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

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

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).

Study Overview

• Status: Completed
• Conditions: Tinea Pedis
• Intervention / Treatment: Drug: Butenafine cream 1% manufactured by Taro; Drug: Lotrimin Ultra (butenafine) 1%; Drug: Butenafine Vehicle manufactured by Taro

• Study Type: Interventional
• Enrollment (Actual): 548
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapeutic Cure	Subject with clinical and mycological cure at day 7	7 days
Mycologic Cure	Negative KOH and fungal culture at day 42	42 days
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
Safety and Adverse Event Profile		42 days

Collaborators and Investigators

• Sponsor: Taro Pharmaceuticals USA

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (ACTUAL): October 1, 2008
• Study Completion (ACTUAL): December 1, 2008

Study Registration Dates

• First Submitted: January 30, 2009
• First Submitted That Met QC Criteria: January 30, 2009
• First Posted (ESTIMATE): February 3, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): February 4, 2014
• Last Update Submitted That Met QC Criteria: January 2, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Tinea pedis
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Foot Diseases; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Skin Manifestations; Dermatomycoses; Foot Dermatoses; Pruritus; Tinea; Tinea Pedis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Clotrimazole; Butenafine
• Other Study ID Numbers: BTNF-0708