A Therapeutic Equivalence Study of Two Oxiconazole Nitrate Topical Cream Treatments for Patients With Tinea Pedis
A Therapeutic Equivalence Study of Two Oxiconazole Nitrate Topical Cream Treatments for Patients With Tinea Pedis
The objective of this study is to demonstrate that Oxiconazole nitrate 1% topical cream is
 effective for the treatment of patients with moderate to severe Tinea pedis.
Inclusion Criteria:

 1. Male or non-pregnant, non-lactating female, 12 years of age or older.

 2. Signed informed consent form, which meets all criteria of current FDA regulations

 3. If female and of child bearing potential, prepare to abstain from sexual intercourse
 or use a reliable method of contraception during the study {e.g., condom, IUD, oral,
 transdermal, injected or implanted hormonal contraceptives)and (must have used the
 same product for at least 30 days prior to the study start and use the same product
 throughout the duration of the study), transdermal or implanted hormonal
 contraceptives}

 4. A confirmed 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 moccasin).

 5. The presence of tinea pedis infection, confirm by the observation of segmented fungal
 hyphae during a microscopic KOH wet mount examination.

 Exclusion Criteria:

 1. Females who are pregnant, or lactating or likely to become pregnant during the study.

 2. Any known hypersensitivity to oxiconazole nitrate or other antifungal agents.

 3. Patients with a past history of tinea pedis infections with a lack of response to
 antifungal therapy (i.e. recurrent tinea pedis, more than 3 infections in the past 12
 months, which were unresponsive to previous antifungal therapy).

 4. Participation in a research study in the past 30 days prior to
 screening/randomization.