BE Study of Naftifine HCL
BE Study of Naftifine HCL
The current study was randomized, double blind, placebo-controlled, prospective, multicenter,
 comparative therapeutic equivalence study.

 The study duration for each patient was 6 weeks: Following were the visit details.

 V1-Baseline and Randomization Visit (Day 1). V2- End of therapy visit (at the end of week 2 +
 2 days). V3- Follow up visit (at the end of week 4 + 2 days). V4 - Test of cure visit ( at
 the end of week 6 + 4 days).
Inclusion Criteria:

 1. Healthy males and females aged more than or equal to 18 years

 2. 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)

 3. 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:

 1. Pregnant or lactating or planning to become pregnant during the study period

 2. Use of antipruritics, including antihistamines, within 72 hours prior to entry into
 the study

 3. Use of topical corticosteroid, antibiotics or antifungal therapy within 2 weeks prior
 to entry into the study

 4. Use of systemic (e.g., oral or injectable) corticosteroid, antibiotics or antifungal
 therapy within 1 month prior to entry into the study

 5. Use of oral terbinafine or itraconazole within 2 months prior to entry into the study

 6. Use of immunosuppressive medication or radiation therapy within 3 months prior to
 entry into the study.

 7. Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.

 8. Presence of any other infection of the foot or other disease process that might
 confound the treatment evaluation

 9. History of dermatophyte infections unresponsive to systemic or topical antifungal
 drugs

 10. Known hypersensitivity to Naftifine Hydrochloride or to any component of the
 formulation