Tinea Cruris, Tinea Pedis
Conditions
Keywords
Tinea Pedis, Tinea Cruris, Athlete foot, Jock itch
Brief summary
This study is being done to see how the body is affected when a study drug is applied to both feet if the subject has athlete's foot or to both feet and the groin area if the subject has both athlete's foot and jock itch. Safety of the drug and how well the drug works will also be measured.
Detailed description
Study population, diagnosis, and main criteria for inclusion: Tinea pedis and Tinea cruris (NAFT-500): Male or non-pregnant female subjects aged 12 to 17 years, 11 months old of any race with Tinea pedis and Tinea cruris infections confirmed by a positive potassium hydroxide (KOH) analysis from both the feet and bikini area. Both cases (feet and bikini area) must be characterized by clinical evidence of a Tinea pedis and Tinea cruris infection. Additional, approximately 4 pharmacokinetic (PK) evaluable adult subjects with the same condition will serve as a control. Tinea pedis (NAFT-600): Male or non-pregnant female subjects aged 12 to 17 years, 11 months old of any race with Tinea pedis infection confirmed by a positive potassium hydroxide (KOH) analysis from both feet. Both feet must be characterized by clinical evidence of a Tinea pedis infection. Additional, approximately 4 pharmacokinetic (PK) evaluable adult subjects with the same condition will serve as a control.
Interventions
DRUGNAFT500 (pediatric)
Applied to both feet and groin area
DRUGNAFT600 (pediatric)
Applied to both feet only
DRUGNAFT500 (adult)
Applied to both feet and groin area
DRUGNAFT600 (adult)
Applied to both feet
Sponsors
Merz North America, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects must have Tinea pedis on both feet and Tinea cruris infections for NAFT-500; both conditions must be characterized by clinical evidence of a Tinea infection. * Subjects must have Tinea pedis on both feet for NAFT-600; the condition must be characterized by clinical evidence of a Tinea infection.
Exclusion criteria
* A known hypersensitivity to study medications or their components * Any severe condition of Tinea pedis (incapacitating) * Any dermatological disease and or condition in the treatment or surrounding area that may prevent application of the study product such as foot psoriasis, corns and /or callus involving any web spaces, or atopic or contact dermatitis * Positive pregnancy test * Any history or current evidence (physical or laboratory) of anemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose | Day 1 and Day 14 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Variables | Day 28 | 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 |
Countries
Dominican Republic, Honduras, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NAFT500 (Pediatric) Topical once a day for two weeks
NAFT500 (pediatric): Applied to both feet and groin area | 22 |
| NAFT600 (Pediatric) Topical once a day for two weeks
NAFT600 (pediatric): Applied to both feet only | 22 |
| NAFT500 (Adult) Topical once a day for two weeks
NAFT500 (adult): Applied to both feet and groin area | 6 |
| NAFT600 (Adult) Topical once a day for two weeks
NAFT600 (adult): Applied to both feet | 6 |
| Total | 56 |
Baseline characteristics
| Characteristic | NAFT500 (Pediatric) | NAFT600 (Pediatric) | NAFT500 (Adult) | NAFT600 (Adult) | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 22 Participants | 22 Participants | 0 Participants | 0 Participants | 44 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 6 Participants | 6 Participants | 12 Participants |
| Age, Continuous | 14.8 years STANDARD_DEVIATION 1.5 | 14.7 years STANDARD_DEVIATION 1.7 | 38.7 years STANDARD_DEVIATION 6.5 | 31.7 years STANDARD_DEVIATION 11.2 | 19.1 years STANDARD_DEVIATION 9.6 |
| Region of Enrollment Dominican Republic | 2 participants | 15 participants | 0 participants | 0 participants | 17 participants |
| Region of Enrollment Honduras | 20 participants | 0 participants | 0 participants | 0 participants | 20 participants |
| Region of Enrollment United States | 0 participants | 7 participants | 6 participants | 6 participants | 19 participants |
| Sex: Female, Male Female | 5 Participants | 4 Participants | 0 Participants | 2 Participants | 11 Participants |
| Sex: Female, Male Male | 17 Participants | 18 Participants | 6 Participants | 4 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 22 | 2 / 22 | 0 / 6 | 1 / 6 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 | 0 / 6 | 0 / 6 |
Outcome results
Primary
Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose
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
Time frame: Day 1 and Day 14
Population: Pharmacokinetic analysis set (PKS), defined as the subset of subjects in the safety evaluation set (SES) with evaluable pharmacokinetic (PK) samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NAFT500 (Pediatric) | 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 |
| NAFT500 (Pediatric) | 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 |
| NAFT600 (Pediatric) | Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose | AUCτ,ss Day 14 Multiple Dose | 60038.5 h*pg/mL | Geometric Coefficient of Variation 131.1 |
| NAFT600 (Pediatric) | Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose | AUC0-24 Day 1, Single Dose | 15890.1 h*pg/mL | Geometric Coefficient of Variation 211.6 |
| NAFT500 (Adult) | Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose | AUC0-24 Day 1, Single Dose | 68634.2 h*pg/mL | Geometric Coefficient of Variation 95.4 |
| NAFT500 (Adult) | Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose | AUCτ,ss Day 14 Multiple Dose | 124596.0 h*pg/mL | Geometric Coefficient of Variation 49.9 |
| NAFT600 (Adult) | Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose | AUC0-24 Day 1, Single Dose | 17213.9 h*pg/mL | Geometric Coefficient of Variation 88.1 |
| NAFT600 (Adult) | Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose | AUCτ,ss Day 14 Multiple Dose | 72849.8 h*pg/mL | Geometric Coefficient of Variation 71.1 |
Primary
Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose
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).
Time frame: Day 1 and Day 14
Population: Pharmacokinetic analysis set (PKS), defined as the subset of subjects in safety evaluation set (SES) with evaluable pharmacokinetic (PK) samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| NAFT500 (Pediatric) | Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose | Cmax Day 1, Single Dose | 9213.35 pg/mL | Geometric Coefficient of Variation 48.4 |
| NAFT500 (Pediatric) | Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose | Cmax, SS Day 14 Multiple Dose | 12727.36 pg/mL | Geometric Coefficient of Variation 67.2 |
| NAFT600 (Pediatric) | Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose | Cmax, SS Day 14 Multiple Dose | 3813.38 pg/mL | Geometric Coefficient of Variation 153.9 |
| NAFT600 (Pediatric) | Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose | Cmax Day 1, Single Dose | 1397.77 pg/mL | Geometric Coefficient of Variation 153.8 |
| NAFT500 (Adult) | Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose | Cmax Day 1, Single Dose | 3983.34 pg/mL | Geometric Coefficient of Variation 83 |
| NAFT500 (Adult) | Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose | Cmax, SS Day 14 Multiple Dose | 6826.70 pg/mL | Geometric Coefficient of Variation 51.3 |
| NAFT600 (Adult) | Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose | Cmax Day 1, Single Dose | 1741.02 pg/mL | Geometric Coefficient of Variation 69.2 |
| NAFT600 (Adult) | Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose | Cmax, SS Day 14 Multiple Dose | 3538.84 pg/mL | Geometric Coefficient of Variation 73.3 |
Secondary
Efficacy Variables
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
Time frame: Day 28
Population: Full analysis set, defined as subset of subjects in the safety evaluation set (SES) for whom any efficacy variable is available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NAFT500 (Pediatric) | Efficacy Variables | Clinical Success | 90.9 Percentage (%) of subjects (90% CI) |
| NAFT500 (Pediatric) | Efficacy Variables | Treatment Effectiveness | 63.6 Percentage (%) of subjects (90% CI) |
| NAFT500 (Pediatric) | Efficacy Variables | Complete Cure | 59.1 Percentage (%) of subjects (90% CI) |
| NAFT500 (Pediatric) | Efficacy Variables | Clinical Cure | 81.8 Percentage (%) of subjects (90% CI) |
| NAFT500 (Pediatric) | Efficacy Variables | Mycological Cure | 68.2 Percentage (%) of subjects (90% CI) |
| NAFT600 (Pediatric) | Efficacy Variables | Treatment Effectiveness | 0 Percentage (%) of subjects (90% CI) |
| NAFT600 (Pediatric) | Efficacy Variables | Clinical Success | 66.7 Percentage (%) of subjects (90% CI) |
| NAFT600 (Pediatric) | Efficacy Variables | Complete Cure | 0 Percentage (%) of subjects (90% CI) |
| NAFT600 (Pediatric) | Efficacy Variables | Clinical Cure | 16.7 Percentage (%) of subjects (90% CI) |
| NAFT600 (Pediatric) | Efficacy Variables | Mycological Cure | 16.7 Percentage (%) of subjects (90% CI) |
| NAFT500 (Adult) | Efficacy Variables | Treatment Effectiveness | 63.6 Percentage (%) of subjects (90% CI) |
| NAFT500 (Adult) | Efficacy Variables | Clinical Success | 90.9 Percentage (%) of subjects (90% CI) |
| NAFT500 (Adult) | Efficacy Variables | Clinical Cure | 81.8 Percentage (%) of subjects (90% CI) |
| NAFT500 (Adult) | Efficacy Variables | Mycological Cure | 72.7 Percentage (%) of subjects (90% CI) |
| NAFT500 (Adult) | Efficacy Variables | Complete Cure | 63.6 Percentage (%) of subjects (90% CI) |
| NAFT600 (Adult) | Efficacy Variables | Mycological Cure | 66.7 Percentage (%) of subjects (90% CI) |
| NAFT600 (Adult) | Efficacy Variables | Complete Cure | 16.7 Percentage (%) of subjects (90% CI) |
| NAFT600 (Adult) | Efficacy Variables | Treatment Effectiveness | 50.0 Percentage (%) of subjects (90% CI) |
| NAFT600 (Adult) | Efficacy Variables | Clinical Success | 66.7 Percentage (%) of subjects (90% CI) |
| NAFT600 (Adult) | Efficacy Variables | Clinical Cure | 33.3 Percentage (%) of subjects (90% CI) |
| NAFT600 (Pediatric) | Efficacy Variables | Clinical Success | 81.8 Percentage (%) of subjects (90% CI) |
| NAFT600 (Pediatric) | Efficacy Variables | Complete Cure | 27.3 Percentage (%) of subjects (90% CI) |
| NAFT600 (Pediatric) | Efficacy Variables | Clinical Cure | 40.9 Percentage (%) of subjects (90% CI) |
| NAFT600 (Pediatric) | Efficacy Variables | Treatment Effectiveness | 54.5 Percentage (%) of subjects (90% CI) |
| NAFT600 (Pediatric) | Efficacy Variables | Mycological Cure | 63.6 Percentage (%) of subjects (90% CI) |
| NAFT600 (Adult) | Efficacy Variables | Complete Cure | 0 Percentage (%) of subjects (90% CI) |
| NAFT600 (Adult) | Efficacy Variables | Clinical Success | 80 Percentage (%) of subjects (90% CI) |
| NAFT600 (Adult) | Efficacy Variables | Treatment Effectiveness | 20.0 Percentage (%) of subjects (90% CI) |
| NAFT600 (Adult) | Efficacy Variables | Clinical Cure | 20.0 Percentage (%) of subjects (90% CI) |
| NAFT600 (Adult) | Efficacy Variables | Mycological Cure | 20.0 Percentage (%) of subjects (90% CI) |
Secondary
Efficacy Variables
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
Time frame: Day 28
Population: Full analysis set, defined as subset of subjects in the safety evaluation set (SES) for whom any efficacy variable is available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NAFT500 (Pediatric) | Efficacy Variables | Improved | 4.5 Percentage (%) of subjects |
| NAFT500 (Pediatric) | Efficacy Variables | No Change | 0 Percentage (%) of subjects |
| NAFT500 (Pediatric) | Efficacy Variables | Much Improved | 13.6 Percentage (%) of subjects |
| NAFT500 (Pediatric) | Efficacy Variables | Excellent Improvement | 81.8 Percentage (%) of subjects |
| NAFT500 (Pediatric) | Efficacy Variables | Worse | 0 Percentage (%) of subjects |
| NAFT600 (Pediatric) | Efficacy Variables | Excellent Improvement | 0 Percentage (%) of subjects |
| NAFT600 (Pediatric) | Efficacy Variables | Improved | 16.7 Percentage (%) of subjects |
| NAFT600 (Pediatric) | Efficacy Variables | No Change | 0 Percentage (%) of subjects |
| NAFT600 (Pediatric) | Efficacy Variables | Much Improved | 83.3 Percentage (%) of subjects |
| NAFT600 (Pediatric) | Efficacy Variables | Worse | 0 Percentage (%) of subjects |
| NAFT500 (Adult) | Efficacy Variables | Improved | 0 Percentage (%) of subjects |
| NAFT500 (Adult) | Efficacy Variables | Excellent Improvement | 86.4 Percentage (%) of subjects |
| NAFT500 (Adult) | Efficacy Variables | Much Improved | 13.6 Percentage (%) of subjects |
| NAFT500 (Adult) | Efficacy Variables | No Change | 0 Percentage (%) of subjects |
| NAFT500 (Adult) | Efficacy Variables | Worse | 0 Percentage (%) of subjects |
| NAFT600 (Adult) | Efficacy Variables | Much Improved | 50.0 Percentage (%) of subjects |
| NAFT600 (Adult) | Efficacy Variables | Improved | 33.3 Percentage (%) of subjects |
| NAFT600 (Adult) | Efficacy Variables | No Change | 0 Percentage (%) of subjects |
| NAFT600 (Adult) | Efficacy Variables | Excellent Improvement | 16.7 Percentage (%) of subjects |
| NAFT600 (Adult) | Efficacy Variables | Worse | 0 Percentage (%) of subjects |
| NAFT600 (Pediatric) | Efficacy Variables | Much Improved | 36.4 Percentage (%) of subjects |
| NAFT600 (Pediatric) | Efficacy Variables | No Change | 0 Percentage (%) of subjects |
| NAFT600 (Pediatric) | Efficacy Variables | Improved | 4.5 Percentage (%) of subjects |
| NAFT600 (Pediatric) | Efficacy Variables | Worse | 0 Percentage (%) of subjects |
| NAFT600 (Pediatric) | Efficacy Variables | Excellent Improvement | 54.5 Percentage (%) of subjects |
| NAFT600 (Adult) | Efficacy Variables | Excellent Improvement | 20.0 Percentage (%) of subjects |
| NAFT600 (Adult) | Efficacy Variables | No Change | 0 Percentage (%) of subjects |
| NAFT600 (Adult) | Efficacy Variables | Much Improved | 60.0 Percentage (%) of subjects |
| NAFT600 (Adult) | Efficacy Variables | Worse | 0 Percentage (%) of subjects |
| NAFT600 (Adult) | Efficacy Variables | Improved | 20.0 Percentage (%) of subjects |