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Efficacy, Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00443898
First Posted: March 7, 2007
Last Update Posted: May 3, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
This study is designed to assess the efficacy, safety and tolerability of a topical formulation of terbinafine solution applied daily in patients with toenail fungus. This trial will study patients with mild to moderate toenail fungus disease of the big toenail and their responses to two treatment durations, 24 or 48 weeks.

Condition Intervention Phase
Onychomycosis Drug: terbinafine Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Vehicle-controlled, Multicenter, Parallel Group Study to Assess the Efficacy, Safety, and Tolerability of Topical Terbinafine Hydrogen Chloride (HCl) Formulation for 24 or 48 Weeks of Treatment in Patients With Mild to Moderate Toenail Onychomycosis

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 24 or 48 Weeks. [ Time Frame: 52 weeks ]

    Complete cure is defined as negative KOH microscopy and negative culture for dermatophytes.

    and no residual involvement of the target toenail. The complete cure was a composite binary variable defined as "Yes" if:

    • Mycological cure (negative KOH and negative culture for dermatophytes) and
    • No residual involvement of the target toenail "No" if otherwise


Secondary Outcome Measures:
  • Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 24 or 48 Weeks. [ Time Frame: 52 weeks ]

    Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes.

    Mycological cure was a composite binary variable defined as "Yes"if :

    • Negative microscopy and
    • Negative culture for dermatophytes "No" if otherwise.

  • Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients for 24 or 48 Weeks. [ Time Frame: 52 weeks ]

    Clinical effectiveness is defined as negative KOH microscopy and negative culture for dermatophytes and <= 10% residual involvement of the target toenail.

    Clinical effectiveness was a composite binary variable defined as "Yes" if

    • Mycological cure (negative KOH and negative culture for dermatophytes) and
    • = 10% residual involvement of the target toenail "No" if otherwise

  • Number of Participants Assessed With Adverse Events and Serious Adverse Events [ Time Frame: 52 weeks ]

    An adverse event (AE) is any adverse change in health or side effect that occurs while the participant is receiving the treatment or within a previously specified period of time after the treatment has been completed.

    A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening requires, inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage.



Enrollment: 518
Study Start Date: December 2006
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
Drug: terbinafine
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 48 weeks
Other Name: Lamisil
Placebo Comparator: 2
vehicle (placebo) applied once daily for 48 weeks
Drug: Placebo
vehicle (placebo) applied once daily for 48 weeks
Experimental: 3
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
Drug: terbinafine
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 24 weeks
Other Name: Lamisil
Placebo Comparator: 4
vehicle (placebo) applied once daily for 24 weeks
Drug: Placebo
vehicle (placebo) applied once daily for 24 weeks

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and females 12 - 75 years of age
  • Fungal toenail infection of one or both of the large (great) toenails
  • The nail infection must be due to a dermatophyte, (mixed infections [dermatophyte and non-dermatophyte] are not allowed)

Exclusion Criteria:

  • Target foot must not have severe plantar (moccasin) tinea pedis that would require systemic therapy. Mild to moderate tinea pedis (athlete's foot) infection should be treated with terbinifine prior to baseline or at any time during the trial. Other topical treatments for athlete's foot may be recommended at the discretion of the investigator.
  • Subjects must not have abnormalities of the nail that could prevent a normal appearing nail if clearing of infection is achieved
  • No administration of systemic antifungal medications within 6 months prior to screening visit
  • No application of prescription topical antifungal medications for toenail fungus within 3 months or other commercially available topical medications for toenail fungus applied directly to the toenails within 1 month prior to screening visit
  • No professional pedicures or application of any nail polish product or nail cosmetic to the toenails after the screening visit
  • Known pregnancy or lactation at time of enrollment

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00443898


  Hide Study Locations
Locations
United States, Alabama
Dr. Boni Elewski
Birmingham, Alabama, United States, 35233
United States, California
Dr. Stacy Smith
San Diego, California, United States, 92123
United States, Colorado
Dr. James Swinehart
Denver, Colorado, United States, 80210
United States, Illinois
Dr. David G. Armstrong
North Chicago, Illinois, United States, 60064
United States, Maryland
Dr. Kevin Terry
Lutherville, Maryland, United States, 21093
United States, Massachusetts
Dr. Anthony Puopolo
Milford, Massachusetts, United States, 01757
United States, Minnesota
Dr. John Fenyk
Chaska, Minnesota, United States, 55318
United States, Nebraska
Dr. Joel Schlessinger
Omaha, Nebraska, United States, 68144
United States, New York
Dr. AnneMarie Uliasz
New York, New York, United States, 10029
United States, North Carolina
Dr. Willard Niemi
Raleigh, North Carolina, United States, 27615
United States, Oregon
Dr. Diane Baker
Lake Oswego, Oregon, United States, 97035
Dr. John Barnes
Portland, Oregon, United States, 97205
United States, Pennsylvania
Dr. Harry Penny
Altoona, Pennsylvania, United States, 16602
Dr. Lawrence Parish
Philadelphia, Pennsylvania, United States, 19103
United States, South Carolina
Dr. Cynthia Strout
Mt. Pleasant, South Carolina, United States, 29464
United States, Texas
Dr. Teresa Coats
Austin, Texas, United States, 78705
Dr. Scott J. Ashton
Dallas, Texas, United States, 75243
Dr. Amit Pandya
Dallas, Texas, United States, 75390-8802
Dr. Lawrence Harkless
San Antonio, Texas, United States, 78207
United States, Virginia
Dr. Robert Shouey
Harrisonburg, Virginia, United States, 22801
Canada
Novartis Investigative Site
Various cities, Canada
Iceland
Novartis Investigative Site
Various cities, Iceland
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00443898     History of Changes
Other Study ID Numbers: CSFO327N2301
First Submitted: March 5, 2007
First Posted: March 7, 2007
Results First Submitted: January 19, 2011
Results First Posted: April 20, 2011
Last Update Posted: May 3, 2012
Last Verified: May 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Toenail fungus
Onychomycosis
Nail fungus
Toenail fungal infection
Tinea unguium
Dermatophytes
Foot dermatoses

Additional relevant MeSH terms:
Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases
Pharmaceutical Solutions
Terbinafine
Antifungal Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action