Safety and Efficacy of Econazole Nitrate Foam 1% and Foam Vehicle in Subjects With Tinea Pedis

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 spacesin total which extends no more than approximately 1 inch proximal to the web spaces ormetatarsophalangeal joints with at least i) moderate scaling and ii) mild erythemadefined 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 doso, if applicable.

• Be willing and able to use the assigned study medication as directed and to commit toall follow-up visits for the duration of the study.

• Have microscopic evidence (positive KOH) of the presence of fungi. Evaluable subjectsmust have a positive KOH and a fungal culture positive for a dermatophyte in the skinscrapings taken at the Baseline Visit. Subjects with a positive KOH may be enteredinto the study pending the results of the fungal

• culture.

• Be in good health and free of any disease or physical condition which might, in theInvestigator's opinion, expose the subject to an unacceptable risk by studyparticipation.

• Females must be non-pregnant (confirmed by a negative urine pregnancy test (UPT) atbaseline), non-lactating and not intending to become pregnant during the course of thestudy.

Exclusion Criteria:

• Is pregnant nursing or planning a pregnancy during the study.

• Has used topical antifungals or topical corticosteroids on the feet within 30 daysprior to the start of the study.

• Has received systemic antifungal therapy within 12 weeks prior to the start of thestudy medication.

• Has used systemic antibacterials or systemic corticosteroids within 30 days prior tothe start of the study. Systemic corticosteroids do not include intranasal, inhaled,and ophthalmic corticosteroids used for the management of allergies, pulmonarydisorders or other conditions.

• Has a history of uncontrolled diabetes mellitus or is immunocompromised (due todisease, e.g., HIV, or medications).

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

• Onychomycosis, involving ≥ 20% of the area of either great toenail or involvement ofmore 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 devicewithin 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.