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

Phase 1

Completed

• Conditions: Tinea Pedis
• Interventions: Drug: Oxiconazole Nitrate Cream 1%; Drug: Oxiconazole Nitrate Cream 1% (Oxistat®); Drug: Placebo

• Registration Number: NCT01519752
• Lead Sponsor: Taro Pharmaceuticals USA

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-01-19
• Study First Submitted QC: 2012-01-24
• Study First Posted: 2012-01-27
• Primary Completion: 2012-08
• Study Completion: 2012-11
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-19
• Last Update Posted: 2014-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 661

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxiconazole Nitrate Cream 1%	Oxiconazole Nitrate Cream 1%	-
Oxiconazole Nitrate Cream 1% (Oxistat®)	Oxiconazole Nitrate Cream 1% (Oxistat®)	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Therapeutic Cure	Day 42	Clinical \& Mycological Cure at 6 weeks

Secondary Outcome Measures

Name	Time	Method
Clinical Cure	Day 42	Proportion of patients considered a clinical cure at 6 weeks
Mycological Cure	Day 42	Proportion of patients with both KOH \& culture negative at 6 weeks