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Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital 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: NCT01580891
Recruitment Status : Completed
First Posted : April 19, 2012
Last Update Posted : May 6, 2014
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA

Tracking Information
First Submitted Date  ICMJE April 17, 2012
First Posted Date  ICMJE April 19, 2012
Last Update Posted Date May 6, 2014
Study Start Date  ICMJE May 2012
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2012)
Therapeutic Cure [ Time Frame: 42 Days ]
Patients with both mycological cure and clinical cure at the final follow-up visit two weeks fter the end of treatment (Day 42) will be considered therapeutic cures.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2012)
  • Clinical Cure [ Time Frame: 42 Days ]
    Secondary endpoints include proportion of patients considered a clinical cure at day 42.
  • Mycological Cure [ Time Frame: 42 Days ]
    Secondary endpoints will include 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 Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis
Official Title  ICMJE Randomized, Double-Blind, Placebo-Controlled, Multiple-Site, Parallel Design Study to Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis.
Brief Summary The objective of this study is to evaluate the efficacy and safety of the test formulation of Naftifine HCl Cream 1% (Taro Pharmaceuticals Inc.) as compared to the already marketed formulation Naftin® (Naftifine HCl) 1% Cream (Merz Pharmaceuticals) and placebo in patients with tinea pedis and to show the superiority of the active treatments over placebo when dosed once a day for 28 days.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Tinea Pedis
Intervention  ICMJE
  • Drug: Naftifine HCl Cream 1%
    Naftifine HCl Cream 1% applied topically once a day for 28 days.
  • Drug: Naftin® (Naftifine HCl) Cream 1%
    Naftin® (Naftifine HCl) Cream 1% applied topically once a day for 28 days.
  • Drug: Placebo topical cream
    Placebo topical cream applied topically once a day for 28 days.
Study Arms  ICMJE
  • Experimental: Naftifine HCl Cream 1%
    Naftifine HCl Cream 1% (Taro Pharmaceuticals Inc.)
    Intervention: Drug: Naftifine HCl Cream 1%
  • Active Comparator: Naftin® (Naftifine HCl) Cream 1%
    Naftin® (Naftifine HCl) Cream 1% (Merz Pharmaceuticals)
    Intervention: Drug: Naftin® (Naftifine HCl) Cream 1%
  • Placebo Comparator: Placebo topical cream
    Placebo topical cream (Taro Pharmaceuticals Inc.)
    Intervention: Drug: Placebo topical cream
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)
1053
Original Estimated Enrollment  ICMJE
 (submitted: April 18, 2012)
750
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or non-pregnant, non-lactating females 18 years of age or older.
  • Signed informed consent form, which meets all criteria of current FDA regulations.
  • If female and of child-bearing potential, have a negative urine pregnancy test at baseline visit, and prepare to abstain from sexual intercourse or use a reliable method of contraception during the study.
  • A total score of at least 4 for the clinical signs and symptoms of tinea pedis for the target lesion. In addition, the most infected area must have a minimum score of at least 2 for erythema and a minimum score of at least 2 for scaling.
  • 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 presence of tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic 10% potassium hydroxide wet mount examination.

Exclusion Criteria:

  • Females who are pregnant, lactating or likely to become pregnant during the study.
  • Use of antipruritics, including antihistamines within 72 hours prior to baseline visit.
  • Use of topical corticosteroids, antibiotics or antifungal therapies within 2 weeks prior to baseline visit.
  • Use of systemic corticosteroids, antibiotics or antifungal therapies within 1 month prior to baseline visit.
  • Use of oral terbinafine or itraconazole within 2 months prior to baseline visit.
  • Use of immunosuppressive medication or radiation therapy within 3 months prior to baseline visit.
  • Any known hypersensitivity to Naftifine HCl, any component of the formulation or other antifungal agents.
  • Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.
  • Significant history or current evidence of chronic infectious disease, system disorder, organ disorder, or other medical condition that would place the patient at undue risk by participation or could jeopardize the integrity of the study evaluations.
  • Evidence of any concurrent dermatophytic infection of the toe nails or dermatological condition of the foot that may interfere with the evaluation of tinea pedis.
  • Patients with a past history of tinea pedis infections with a lack of response to antifungal therapy.
  • Patients who would be non-compliant with the requirements of the study protocol.
  • Participation in a research study within 30 days prior to baseline visit.
  • Employees or family members of employees of the research center or investigator.
  • Previous participation in this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Belize,   United States
 
Administrative Information
NCT Number  ICMJE NCT01580891
Other Study ID Numbers  ICMJE NTFC 1105.0
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 May 2014

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