Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis
NCT ID: NCT00835510
Last Updated: 2014-02-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
548 participants
INTERVENTIONAL
2008-06-30
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Butenafine cream 1% (Taro)
Butenafine cream manufactured by Taro applied for 7 days
Butenafine cream 1% manufactured by Taro
Treatment applied to affected area twice daily for 7 days
Lotrimin Ultra (butenafine) 1%
Lotrimin Ultra (butenafine) applied for 7 days
Lotrimin Ultra (butenafine) 1%
Treatment applied to affected area twice daily for 7 days
Vehicle
Butenafine vehicle applied for 7 days
Butenafine Vehicle manufactured by Taro
Treatment applied to affected area twice daily for 7 days
Interventions
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Butenafine cream 1% manufactured by Taro
Treatment applied to affected area twice daily for 7 days
Lotrimin Ultra (butenafine) 1%
Treatment applied to affected area twice daily for 7 days
Butenafine Vehicle manufactured by Taro
Treatment applied to affected area twice daily for 7 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
12 Years
ALL
No
Sponsors
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Sun Pharmaceutical Industries, Inc.
INDUSTRY
Responsible Party
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Locations
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Investigator Site
Burbank, California, United States
Investigator Site
San Diego, California, United States
Investigator Site
Miami, Florida, United States
Investigator Site
Martinez, Georgia, United States
Investigator Site
Stockbridge, Georgia, United States
Investigator Site
Clinton Township, Michigan, United States
Investigator Site
Hickory, North Carolina, United States
Investigator Site
Raleigh, North Carolina, United States
Investigator Site
Salisbury, North Carolina, United States
Investigator Site
Sylvania, Ohio, United States
Investigator Site
Simpsonville, South Carolina, United States
Investigator Site
Bristol, Tennessee, United States
Investigator Site
Nashville, Tennessee, United States
Investigator Site
College Station, Texas, United States
Investigator Site
Houston, Texas, United States
Investigator Site
San Antonio, Texas, United States
Investigator Site
Belize City, , Belize
Countries
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Other Identifiers
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BTNF-0708
Identifier Type: -
Identifier Source: org_study_id
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