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

Primary Purpose

Tinea Pedis

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Butenafine cream 1% manufactured by Taro
Lotrimin Ultra (butenafine) 1%
Butenafine Vehicle manufactured by Taro
Sponsored by
Taro Pharmaceuticals USA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinea Pedis focused on measuring Tinea pedis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Butenafine cream 1% (Taro)

Lotrimin Ultra (butenafine) 1%

Vehicle

Arm Description

Butenafine cream manufactured by Taro applied for 7 days

Lotrimin Ultra (butenafine) applied for 7 days

Butenafine vehicle applied for 7 days

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

Therapeutic Cure
Subject with clinical and mycological cure at day 7
Mycologic Cure
Negative KOH and fungal culture at day 42
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.
Safety and Adverse Event Profile

Full Information

First Posted
January 30, 2009
Last Updated
January 2, 2014
Sponsor
Taro Pharmaceuticals USA
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1. Study Identification

Unique Protocol Identification Number
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taro Pharmaceuticals USA

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinea Pedis
Keywords
Tinea pedis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
548 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Butenafine cream 1% (Taro)
Arm Type
Experimental
Arm Description
Butenafine cream manufactured by Taro applied for 7 days
Arm Title
Lotrimin Ultra (butenafine) 1%
Arm Type
Active Comparator
Arm Description
Lotrimin Ultra (butenafine) applied for 7 days
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Butenafine vehicle applied for 7 days
Intervention Type
Drug
Intervention Name(s)
Butenafine cream 1% manufactured by Taro
Intervention Description
Treatment applied to affected area twice daily for 7 days
Intervention Type
Drug
Intervention Name(s)
Lotrimin Ultra (butenafine) 1%
Intervention Description
Treatment applied to affected area twice daily for 7 days
Intervention Type
Drug
Intervention Name(s)
Butenafine Vehicle manufactured by Taro
Intervention Description
Treatment applied to affected area twice daily for 7 days
Primary Outcome Measure Information:
Title
Therapeutic Cure - Superiority Analysis
Description
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.
Time Frame
42 days
Title
Therapeutic Cure Non-Inferiority Comparison of Butenafine Cream and Lotrimin Ultra
Description
Patient was cured both by symptoms (Clinical Cure) and by the results of fungal testing (Mycological Cure).
Time Frame
42 days
Secondary Outcome Measure Information:
Title
Therapeutic Cure
Description
Subject with clinical and mycological cure at day 7
Time Frame
7 days
Title
Mycologic Cure
Description
Negative KOH and fungal culture at day 42
Time Frame
42 days
Title
Clinical Cure
Description
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.
Time Frame
42 days
Title
Safety and Adverse Event Profile
Time Frame
42 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Investigator Site
City
Burbank
State/Province
California
Country
United States
Facility Name
Investigator Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Investigator Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Investigator Site
City
Martinez
State/Province
Georgia
Country
United States
Facility Name
Investigator Site
City
Stockbridge
State/Province
Georgia
Country
United States
Facility Name
Investigator Site
City
Clinton Township
State/Province
Michigan
Country
United States
Facility Name
Investigator Site
City
Hickory
State/Province
North Carolina
Country
United States
Facility Name
Investigator Site
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Investigator Site
City
Salisbury
State/Province
North Carolina
Country
United States
Facility Name
Investigator Site
City
Sylvania
State/Province
Ohio
Country
United States
Facility Name
Investigator Site
City
Simpsonville
State/Province
South Carolina
Country
United States
Facility Name
Investigator Site
City
Bristol
State/Province
Tennessee
Country
United States
Facility Name
Investigator Site
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Investigator Site
City
College Station
State/Province
Texas
Country
United States
Facility Name
Investigator Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Investigator Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Investigator Site
City
Belize City
Country
Belize

12. IPD Sharing Statement

Learn more about this trial

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

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