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

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.