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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Tinea Pedis

Intervention / Treatment
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* Drug: Oxiconazole Nitrate Cream 1%
* Drug: Oxiconazole Nitrate Cream 1% (Oxistat®)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or non-pregnant, non-lactating female, 12 years of age or older. Signed informed consent form, which meets all criteria of current FDA regulations 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} 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). The presence of tinea pedis infection, confirm by the observation of segmented fungal hyphae during a microscopic KOH wet mount examination. Exclusion Criteria: Females who are pregnant, or lactating or likely to become pregnant during the study. Any known hypersensitivity to oxiconazole nitrate or other antifungal agents. 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). Participation in a research study in the past 30 days prior to screening/randomization.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxiconazole Nitrate Cream 1%<br> | Drug: Oxiconazole Nitrate Cream 1%<br>* Oxiconazole Nitrate Cream 1% applied to affected area once a day for 28 days<br>|
| Active Comparator: Oxiconazole Nitrate Cream 1% (Oxistat®)<br> | Drug: Oxiconazole Nitrate Cream 1% (Oxistat®)<br>* Oxiconazole Nitrate Cream 1%(Oxistat®)applied to affected area once a day for 28 days<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo applied to affected area once a day for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutic Cure | Clinical & Mycological Cure at 6 weeks | Day 42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Cure | Proportion of patients considered a clinical cure at 6 weeks | Day 42 | 
| Mycological Cure | Proportion of patients with both KOH & culture negative at 6 weeks | Day 42 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tinea Pedis