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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00835510
First received: January 30, 2009
Last updated: January 2, 2014
Last verified: January 2014
  Purpose

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).


Condition Intervention Phase
Tinea Pedis
Drug: Butenafine cream 1% manufactured by Taro
Drug: Lotrimin Ultra (butenafine) 1%
Drug: Butenafine Vehicle manufactured by Taro
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Taro Pharmaceuticals USA:

Primary Outcome Measures:
  • Therapeutic Cure - Superiority Analysis [ Time Frame: 42 days ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    Patient was cured both by symptoms (Clinical Cure) and by the results of fungal testing (Mycological Cure).


Secondary Outcome Measures:
  • Therapeutic Cure [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Subject with clinical and mycological cure at day 7

  • Mycologic Cure [ Time Frame: 42 days ] [ Designated as safety issue: No ]
    Negative KOH and fungal culture at day 42

  • Clinical Cure [ Time Frame: 42 days ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]

Enrollment: 548
Study Start Date: June 2008
Study Completion Date: December 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Butenafine cream 1% (Taro)
Butenafine cream manufactured by Taro applied for 7 days
Drug: Butenafine cream 1% manufactured by Taro
Treatment applied to affected area twice daily for 7 days
Active Comparator: Lotrimin Ultra (butenafine) 1%
Lotrimin Ultra (butenafine) applied for 7 days
Drug: Lotrimin Ultra (butenafine) 1%
Treatment applied to affected area twice daily for 7 days
Placebo Comparator: Vehicle
Butenafine vehicle applied for 7 days
Drug: Butenafine Vehicle manufactured by Taro
Treatment applied to affected area twice daily for 7 days

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00835510

Locations
United States, California
Investigator Site
Burbank, California, United States
Investigator Site
San Diego, California, United States
United States, Florida
Investigator Site
Miami, Florida, United States
United States, Georgia
Investigator Site
Martinez, Georgia, United States
Investigator Site
Stockbridge, Georgia, United States
United States, Michigan
Investigator Site
Clinton Township, Michigan, United States
United States, North Carolina
Investigator Site
Hickory, North Carolina, United States
Investigator Site
Raleigh, North Carolina, United States
Investigator Site
Salisbury, North Carolina, United States
United States, Ohio
Investigator Site
Sylvania, Ohio, United States
United States, South Carolina
Investigator Site
Simpsonville, South Carolina, United States
United States, Tennessee
Investigator Site
Bristol, Tennessee, United States
Investigator Site
Nashville, Tennessee, United States
United States, Texas
Investigator Site
College Station, Texas, United States
Investigator Site
Houston, Texas, United States
Investigator Site
San Antonio, Texas, United States
Belize
Investigator Site
Belize City, Belize
Sponsors and Collaborators
Taro Pharmaceuticals USA
  More Information

No publications provided

Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT00835510     History of Changes
Other Study ID Numbers: BTNF-0708
Study First Received: January 30, 2009
Results First Received: May 4, 2009
Last Updated: January 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Taro Pharmaceuticals USA:
Tinea pedis

Additional relevant MeSH terms:
Tinea
Tinea Pedis
Dermatomycoses
Foot Dermatoses
Foot Diseases
Infection
Mycoses
Pruritus
Signs and Symptoms
Skin Diseases
Skin Diseases, Infectious
Skin Manifestations
Butenafine
Miconazole
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014