Efficacy, Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail
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
1 other identifier
interventional
518
3 countries
22
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
22 active sites
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
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 5, 2007
CompletedFirst Posted
Study publicly available on registry
March 7, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedResults Posted
Study results publicly available
April 20, 2011
CompletedMay 3, 2012
May 1, 2012
1.5 years
March 5, 2007
January 19, 2011
May 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 24 or 48 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
52 weeks
Secondary Outcomes (3)
Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 24 or 48 Weeks.
52 weeks
Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients for 24 or 48 Weeks.
52 weeks
Number of Participants Assessed With Adverse Events and Serious Adverse Events
52 weeks
Study Arms (4)
1
EXPERIMENTALActive terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
2
PLACEBO COMPARATORvehicle (placebo) applied once daily for 48 weeks
3
EXPERIMENTALActive terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
4
PLACEBO COMPARATORvehicle (placebo) applied once daily for 24 weeks
Interventions
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 48 weeks
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Dr. Boni Elewski
Birmingham, Alabama, 35233, United States
Dr. Stacy Smith
San Diego, California, 92123, United States
Dr. James Swinehart
Denver, Colorado, 80210, United States
Dr. David G. Armstrong
North Chicago, Illinois, 60064, United States
Dr. Kevin Terry
Lutherville, Maryland, 21093, United States
Dr. Anthony Puopolo
Milford, Massachusetts, 01757, United States
Dr. John Fenyk
Chaska, Minnesota, 55318, United States
Dr. Joel Schlessinger
Omaha, Nebraska, 68144, United States
Dr. AnneMarie Uliasz
New York, New York, 10029, United States
Dr. Willard Niemi
Raleigh, North Carolina, 27615, United States
Dr. Diane Baker
Lake Oswego, Oregon, 97035, United States
Dr. John Barnes
Portland, Oregon, 97205, United States
Dr. Harry Penny
Altoona, Pennsylvania, 16602, United States
Dr. Lawrence Parish
Philadelphia, Pennsylvania, 19103, United States
Dr. Cynthia Strout
Mt. Pleasant, South Carolina, 29464, United States
Dr. Teresa Coats
Austin, Texas, 78705, United States
Dr. Scott J. Ashton
Dallas, Texas, 75243, United States
Dr. Amit Pandya
Dallas, Texas, 75390-8802, United States
Dr. Lawrence Harkless
San Antonio, Texas, 78207, United States
Dr. Robert Shouey
Harrisonburg, Virginia, 22801, United States
Novartis Investigative Site
Various Cities, Canada
Novartis Investigative Site
Various Cities, Iceland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2007
First Posted
March 7, 2007
Study Start
December 1, 2006
Primary Completion
June 1, 2008
Last Updated
May 3, 2012
Results First Posted
April 20, 2011
Record last verified: 2012-05