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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT01519752
First received: January 19, 2012
Last updated: January 19, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Tinea Pedis
Drug: Oxiconazole Nitrate Cream 1%
Drug: Oxiconazole Nitrate Cream 1% (Oxistat®)
Drug: Placebo
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Taro Pharmaceuticals USA:

Primary Outcome Measures:
  • Therapeutic Cure [ Time Frame: Day 42 ] [ Designated as safety issue: No ]
    Clinical & Mycological Cure at 6 weeks


Secondary Outcome Measures:
  • Clinical Cure [ Time Frame: Day 42 ] [ Designated as safety issue: No ]
    Proportion of patients considered a clinical cure at 6 weeks

  • Mycological Cure [ Time Frame: Day 42 ] [ Designated as safety issue: No ]
    Proportion of patients with both KOH & culture negative at 6 weeks


Enrollment: 661
Study Start Date: November 2011
Study Completion Date: November 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: Placebo Drug: Placebo
Placebo applied to affected area once a day for 28 days

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT01519752     History of Changes
Other Study ID Numbers: OXZC 1102
Study First Received: January 19, 2012
Last Updated: January 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Taro Pharmaceuticals USA:
Tinea Pedis

Additional relevant MeSH terms:
Tinea
Tinea Pedis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Foot Dermatoses
Foot Diseases
Pruritus
Skin Manifestations
Signs and Symptoms
Oxiconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014