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

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.

Study Overview

• Status: Completed
• Conditions: Tinea Pedis
• Intervention / Treatment: Drug: Oxiconazole Nitrate Cream 1%; Drug: Oxiconazole Nitrate Cream 1% (Oxistat®); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 661
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Taro Pharmaceuticals USA

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: January 19, 2012
• First Submitted That Met QC Criteria: January 24, 2012
• First Posted (Estimate): January 27, 2012

Study Record Updates

• Last Update Posted (Estimate): January 22, 2014
• Last Update Submitted That Met QC Criteria: January 19, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Tinea Pedis
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Foot Diseases; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Skin Manifestations; Dermatomycoses; Foot Dermatoses; Pruritus; Tinea; Tinea Pedis; Anti-Infective Agents; Antifungal Agents; Oxiconazole
• Other Study ID Numbers: OXZC 1102