Clinical trial NCT00835510: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tinea Pedis
Keywords: Tinea pedis
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2009-02-03
Enrollment: 548
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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, 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.

Primary outcomes:
measure: Therapeutic Cure - Superiority Analysis
timeFrame: 42 days
measure: Therapeutic Cure Non-Inferiority Comparison of Butenafine Cream and Lotrimin Ultra
timeFrame: 42 days
Secondary outcomes:
measure: Therapeutic Cure
timeFrame: 7 days
measure: Mycologic Cure
timeFrame: 42 days
measure: Clinical Cure
timeFrame: 42 days
measure: Safety and Adverse Event Profile
timeFrame: 42 days
Other outcomes:
Locations:
city: Burbank
country: United States
facility: Investigator Site
state: California
city: San Diego
country: United States
facility: Investigator Site
state: California
city: Miami
country: United States
facility: Investigator Site
state: Florida
city: Martinez
country: United States
facility: Investigator Site
state: Georgia
city: Stockbridge
country: United States
facility: Investigator Site
state: Georgia
city: Clinton Township
country: United States
facility: Investigator Site
state: Michigan
city: Hickory
country: United States
facility: Investigator Site
state: North Carolina
city: Raleigh
country: United States
facility: Investigator Site
state: North Carolina
city: Salisbury
country: United States
facility: Investigator Site
state: North Carolina
city: Sylvania
country: United States
facility: Investigator Site
state: Ohio
city: Simpsonville
country: United States
facility: Investigator Site
state: South Carolina
city: Bristol
country: United States
facility: Investigator Site
state: Tennessee
city: Nashville
country: United States
facility: Investigator Site
state: Tennessee
city: College Station
country: United States
facility: Investigator Site
state: Texas
city: Houston
country: United States
facility: Investigator Site
state: Texas
city: San Antonio
country: United States
facility: Investigator Site
state: Texas
city: Belize City
country: Belize
facility: Investigator Site
Study officials:
References: