Clinical trial NCT00443898: Efficacy, Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Onychomycosis
Keywords: Toenail fungus
Onychomycosis
Nail fungus
Toenail fungal infection
Tinea unguium
Dermatophytes
Foot dermatoses
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-03-07
Enrollment: 518
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 24 or 48 Weeks.
timeFrame: 52 weeks
Secondary outcomes:
measure: Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 24 or 48 Weeks.
timeFrame: 52 weeks
measure: Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients for 24 or 48 Weeks.
timeFrame: 52 weeks
measure: Number of Participants Assessed With Adverse Events and Serious Adverse Events
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Dr. Boni Elewski
state: Alabama
city: San Diego
country: United States
facility: Dr. Stacy Smith
state: California
city: Denver
country: United States
facility: Dr. James Swinehart
state: Colorado
city: North Chicago
country: United States
facility: Dr. David G. Armstrong
state: Illinois
city: Lutherville
country: United States
facility: Dr. Kevin Terry
state: Maryland
city: Milford
country: United States
facility: Dr. Anthony Puopolo
state: Massachusetts
city: Chaska
country: United States
facility: Dr. John Fenyk
state: Minnesota
city: Omaha
country: United States
facility: Dr. Joel Schlessinger
state: Nebraska
city: New York
country: United States
facility: Dr. AnneMarie Uliasz
state: New York
city: Raleigh
country: United States
facility: Dr. Willard Niemi
state: North Carolina
city: Lake Oswego
country: United States
facility: Dr. Diane Baker
state: Oregon
city: Portland
country: United States
facility: Dr. John Barnes
state: Oregon
city: Altoona
country: United States
facility: Dr. Harry Penny
state: Pennsylvania
city: Philadelphia
country: United States
facility: Dr. Lawrence Parish
state: Pennsylvania
city: Mt. Pleasant
country: United States
facility: Dr. Cynthia Strout
state: South Carolina
city: Austin
country: United States
facility: Dr. Teresa Coats
state: Texas
city: Dallas
country: United States
facility: Dr. Scott J. Ashton
state: Texas
city: Dallas
country: United States
facility: Dr. Amit Pandya
state: Texas
city: San Antonio
country: United States
facility: Dr. Lawrence Harkless
state: Texas
city: Harrisonburg
country: United States
facility: Dr. Robert Shouey
state: Virginia
city: Various cities
country: Canada
facility: Novartis Investigative Site
city: Various cities
country: Iceland
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: