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

Tinea Pedis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00835510
• Other study ID #: BTNF-0708
• Status: Completed
• Phase: Phase 1
• First received: January 30, 2009
• Last updated: January 2, 2014
• Start date: June 2008
• Est. completion date: December 2008

Study information

• Verified date: January 2014
• Source: Taro Pharmaceuticals USA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 548
• Est. completion date: December 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Tinea
• Tinea Pedis

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Belize	Investigator Site	Belize City
United States	Investigator Site	Bristol	Tennessee
United States	Investigator Site	Burbank	California
United States	Investigator Site	Clinton Township	Michigan
United States	Investigator Site	College Station	Texas
United States	Investigator Site	Hickory	North Carolina
United States	Investigator Site	Houston	Texas
United States	Investigator Site	Martinez	Georgia
United States	Investigator Site	Miami	Florida
United States	Investigator Site	Nashville	Tennessee
United States	Investigator Site	Raleigh	North Carolina
United States	Investigator Site	Salisbury	North Carolina
United States	Investigator Site	San Antonio	Texas
United States	Investigator Site	San Diego	California
United States	Investigator Site	Simpsonville	South Carolina
United States	Investigator Site	Stockbridge	Georgia
United States	Investigator Site	Sylvania	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Taro Pharmaceuticals USA

Countries where clinical trial is conducted

United States,  Belize, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapeutic Cure - Superiority Analysis	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.	42 days	No
Primary	Therapeutic Cure Non-Inferiority Comparison of Butenafine Cream and Lotrimin Ultra	Patient was cured both by symptoms (Clinical Cure) and by the results of fungal testing (Mycological Cure).	42 days	No
Secondary	Therapeutic Cure	Subject with clinical and mycological cure at day 7	7 days	No
Secondary	Mycologic Cure	Negative KOH and fungal culture at day 42	42 days	No
Secondary	Clinical Cure	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; = Mild - obvious but minimal involvement; = Moderate - something that is easily noted; = 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.	42 days	No
Secondary	Safety and Adverse Event Profile		42 days	Yes