Efficacy Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Onychomycosis
Intervention: terbinafine (Drug); Placebo (Drug); terbinafine (Drug); Placebo (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals Novartis Pharmaceuticals, Affiliation: Novartis
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Efficacy assessed by complete cure rate (negative culture, negative KOH microscopy and no residual disease involvement)at the end of study (week 52) after treating for 24 or 48 weeks.
Secondary outcome: Efficacy assessed by mycological cure (negative culture and negative KOH microscopy) and clinical efficacy (less than 10% residual disease involvement) at the end of study after treating patients for 24 or 48 weeks.Safety assessed by adverse events.
Eligibility
Minimum age: 12 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Novartis Investigative Site, Various Cities, France
Novartis Investigative Site, Various cities, Germany
Novartis, Investigative Site, Germany
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. Jeffrey Conrow, Topeka, Kansas 66606, United States
Dr. John Mallory, Overland Park, Kansas 66215, 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. Richard Pollak, San Antonio, Texas 78229, United States
Dr. Jay Lifshen, Irving,, Texas 75061, United States
Dr. Patrick Agnew, Virginia Beach, Virginia 23464, United States
Additional Information
Click here to get more information on this study.
Starting date: December 2006
Ending date: July 2008
Last updated: February 15, 2008
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