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

Recruitment & Eligibility

Inclusion Criteria

Be between 12 years and less than 18 years of age and of either sex.
Have a clinical diagnosis of interdigital tinea pedis
Parent/guardian has provided written informed consent and the subject has provided written assent.
Be willing and able to use the assigned study medication as directed and to commit to all follow-up visits for the duration of the study.
Have microscopic evidence (positive KOH) of the presence of fungi and a positive fungal culture.
Be in good health and free of any disease or physical condition which might, in the Investigator's opinion, expose the subject to an unacceptable risk by study participation.
Females must be non-pregnant, non-lactating and not intending to become pregnant during the course of the study.

Exclusion Criteria

Is pregnant, nursing or planning a pregnancy during the study
Has used topical antifungals or topical corticosteroids on the feet within 14 days prior to the start of the study.
Has received systemic antifungal therapy within 12 weeks prior to the start of the study medication.
Has used systemic antibacterials or systemic corticosteroids within 14 days prior to the start of the study.
Has a history of uncontrolled diabetes mellitus or is immunocompromised (due to disease, e.g., HIV, or medications).
Has concurrent moccasin-type tinea pedis (in the opinion of the Investigator).
Has any other skin disease which might interfere with the evaluation of tinea pedis.
Is currently enrolled in an investigational drug or device study.
Has received an investigational drug or treatment with an investigational device within 30 days prior to entering this study.
Is unreliable, including subjects with a history of drug or alcohol abuse.
Has known hypersensitivity to any of the components of the study medications.

Study & Design

Arm && Interventions

Group	Intervention	Description
Econazole Nitrate Foam	Econazole Nitrate	Investigational Drug Product
Vehicle Foam	placebo	Vehicle Foam Comparator
Econazole Nitrate Cream	Econazole Nitrate	Active comparator cream product

Primary Outcome Measures

Name	Time	Method
Plasma Levels of Econazole Nitrate	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	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).

Secondary Outcome Measures

Name	Time	Method
Dosing Compliance	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.

Recruitment & Eligibility