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

Information source: Taro Pharmaceuticals USA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tinea Pedis

Intervention: Oxiconazole Nitrate Cream 1% (Drug); Oxiconazole Nitrate Cream 1% (Oxistat®) (Drug); Placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Taro Pharmaceuticals USA

Summary

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Therapeutic Cure

Secondary outcome:

Clinical Cure

Mycological Cure

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Additional Information

Starting date: November 2011
Last updated: January 19, 2014

Page last updated: August 23, 2015

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