A Therapeutic Equivalence Study of Two Oxiconazole Nitrate Topical Cream Treatments for Patients With Tinea Pedis



Status:Completed
Conditions:Podiatry
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:Any
Updated:9/23/2012
Start Date:December 2011
End Date:September 2012
Contact:Gail Gongas
Email:GDGongas@novumprs.com

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A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multiple-Site, Study Comparing Oxiconazole Nitrate Cream 1% (Taro Pharmaceuticals,Inc) to Oxistat® (Oxiconazole Nitrate Cream) Cream 1% (PharmaDerma) in the Treatment of 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.
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Long Beach, California 90806
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6699 Alvarado Rd.
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