (Adult)
n=22 Participants
Topical once a day for two weeks
NAFT500 (adult): Applied to both feet and groin area
|
NAFT600 (Adult)
n=6 Participants
Topical once a day for two weeks
NAFT600 (adult): Applied to both feet
|
NAFT600 (Pediatric)
n=22 Participants
Topical once a day for two weeks
NAFT600 (pediatric): Applied to both feet only
|
NAFT600 (Adult)
n=5 Participants
Topical once a day for two weeks
NAFT600 (adult): Applied to both feet
|
|---|---|---|---|---|---|---|
|
Efficacy Variables
Complete Cure
|
59.1 Percentage (%) of subjects (90% CI)
Interval 39.5 to 76.7
|
0 Percentage (%) of subjects (90% CI)
Interval 0.0 to 0.0
|
63.6 Percentage (%) of subjects (90% CI)
Interval 43.9 to 80.4
|
16.7 Percentage (%) of subjects (90% CI)
Interval 0.9 to 58.2
|
27.3 Percentage (%) of subjects (90% CI)
Interval 12.6 to 46.8
|
0 Percentage (%) of subjects (90% CI)
Interval 0.0 to 0.0
|
|
Efficacy Variables
Treatment Effectiveness
|
63.6 Percentage (%) of subjects (90% CI)
Interval 43.9 to 80.4
|
0 Percentage (%) of subjects (90% CI)
Interval 0.0 to 0.0
|
63.6 Percentage (%) of subjects (90% CI)
Interval 43.9 to 80.4
|
50.0 Percentage (%) of subjects (90% CI)
Interval 15.3 to 84.7
|
54.5 Percentage (%) of subjects (90% CI)
Interval 35.3 to 72.9
|
20.0 Percentage (%) of subjects (90% CI)
Interval 1.0 to 65.7
|
|
Efficacy Variables
Mycological Cure
|
68.2 Percentage (%) of subjects (90% CI)
Interval 48.5 to 84.0
|
16.7 Percentage (%) of subjects (90% CI)
Interval 0.9 to 58.2
|
72.7 Percentage (%) of subjects (90% CI)
Interval 53.2 to 87.4
|
66.7 Percentage (%) of subjects (90% CI)
Interval 27.1 to 93.7
|
63.6 Percentage (%) of subjects (90% CI)
Interval 43.9 to 80.4
|
20.0 Percentage (%) of subjects (90% CI)
Interval 1.0 to 65.7
|
|
Efficacy Variables
Clinical Success
|
90.9 Percentage (%) of subjects (90% CI)
Interval 74.1 to 98.4
|
66.7 Percentage (%) of subjects (90% CI)
Interval 27.1 to 93.7
|
90.9 Percentage (%) of subjects (90% CI)
Interval 74.1 to 98.4
|
66.7 Percentage (%) of subjects (90% CI)
Interval 27.1 to 93.7
|
81.8 Percentage (%) of subjects (90% CI)
Interval 63.1 to 93.5
|
80 Percentage (%) of subjects (90% CI)
Interval 34.3 to 99.0
|
|
Efficacy Variables
Clinical Cure
|
81.8 Percentage (%) of subjects (90% CI)
Interval 63.1 to 93.5
|
16.7 Percentage (%) of subjects (90% CI)
Interval 0.9 to 58.2
|
81.8 Percentage (%) of subjects (90% CI)
Interval 63.1 to 93.5
|
33.3 Percentage (%) of subjects (90% CI)
Interval 6.3 to 72.9
|
40.9 Percentage (%) of subjects (90% CI)
Interval 23.3 to 60.5
|
20.0 Percentage (%) of subjects (90% CI)
Interval 1.0 to 65.7
|
SECONDARY outcome
Timeframe: Day 28Population: Full analysis set, defined as subset of subjects in the safety evaluation set (SES) for whom any efficacy variable is available.
Efficacy variables to be analyzed after 2 weeks of once daily application of both products (NAFT-500 or NAFT-600). Efficacy variables to be analyzed: \- Subject satisfaction
Outcome measures
| Measure |
NAFT500 (Pediatric)
n=22 Participants
Topical once a day for two weeks
NAFT500 (pediatric): Applied to both feet and groin area
|
NAFT600 (Pediatric)
n=6 Participants
Topical once a day for two weeks
NAFT600 (pediatric): Applied to both feet only
|
NAFT500 (Adult)
n=22 Participants
Topical once a day for two weeks
NAFT500 (adult): Applied to both feet and groin area
|
NAFT600 (Adult)
n=6 Participants
Topical once a day for two weeks
NAFT600 (adult): Applied to both feet
|
NAFT600 (Pediatric)
n=22 Participants
Topical once a day for two weeks
NAFT600 (pediatric): Applied to both feet only
|
NAFT600 (Adult)
n=5 Participants
Topical once a day for two weeks
NAFT600 (adult): Applied to both feet
|
|---|---|---|---|---|---|---|
|
Efficacy Variables
Excellent Improvement
|
81.8 Percentage (%) of subjects
|
0 Percentage (%) of subjects
|
86.4 Percentage (%) of subjects
|
16.7 Percentage (%) of subjects
|
54.5 Percentage (%) of subjects
|
20.0 Percentage (%) of subjects
|
|
Efficacy Variables
Much Improved
|
13.6 Percentage (%) of subjects
|
83.3 Percentage (%) of subjects
|
13.6 Percentage (%) of subjects
|
50.0 Percentage (%) of subjects
|
36.4 Percentage (%) of subjects
|
60.0 Percentage (%) of subjects
|
|
Efficacy Variables
Improved
|
4.5 Percentage (%) of subjects
|
16.7 Percentage (%) of subjects
|
0 Percentage (%) of subjects
|
33.3 Percentage (%) of subjects
|
4.5 Percentage (%) of subjects
|
20.0 Percentage (%) of subjects
|
|
Efficacy Variables
No Change
|
0 Percentage (%) of subjects
|
0 Percentage (%) of subjects
|
0 Percentage (%) of subjects
|
0 Percentage (%) of subjects
|
0 Percentage (%) of subjects
|
0 Percentage (%) of subjects
|
|
Efficacy Variables
Worse
|
0 Percentage (%) of subjects
|
0 Percentage (%) of subjects
|
0 Percentage (%) of subjects
|
0 Percentage (%) of subjects
|
0 Percentage (%) of subjects
|
0 Percentage (%) of subjects
|
Adverse Events
NAFT500 (Pediatric)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
NAFT600 (Pediatric)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
NAFT500 (Adult)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NAFT600 (Adult)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NAFT500 (Pediatric)
n=22 participants at risk
Topical once a day for two weeks
NAFT500 (pediatric): Applied to both feet and groin area
|
NAFT600 (Pediatric)
n=22 participants at risk
Topical once a day for two weeks
NAFT600 (pediatric): Applied to both feet only
|
NAFT500 (Adult)
n=6 participants at risk
Topical once a day for two weeks
NAFT500 (adult): Applied to both feet and groin area
|
NAFT600 (Adult)
n=6 participants at risk
Topical once a day for two weeks
NAFT600 (adult): Applied to both feet
|
|---|---|---|---|---|
|
Infections and infestations
Pharyngitis
|
0.00%
0/22
|
4.5%
1/22 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Investigations
Blood creatinine increased
|
0.00%
0/22
|
4.5%
1/22 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
Headaches
|
0.00%
0/22
|
0.00%
0/22
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Influenza
|
9.1%
2/22 • Number of events 2
|
0.00%
0/22
|
0.00%
0/6
|
0.00%
0/6
|
|
Infections and infestations
Tonsillitis
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
0.00%
0/6
|
0.00%
0/6
|
|
Renal and urinary disorders
Urinary tract infection
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
0.00%
0/6
|
0.00%
0/6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place