Clinical Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% in the Treatment of Tinea Pedis

Exclusion Criteria

• •1. Females who are pregnant, lactating or planning to become pregnant during the study period.
• •2. History of or current psoriasis, Lichen planus or contact dermatitis involving the feet within the previous 12 months.
• •3. History of dermatophyte infections with a lack of response to antifungal therapy (recurrent tinea pedis \[i.e., more than 3 infections in the past 12 months\] that were unresponsive to previous antifungal therapy).
• •4. History of allergy, hypersensitivity, or intolerance to ketoconazole, other imidazoles, sulfites or any other component of the study product.
• •5. Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.
• •6. Current uncontrolled diabetes.
• •7. Presence of any other infection of the foot or other disease process that, in the Investigator's opinion, may interfere with the evaluation of the patient's tinea pedis.
• •8. Known history of or current impaired wound healing, presence of peripheral vascular disease and/or trophic changes of the lower limbs to an extent that, in the opinion of the Investigator, would make the patient unsuitable for the study or compromise patient's safety.
• •9. Significant history or current evidence of chronic infectious disease, system disorder, organ disorder, immunosuppression (due to disease or therapy, including history of organ transplant), or other medical condition that, in the Investigator's opinion, would place the patient at undue risk by participating or compromise the integrity of the study data.
• •10. Use of antipruritics, including antihistamines, within 72 hours before Visit 1.
• •11. Use of topical corticosteroids, topical antibiotics or topical antifungal therapy (e.g., clotrimazole, econazole, fluconazole) within 2 weeks before Visit 1.
• •12. Use of systemic (e.g., oral or injectable) antibiotics, systemic antifungal therapy, or systemic corticosteroids within 30 days before Visit 1. The use of intranasal, inhaled or ophthalmic corticosteroids for acute or chronic conditions (e.g., allergic conjunctivitis, asthma/chronic obstructive pulmonary disease maintenance) is acceptable to the extent that, in the opinion of the Investigator, does not compromise safety of patient or integrity of data.
• •13. Use of oral terbinafine or itraconazole within 2 months before Visit 1.
• •14. Use of immunosuppressive medication or radiation therapy within 3 months before Visit 1.
• •15. Receipt of any drug as part of a research study within 30 days before Visit 1.
• •16. Previous participation in this study.
• •17. Employee of the Investigator or research center or their immediate family members.
• •18. Inability to understand the requirements of the study and the relative information or are unable or unwilling to comply with the study protocol.