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| Name | Class |
|---|---|
| AmDerma Pharmaceuticals, LLC | INDUSTRY |
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To compare the pharmacokinetics of Econazole Nitrate Foam with Econazole Nitrate Cream in subjects with interdigital tinea pedis aged 12 years to less than 18 years.
Based on the results of a previous clinical study evaluating the pharmacokinetics, safety and efficacy of EN Foam versus the reference listed econazole nitrate cream and the foam vehicle in adults, the current clinical study is being conducted to provide additional pharmacokinetic data for EN in the foam formulation in subjects ages 12 to less than 18 years with interdigital tinea pedis to support a clinical bridge for systemic safety to the RLD in this pediatric population. The study also includes clinical and safety endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Econazole Nitrate Foam | Experimental | Investigational Drug Product |
|
| Vehicle Foam | Placebo Comparator | Vehicle Foam Comparator |
|
| Econazole Nitrate Cream | Active Comparator | Active comparator cream product |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Econazole Nitrate | Drug |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Levels of Econazole Nitrate | Blood will be taken at Baseline (Day 1) prior to the application of medication, and at the end of treatment (Day 28), just prior to the last dose of medication, and at 7 (±1 hr) hours post-drug application and a third blood draw 4 (±1 hr) hours after the second PK blood draw. | 28 Days |
| Investigator Assessment of Response to Treatment | At the end of treatment (Day 28), the Investigator will assess the subject's response to treatment using a 5-point scale (1 = excellent, 2 = very good, 3 = good, 4 = fair, and 5 = poor). | 28 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Dosing Compliance | Measures of study medication compliance will include the total number of applications, duration of treatment, and the total amount of study medication used. The amount of study medication used will be determined post-study following thereturn of all clinical supplies. | 28 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Therapeutics Inc. | San Diego | California | 92123 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 5, 2012 | |
| Reset | Jan 9, 2013 | |
| Release | Jan 9, 2013 |
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| Drug |
|
| Reset | Feb 11, 2013 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 5, 2012 | Jan 9, 2013 | |||
| Jan 9, 2013 | Feb 11, 2013 |
| ID | Term |
|---|---|
| D004464 | Econazole |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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