NCT00835510

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
548

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_1

Geographic Reach
2 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 3, 2009

Completed
8 months until next milestone

Results Posted

Study results publicly available

October 6, 2009

Completed
Last Updated

February 4, 2014

Status Verified

January 1, 2014

Enrollment Period

4 months

First QC Date

January 30, 2009

Results QC Date

May 4, 2009

Last Update Submit

January 2, 2014

Conditions

Tinea Pedis

Keywords

Tinea pedis

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Therapeutic Cure

    7 days

  • Mycologic Cure

    42 days

  • Clinical Cure

    42 days

  • Safety and Adverse Event Profile

    42 days

Study Arms (3)

Butenafine cream 1% (Taro)

EXPERIMENTAL

Butenafine cream manufactured by Taro applied for 7 days

Drug: Butenafine cream 1% manufactured by Taro

Lotrimin Ultra (butenafine) 1%

ACTIVE COMPARATOR

Lotrimin Ultra (butenafine) applied for 7 days

Drug: Lotrimin Ultra (butenafine) 1%

Vehicle

PLACEBO COMPARATOR

Butenafine vehicle applied for 7 days

Drug: Butenafine Vehicle manufactured by Taro

Interventions

Butenafine cream 1% manufactured by TaroDRUG

Treatment applied to affected area twice daily for 7 days

Butenafine cream 1% (Taro)
Lotrimin Ultra (butenafine) 1%DRUG

Treatment applied to affected area twice daily for 7 days

Lotrimin Ultra (butenafine) 1%
Butenafine Vehicle manufactured by TaroDRUG

Treatment applied to affected area twice daily for 7 days

Vehicle

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Investigator Site

Burbank, California, United States

Location

Investigator Site

San Diego, California, United States

Location

Investigator Site

Miami, Florida, United States

Location

Investigator Site

Martinez, Georgia, United States

Location

Investigator Site

Stockbridge, Georgia, United States

Location

Investigator Site

Clinton Township, Michigan, United States

Location

Investigator Site

Hickory, North Carolina, United States

Location

Investigator Site

Raleigh, North Carolina, United States

Location

Investigator Site

Salisbury, North Carolina, United States

Location

Investigator Site

Sylvania, Ohio, United States

Location

Investigator Site

Simpsonville, South Carolina, United States

Location

Investigator Site

Bristol, Tennessee, United States

Location

Investigator Site

Nashville, Tennessee, United States

Location

Investigator Site

College Station, Texas, United States

Location

Investigator Site

Houston, Texas, United States

Location

Investigator Site

San Antonio, Texas, United States

Location

Investigator Site

Belize City, Belize

Location

MeSH Terms

Conditions

Tinea Pedis

Interventions

butenafine

Condition Hierarchy (Ancestors)

TineaDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousFoot DermatosesFoot DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPruritusSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Medical Director
Organization
Taro Pharmaceuticals
medical.affairs@taro.com
(914) 345-9001

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2009

First Posted

February 3, 2009

Study Start

June 1, 2008

Primary Completion

October 1, 2008

Study Completion

December 1, 2008

Last Updated

February 4, 2014

Results First Posted

October 6, 2009

Record last verified: 2014-01

Locations

US(16)BE(1)