Clinical trial NCT00443820: 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: 2007-03-06
Enrollment: 526
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 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

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Efficacy Assessed by the Percentage of Participants With Complete Cure at the End of Study (Week 52) After Treating for 24 or 48 Weeks
timeFrame: 52 weeks
Secondary outcomes:
measure: Efficacy Assessed by the Percentage of Participants With Mycological Cure at the End of Study After Treating Participants for 24 or 48 Weeks
timeFrame: 52 weeks
measure: Efficacy Assessed by the Percentage of Participants With Clinical Effectiveness at the End of Study After Treating Participants for 24 or 48 Weeks
timeFrame: 52 weeks
measure: Safety and Tolerability Assessed by the Number of Participants With Adverse Events
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Novato
country: United States
facility: Dr. Fred D. Youngswick
state: California
city: Northglenn
country: United States
facility: Dr. Larry Doehring
state: Colorado
city: Melbourne
country: United States
facility: Dr. Robert P. Dunne
state: Florida
city: Newnan
country: United States
facility: Dr. Mark Ling
state: Georgia
city: Chicago
country: United States
facility: Dr. Jesse Plasencia
state: Illinois
city: Overland Park
country: United States
facility: Dr. John Mallory
state: Kansas
city: Topeka
country: United States
facility: Dr. Jeffrey Conrow
state: Kansas
city: Covington
country: United States
facility: Dr.Michael Kaye
state: Louisiana
city: Baltimore
country: United States
facility: Dr. Max Weisfeld
state: Maryland
city: Detroit
country: United States
facility: Dr. Linda Stein-Gold
state: Michigan
city: St. Louis
country: United States
facility: Dr. Anna Glaser
state: Missouri
city: New York
country: United States
facility: Dr. Richard Scher
state: New York
city: Winston Salem
country: United States
facility: Dr. Joseph Jorrizo
state: North Carolina
city: Cincinnati
country: United States
facility: Dr. Anne Lucky
state: Ohio
city: Portland
country: United States
facility: Dr. Rich Phoebe
state: Oregon
city: Simpsonville
country: United States
facility: Dr. Patricia Westmorland
state: South Carolina
city: Nashville
country: United States
facility: Dr. David Horowitz
state: Tennessee
city: Irving,
country: United States
facility: Dr. Jay Lifshen
state: Texas
city: San Antonio
country: United States
facility: Dr. Richard Pollak
state: Texas
city: Virginia Beach
country: United States
facility: Dr. Patrick Agnew
state: Virginia
city: Various Cities
country: France
facility: Novartis Investigative Site
city: Investigative Site
country: Germany
facility: Novartis
city: Various cities
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: