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

Tinea Pedis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01519752
• Other study ID #: OXZC 1102
• Status: Completed
• Phase: Phase 1
• First received: January 19, 2012
• Last updated: January 19, 2014
• Start date: November 2011
• Est. completion date: November 2012

Study information

• Verified date: January 2014
• Source: Taro Pharmaceuticals USA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 661
• Est. completion date: November 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Tinea
• Tinea Pedis

Intervention

Drug:
• Oxiconazole Nitrate Cream 1%
Oxiconazole Nitrate Cream 1% applied to affected area once a day for 28 days
• Oxiconazole Nitrate Cream 1% (Oxistat®)
Oxiconazole Nitrate Cream 1%(Oxistat®)applied to affected area once a day for 28 days
• Placebo
Placebo applied to affected area once a day for 28 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taro Pharmaceuticals USA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapeutic Cure	Clinical & Mycological Cure at 6 weeks	Day 42	No
Secondary	Clinical Cure	Proportion of patients considered a clinical cure at 6 weeks	Day 42	No
Secondary	Mycological Cure	Proportion of patients with both KOH & culture negative at 6 weeks	Day 42	No