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

Completed · Phase 3 · Has a placebo group

Conditions studied: Onychomycosis

In brief

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.

Key facts

Study ID

NCT00443820

Run by

Novartis Pharmaceuticals

People needed

526

Starts

2006-12-01

Expected to finish

2008-06-01

Last updated by the study team

2011-04-19

Who can join

Age: 12 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Dr. Fred D. Youngswick — Novato, California, United States
• Dr. Larry Doehring — Northglenn, Colorado, United States
• Dr. Robert P. Dunne — Melbourne, Florida, United States
• Dr. Mark Ling — Newnan, Georgia, United States
• Dr. Jesse Plasencia — Chicago, Illinois, United States
• Dr. John Mallory — Overland Park, Kansas, United States
• Dr. Jeffrey Conrow — Topeka, Kansas, United States
• Dr.Michael Kaye — Covington, Louisiana, United States
• Dr. Max Weisfeld — Baltimore, Maryland, United States
• Dr. Linda Stein-Gold — Detroit, Michigan, United States
• Dr. Anna Glaser — St Louis, Missouri, United States
• Dr. Richard Scher — New York, New York, United States
• Dr. Joseph Jorrizo — Winston-Salem, North Carolina, United States
• Dr. Anne Lucky — Cincinnati, Ohio, United States
• Dr. Rich Phoebe — Portland, Oregon, United States
• Dr. Patricia Westmorland — Simpsonville, South Carolina, United States
• Dr. David Horowitz — Nashville, Tennessee, United States
• Dr. Jay Lifshen — Irving, Texas, United States
• Dr. Richard Pollak — San Antonio, Texas, United States
• Dr. Patrick Agnew — Virginia Beach, Virginia, United States
• Novartis Investigative Site — Various Cities, France
• Novartis — Investigative Site, Germany
• Novartis Investigative Site — Various Cities, Germany

Full record on ClinicalTrials.gov

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