BE Study of Naftifine HCL

Inclusion criteria

• Healthy males and females aged more than or equal to 18 years
• Clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot (the non-interdigital lesions should not be hyperkeratotic, i.e., characteristic of tinea pedis moccasin), and provisionally confirmed at baseline by a positive potassium hydroxide (KOH) wet mount preparation (i.e., skin scrapings from the target site are placed on a microscope slide with a drop of 10% KOH, and microscopic examination reveals segmented fungal hyphae)
• The sum of the clinical signs and symptoms scores of the target lesion is at least 4, including a minimum score of at least 2 for erythema AND a minimum score of 2 for either scaling or pruritus (on a scale of 0-3, where 2 indicates moderate severity)

Exclusion criteria

• Pregnant or lactating or planning to become pregnant during the study period
• Use of antipruritics, including antihistamines, within 72 hours prior to entry into the study
• Use of topical corticosteroid, antibiotics or antifungal therapy within 2 weeks prior to entry into the study
• Use of systemic (e.g., oral or injectable) corticosteroid, antibiotics or antifungal therapy within 1 month prior to entry into the study
• Use of oral terbinafine or itraconazole within 2 months prior to entry into the study
• Use of immunosuppressive medication or radiation therapy within 3 months prior to entry into the study.
• Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.
• Presence of any other infection of the foot or other disease process that might confound the treatment evaluation
• History of dermatophyte infections unresponsive to systemic or topical antifungal drugs
• Known hypersensitivity to Naftifine Hydrochloride or to any component of the formulation