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

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ClinicalTrials.gov Identifier: NCT01519752
Recruitment Status : Completed
First Posted : January 27, 2012
Last Update Posted : January 22, 2014
Sponsor:
Information provided by (Responsible Party):
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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 661 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : November 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Therapeutic Cure [ Time Frame: Day 42 ]
    Clinical & Mycological Cure at 6 weeks


Secondary Outcome Measures :
  1. Clinical Cure [ Time Frame: Day 42 ]
    Proportion of patients considered a clinical cure at 6 weeks

  2. Mycological Cure [ Time Frame: Day 42 ]
    Proportion of patients with both KOH & culture negative at 6 weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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.

Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT01519752     History of Changes
Other Study ID Numbers: OXZC 1102
First Posted: January 27, 2012    Key Record Dates
Last Update Posted: January 22, 2014
Last Verified: January 2014

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