A Trial of Safety/Efficacy of Test Article in Patients With Interdigital T. Pedis

Inclusion criteria

• ✓. A signed approved informed consent form by Institutional Review Board/Independent Ethics Committee.
• ✓. A signed Health Information Portability and Accountability Act (HIPAA) authorization form which permits the use and disclosure of subject's individually identifiable health information.
• ✓. Male or Female Subjects of any race 18 years of age and older.
• ✓. Women patients of child-bearing potential must: a. Have negative urine pregnancy tests prior to study treatment to rule out pregnancy, and b. Use at least one method of birth control that results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner for the duration of study participation.
• ✓. Subjects with a clinical diagnosis of interdigital T. pedis T. pedis interdigital defined as 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).
• ✓. Provisionally confirmed diagnosis at screening by a positive potassium hydroxide (KOH) wet mount at the clinical site.
• ✓. A positive dermatophyte culture from the sample obtained at the screening visit.
• ✓. The sum of the clinical signs and symptoms scores of at least one web space (Target web space) is at least 4 using the Grading of Signs and Symptoms of T. pedis including a minimum score of at least 2 for erythema AND a minimum score of 2 for either scaling/fissures or pruritus/burning (on a scale of 0-3, where 2 indicates moderate severity).

Exclusion criteria