Comparative PK Study of Econazole Nitrate Foam and Econazole Nitrate Cream in Subjects With Interdigital Tinea Pedis Aged 12 Years to Less Than 18 Years
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|ClinicalTrials.gov Identifier: NCT01696799|
Recruitment Status : Completed
First Posted : October 1, 2012
Last Update Posted : October 1, 2012
|Condition or disease||Intervention/treatment||Phase|
|Interdigital Tinea Pedis||Drug: Econazole Nitrate Drug: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Multi-Center, Randomized Comparative Study of the Pharmacokinetics of Econazole Nitrate 1% Foam and Econazole Nitrate 1% Cream in Subjects With Interdigital Tinea Pedis Aged 12 Years to Less Than 18 Years|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||August 2012|
Experimental: Econazole Nitrate Foam
Investigational Drug Product
|Drug: Econazole Nitrate|
Placebo Comparator: Vehicle Foam
Vehicle Foam Comparator
Active Comparator: Econazole Nitrate Cream
Active comparator cream product
|Drug: Econazole Nitrate|
- Plasma Levels of Econazole Nitrate [ Time Frame: 28 Days ]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.
- Investigator Assessment of Response to Treatment [ Time Frame: 28 Days ]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).
- Dosing Compliance [ Time Frame: 28 Days ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01696799
|United States, California|
|San Diego, California, United States, 92123|