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
526
3 countries
23
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
Started Dec 2006
23 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 2, 2007
CompletedFirst Posted
Study publicly available on registry
March 6, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedResults Posted
Study results publicly available
April 19, 2011
CompletedApril 19, 2011
March 1, 2011
1.5 years
March 2, 2007
January 19, 2011
March 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy Assessed by the Percentage of Participants With Complete Cure 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.
52 weeks
Secondary Outcomes (3)
Efficacy Assessed by the Percentage of Participants With Mycological Cure at the End of Study After Treating Participants for 24 or 48 Weeks
52 weeks
Efficacy Assessed by the Percentage of Participants With Clinical Effectiveness at the End of Study After Treating Participants for 24 or 48 Weeks
52 weeks
Safety and Tolerability Assessed by the Number of Participants With Adverse Events
52 weeks
Study Arms (4)
1
EXPERIMENTALTerbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
2
PLACEBO COMPARATORVehicle (placebo) for 48 weeks
3
EXPERIMENTALTerbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
4
PLACEBO COMPARATORVehicle (placebo) for 24 weeks
Interventions
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 terbinafine 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 (23)
Dr. Fred D. Youngswick
Novato, California, 94945, United States
Dr. Larry Doehring
Northglenn, Colorado, 80234, United States
Dr. Robert P. Dunne
Melbourne, Florida, 32935, United States
Dr. Mark Ling
Newnan, Georgia, 30263, United States
Dr. Jesse Plasencia
Chicago, Illinois, 60632, United States
Dr. John Mallory
Overland Park, Kansas, 66215, United States
Dr. Jeffrey Conrow
Topeka, Kansas, 66606, United States
Dr.Michael Kaye
Covington, Louisiana, 70433, United States
Dr. Max Weisfeld
Baltimore, Maryland, 21214, United States
Dr. Linda Stein-Gold
Detroit, Michigan, 48202, United States
Dr. Anna Glaser
St Louis, Missouri, 63104, United States
Dr. Richard Scher
New York, New York, 10032, United States
Dr. Joseph Jorrizo
Winston-Salem, North Carolina, 27157, United States
Dr. Anne Lucky
Cincinnati, Ohio, 45230, United States
Dr. Rich Phoebe
Portland, Oregon, 97210, United States
Dr. Patricia Westmorland
Simpsonville, South Carolina, 29681, United States
Dr. David Horowitz
Nashville, Tennessee, 37203, United States
Dr. Jay Lifshen
Irving, Texas, 75061, United States
Dr. Richard Pollak
San Antonio, Texas, 78229, United States
Dr. Patrick Agnew
Virginia Beach, Virginia, 23464, United States
Novartis Investigative Site
Various Cities, France
Novartis
Investigative Site, Germany
Novartis Investigative Site
Various Cities, Germany
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
Study Record Dates
First Submitted
March 2, 2007
First Posted
March 6, 2007
Study Start
December 1, 2006
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
April 19, 2011
Results First Posted
April 19, 2011
Record last verified: 2011-03