Safety and Efficacy of Econazole Nitrate Foam 1% and Foam Vehicle in Subjects With Tinea Pedis
Safety and Efficacy of Econazole Nitrate Foam 1% and Foam Vehicle in Subjects With Tinea Pedis
This is a study of the safety and efficacy of Econazole Nitrate Foam 1% and the Foam Vehicle
 in subjects with interdigital tinea pedis (athlete's foot between the toes). This is a 6 week
 study which has a 4 week treatment period and a 2 week follow-up evaluation. The study will
 also utilize Econazole Nitrate Cream 1% (for safety comparison) and a Placebo cream for
 blinding purposes only.
Inclusion Criteria:

 -  Be at least 12 years of age and of either sex.

 -  Have a clinical diagnosis of interdigital tinea pedis involving at least 2 web spaces
 in total which extends no more than approximately 1 inch proximal to the web spaces or
 metatarsophalangeal joints with at least i) moderate scaling and ii) mild erythema
 defined as a Grade 2 and Grade 1, respectively on the Grading of Signs and Symptoms
 (Section 10.1) at baseline.

 -  Be willing and able to give informed consent/assent or have their parent/guardian do
 so, if applicable.

 -  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. Evaluable subjects
 must have a positive KOH and a fungal culture positive for a dermatophyte in the skin
 scrapings taken at the Baseline Visit. Subjects with a positive KOH may be entered
 into the study pending the results of the 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 (confirmed by a negative urine pregnancy test (UPT) at
 baseline), 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 30 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 30 days prior to
 the start of the study. Systemic corticosteroids do not include intranasal, inhaled,
 and ophthalmic corticosteroids used for the management of allergies, pulmonary
 disorders or other conditions.

 -  Has a history of uncontrolled diabetes mellitus or is immunocompromised (due to
 disease, e.g., HIV, or medications).

 -  Has concurrent tinea infection e.g. tinea versicolor, tinea cruris, moccasin-type
 tinea pedis, etc. (in the opinion of the Investigator).

 -  Onychomycosis, involving ≥ 20% of the area of either great toenail or involvement of
 more than five toenails in total.

 -  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.