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Trial record 25 of 27 for:    Clotrimazole AND Fungal Infections

Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis

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ClinicalTrials.gov Identifier: NCT00835510
Recruitment Status : Completed
First Posted : February 3, 2009
Results First Posted : October 6, 2009
Last Update Posted : February 4, 2014
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA

Tracking Information
First Submitted Date  ICMJE January 30, 2009
First Posted Date  ICMJE February 3, 2009
Results First Submitted Date  ICMJE May 4, 2009
Results First Posted Date  ICMJE October 6, 2009
Last Update Posted Date February 4, 2014
Study Start Date  ICMJE June 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2014)
  • Therapeutic Cure - Superiority Analysis [ Time Frame: 42 days ]
    Therapeutic Cure requires both Clinical Cure and Mycological Cure. Clinical Cure was based on the following signs and symptoms: fissuring, erythema, maceration, vesiculation, scaling, exudation, pruritus, burning. Each clinical symptom was evaluated using a 0-3 point rating scale: none=0, mild=1, moderate=2 or severe=3. If the score for erythema was ≤ 2 and the sum for all of the other 7 signs and symptoms was <2 then the patient was considered a Clinical Cure. Mycological Cure: The potassium hydroxide (KOH) and the fungal culture were both negative.
  • Therapeutic Cure Non-Inferiority Comparison of Butenafine Cream and Lotrimin Ultra [ Time Frame: 42 days ]
    Patient was cured both by symptoms (Clinical Cure) and by the results of fungal testing (Mycological Cure).
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2009)
Therapeutic cure (mycologic and clinical) [ Time Frame: 42 days ]
Change History Complete list of historical versions of study NCT00835510 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2014)
  • Therapeutic Cure [ Time Frame: 7 days ]
    Subject with clinical and mycological cure at day 7
  • Mycologic Cure [ Time Frame: 42 days ]
    Negative KOH and fungal culture at day 42
  • Clinical Cure [ Time Frame: 42 days ]
    The following 8 signs and symptoms are rated at each visit: Erythema Fissuring Maceration Vesiculation Desquamation/scaling Exudation Pruritus Stinging/Burning Each symptom is evaluated using the following scale: 0 = None- Complete absence of any sign or symptom
    1. = Mild - obvious but minimal involvement
    2. = Moderate - something that is easily noted
    3. = Severe - quite marked
    Clinical cure is defined as a score of 2 (moderate) or less for erythema and a total score for seven other signs and symptoms less than 2.
  • Safety and Adverse Event Profile [ Time Frame: 42 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2009)
  • Therapeutic Cure [ Time Frame: 7 days ]
  • Mycologic Cure [ Time Frame: 42 days ]
  • Clinical Cure [ Time Frame: 42 days ]
  • Safety and Adverse Event Profile [ Time Frame: 42 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis
Official Title  ICMJE A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multiple-Site Study to Evaluate the Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis
Brief Summary To demonstrate comparable safety and efficacy of Taro Pharmaceuticals Inc. butenafine hydrochloride cream 1% (test product) and Lotrimin Ultra® cream (reference listed drug) in the treatment of interdigital tinea pedis, and to show the superiority of the active treatments over that of the placebo (vehicle).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Tinea Pedis
Intervention  ICMJE
  • Drug: Butenafine cream 1% manufactured by Taro
    Treatment applied to affected area twice daily for 7 days
  • Drug: Lotrimin Ultra (butenafine) 1%
    Treatment applied to affected area twice daily for 7 days
  • Drug: Butenafine Vehicle manufactured by Taro
    Treatment applied to affected area twice daily for 7 days
Study Arms  ICMJE
  • Experimental: Butenafine cream 1% (Taro)
    Butenafine cream manufactured by Taro applied for 7 days
    Intervention: Drug: Butenafine cream 1% manufactured by Taro
  • Active Comparator: Lotrimin Ultra (butenafine) 1%
    Lotrimin Ultra (butenafine) applied for 7 days
    Intervention: Drug: Lotrimin Ultra (butenafine) 1%
  • Placebo Comparator: Vehicle
    Butenafine vehicle applied for 7 days
    Intervention: Drug: Butenafine Vehicle manufactured by Taro
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: September 3, 2009)
548
Original Actual Enrollment  ICMJE
 (submitted: January 30, 2009)
500
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Microbiologically confirmed clinical diagnosis of interdigital tinea pedis
  • 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, intra-uterine device (IUD), oral, transdermal, injected or implanted hormonal contraceptives).
  • A confirmed clinical diagnosis of interdigital tinea pedis. Lesions are to be predominately interdigital but may extend to other areas of the foot (the non-interdigital lesions must not be hyperkeratotic).
  • The presence of tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic potassium hydroxide (KOH) wet mount examination (potassium hydroxide mount preparation).
  • Identification of an appropriate dermatophyte by culture sent to the central laboratory. The appropriate dermatophytes are Trichophyton rubrum, Trichophyton mentagrophyte or Epidermophyton floccosum.

Exclusion Criteria:

  • Use of any of the following within the indicated timeline:
  • Oral or injectable steroids
  • Any oral anti-fungals within 4 weeks of the study start
  • Use of topical corticosteroids or any other topical antipruritics on the feet within 72 hours of the study start.
  • Any prescription or over-the-counter (OTC) topical antifungals on the feet within two weeks prior to study entry
  • Use of any antihistamines within 72 hours of the study start.
  • Any known hypersensitivity to butenafine or other antifungal agents.
  • Evidence of any concurrent dermatophytic infection of toe nails (onychomycosis) or other dermatological condition of the foot that may interfere with the Investigator's evaluation of tinea pedis.
  • Patients with recurrent tinea pedis (more than 3 infections in the past 12 months) who have been unresponsive to previous antifungal therapy.
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 Belize,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00835510
Other Study ID Numbers  ICMJE BTNF-0708
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