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

 
Original Study ID : BTNF-0708
NCT ID : NCT00835510
Brief Title : Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis
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
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).
Source : Taro Pharmaceuticals USA
Overall Status : Completed
Start Date : June 2008
End Date : December 2008
Completion Date : December 2008
Official Title : Phase 3
Phase : Interventional
Study Design : Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Bio-equivalence Study
Enrollment : 500
Verification Date : January 2009
First Received Date : January 30, 2009
Trial Eligibility
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, 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 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 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.
Gender : Both
Minimum Age : 12 Years
Maximum Age : N/A
Healthy Volunteers : No
Facilities
Facility Name : San Diego Sports Medicine and Family Health Center
City : San Diego
State : California
Country : United States
Facility Name : Providence Clinical Research
City : Burbank
State : California
Country : United States
Facility Name : FXM Research Corp.
City : Miami
State : Florida
Country : United States
Facility Name : International Dermatology Research, Inc.
City : Miami
State : Florida
Country : United States
Facility Name : Medical Parameters
City : Martinez
State : Georgia
Country : United States
Facility Name : Clinical Research Atlanta
City : Stockbridge
State : Georgia
Country : United States
Facility Name : Michigan Center for Skin Care Research Corp.
City : Clinton Township
State : Michigan
Country : United States
Facility Name : Unifour Medical Research Associates
City : Hickory
State : North Carolina
Country : United States
Facility Name : Crescent Medical Research
City : Salisbury
State : North Carolina
Country : United States
Facility Name : Triangle Medical Research
City : Raleigh
State : North Carolina
Country : United States
Facility Name : Toledo Center for Clinical Research
City : Sylvania
State : Ohio
Country : United States
Facility Name : Palmetto Clinical Trial Services, LLC
City : Simpsonville
State : South Carolina
Country : United States
Facility Name : Dermatology Research Association
City : Nashville
State : Tennessee
Country : United States
Facility Name : TN Clinical Research Center
City : Nashville
State : Tennessee
Country : United States
Facility Name : TriCities Medical Research
City : Bristol
State : Tennessee
Country : United States
Facility Name : J & S Studies, Inc.
City : College Station
State : Texas
Country : United States
Facility Name : Endeavor Clinical Research
City : San Antonio
State : Texas
Country : United States
Facility Name : San Antonio Podiatry Associates, P.C.
City : San Antonio
State : Texas
Country : United States
Facility Name : West Houston Clinical Research Services
City : Houston
State : Texas
Country : United States
Facility Name : FXM Research International
City : Belize City
State : Texas
Country : Belize
Facility Name : FXM Research International
City : Belize City
State : Texas
Country : Belize
 
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