Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Tinea Pedis and Cruris |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NAFT500 (pediatric) | Experimental | Topical once a day for two weeks |
|
| NAFT600 (pediatric) | Experimental | Topical once a day for two weeks |
|
| NAFT500 (adult) | Experimental | Topical once a day for two weeks |
|
| NAFT600 (adult) | Experimental | Topical once a day for two weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NAFT500 (pediatric) | Drug | Applied to both feet and groin area |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 1 and Day 14 |
| 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). | Day 1 and Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Day 28 |
| Efficacy Variables |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alan Fleischer, MD | Merz Pharmaceutical, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merz Investigative Site #001272 | Austin | Texas | 78759 | United States | ||
| Merz Investigative Site #001261 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | NAFT500 (Pediatric) | Topical once a day for two weeks NAFT500 (pediatric): Applied to both feet and groin area |
| FG001 | NAFT600 (Pediatric) | Topical once a day for two weeks NAFT600 (pediatric): Applied to both feet only |
| FG002 | NAFT500 (Adult) | Topical once a day for two weeks NAFT500 (adult): Applied to both feet and groin area |
| FG003 | NAFT600 (Adult) | Topical once a day for two weeks NAFT600 (adult): Applied to both feet |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety Analysis Set which is the subset of subjects who have been exposed to the study medication at least once
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | NAFT500 (Pediatric) | Topical once a day for two weeks NAFT500 (pediatric): Applied to both feet and groin area |
| BG001 | NAFT600 (Pediatric) | Topical once a day for two weeks NAFT600 (pediatric): Applied to both feet only |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Pharmacokinetic analysis set (PKS), defined as the subset of subjects in the safety evaluation set (SES) with evaluable pharmacokinetic (PK) samples. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | Day 1 and Day 14 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NAFT500 (Pediatric) | Topical once a day for two weeks NAFT500 (pediatric): Applied to both feet and groin area |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pharyngitis | Infections and infestations |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ashlee Duncan | Merz North America, Inc. | 984-222-6040 | Ashlee.Duncan@merz.com |
Not provided
| ID | Term |
|---|---|
| D014008 | Tinea Pedis |
| D000084002 | Tinea Cruris |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
Not provided
Not provided
| ID | Term |
|---|---|
| C029178 | naftifine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| NAFT600 (pediatric) | Drug | Applied to both feet only |
|
|
| NAFT500 (adult) | Drug | Applied to both feet and groin area |
|
|
| NAFT600 (adult) | Drug | Applied to both feet |
|
|
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 |
| Day 28 |
| College Station |
| Texas |
| 77802 |
| United States |
| Merz Investigative Site #180001 | Santo Domingo | Santo Domingo Province | Dominican Republic |
| Merz Investigative Site #504001 | San Pedro Sula | San Pedro Sula | Honduras |
| BG002 | NAFT500 (Adult) | Topical once a day for two weeks NAFT500 (adult): Applied to both feet and groin area |
| BG003 | NAFT600 (Adult) | Topical once a day for two weeks NAFT600 (adult): Applied to both feet |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Topical once a day for two weeks
NAFT500 (pediatric): Applied to both feet and groin area
| OG001 | NAFT600 (Pediatric) | Topical once a day for two weeks NAFT600 (pediatric): Applied to both feet only |
| OG002 | NAFT500 (Adult) | Topical once a day for two weeks NAFT500 (adult): Applied to both feet and groin area |
| OG003 | NAFT600 (Adult) | Topical once a day for two weeks NAFT600 (adult): Applied to both feet |
|
|
| 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:
| Full analysis set, defined as subset of subjects in the safety evaluation set (SES) for whom any efficacy variable is available. | Posted | Number | 90% Confidence Interval | Percentage (%) of subjects (90% CI) | Day 28 |
|
|
|
| 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). | Pharmacokinetic analysis set (PKS), defined as the subset of subjects in safety evaluation set (SES) with evaluable pharmacokinetic (PK) samples. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | Day 1 and Day 14 |
|
|
|
| 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 | Full analysis set, defined as subset of subjects in the safety evaluation set (SES) for whom any efficacy variable is available. | Posted | Number | Percentage (%) of subjects | Day 28 |
|
|
|
| 0 |
| 22 |
| 4 |
| 22 |
| EG001 | NAFT600 (Pediatric) | Topical once a day for two weeks NAFT600 (pediatric): Applied to both feet only | 0 | 22 | 2 | 22 |
| EG002 | NAFT500 (Adult) | Topical once a day for two weeks NAFT500 (adult): Applied to both feet and groin area | 0 | 6 | 0 | 6 |
| EG003 | NAFT600 (Adult) | Topical once a day for two weeks NAFT600 (adult): Applied to both feet | 0 | 6 | 1 | 6 |
| Blood creatinine increased | Investigations |
|
| Headaches | Nervous system disorders |
|
| Influenza | Infections and infestations |
|
| Tonsillitis | Infections and infestations |
|
| Urinary tract infection | Renal and urinary disorders |
|
Not provided
Not provided
| D007239 |
| Infections |
| D012874 | Skin Diseases, Infectious |
| D005533 | Foot Dermatoses |
| D005534 | Foot Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011537 | Pruritus |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007402 | Intertrigo |
| D003872 | Dermatitis |
| D017443 | Skin Diseases, Eczematous |
| Treatment Effectiveness |
|
| Mycological Cure |
|
| Clinical Success |
|
| Clinical Cure |
|
| Cmax, SS Day 14 Multiple Dose |
|
| Much Improved |
|
| Improved |
|
| No Change |
|
| Worse |
|