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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 19, 2012
First Posted Date  ICMJE January 27, 2012
Last Update Posted Date January 22, 2014
Study Start Date  ICMJE November 2011
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2012)
Therapeutic Cure [ Time Frame: Day 42 ]
Clinical & Mycological Cure at 6 weeks
Original Primary Outcome Measures  ICMJE
 (submitted: January 24, 2012)
Therapeutic Cure [ Time Frame: Day 42 ]
Clinical & Mycological Cure 2 wks after end of treatment (Day 42)
Change History Complete list of historical versions of study NCT01519752 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2012)
  • Clinical Cure [ Time Frame: Day 42 ]
    Proportion of patients considered a clinical cure at 6 weeks
  • Mycological Cure [ Time Frame: Day 42 ]
    Proportion of patients with both KOH & culture negative at 6 weeks
Original Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2012)
  • Clinical Cure [ Time Frame: Day 42 ]
    Proportion of patients considered a clinical cure at Day 42
  • Mycological Cure [ Time Frame: Day 42 ]
    Proportion of patients considered a mycological Cure at Day 42
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Therapeutic Equivalence Study of Two Oxiconazole Nitrate Topical Cream Treatments for Patients With Tinea Pedis
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Tinea Pedis
Intervention  ICMJE
  • Drug: Oxiconazole Nitrate Cream 1%
    Oxiconazole Nitrate Cream 1% applied to affected area once a day for 28 days
  • Drug: Oxiconazole Nitrate Cream 1% (Oxistat®)
    Oxiconazole Nitrate Cream 1%(Oxistat®)applied to affected area once a day for 28 days
  • Drug: Placebo
    Placebo applied to affected area once a day for 28 days
Study Arms  ICMJE
  • Experimental: Oxiconazole Nitrate Cream 1%
    Intervention: Drug: Oxiconazole Nitrate Cream 1%
  • Active Comparator: Oxiconazole Nitrate Cream 1% (Oxistat®)
    Intervention: Drug: Oxiconazole Nitrate Cream 1% (Oxistat®)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 19, 2013)
661
Original Estimated Enrollment  ICMJE
 (submitted: January 24, 2012)
625
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01519752
Other Study ID Numbers  ICMJE OXZC 1102
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Taro Pharmaceuticals USA
Study Sponsor  ICMJE Taro Pharmaceuticals USA
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Taro Pharmaceuticals USA
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP