Onychomycosis Clinical Trial
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
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.
Status | Completed |
Enrollment | 526 |
Est. completion date | June 2008 |
Est. primary completion date | June 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Novartis Investigative Site | Various Cities | |
Germany | Novartis | Investigative Site | |
Germany | Novartis Investigative Site | Various cities | |
United States | Dr. Max Weisfeld | Baltimore | Maryland |
United States | Dr. Jesse Plasencia | Chicago | Illinois |
United States | Dr. Anne Lucky | Cincinnati | Ohio |
United States | Dr.Michael Kaye | Covington | Louisiana |
United States | Dr. Linda Stein-Gold | Detroit | Michigan |
United States | Dr. Jay Lifshen | Irving, | Texas |
United States | Dr. Robert P. Dunne | Melbourne | Florida |
United States | Dr. David Horowitz | Nashville | Tennessee |
United States | Dr. Richard Scher | New York | New York |
United States | Dr. Mark Ling | Newnan | Georgia |
United States | Dr. Larry Doehring | Northglenn | Colorado |
United States | Dr. Fred D. Youngswick | Novato | California |
United States | Dr. John Mallory | Overland Park | Kansas |
United States | Dr. Rich Phoebe | Portland | Oregon |
United States | Dr. Richard Pollak | San Antonio | Texas |
United States | Dr. Patricia Westmorland | Simpsonville | South Carolina |
United States | Dr. Anna Glaser | St. Louis | Missouri |
United States | Dr. Jeffrey Conrow | Topeka | Kansas |
United States | Dr. Patrick Agnew | Virginia Beach | Virginia |
United States | Dr. Joseph Jorrizo | Winston Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States, France, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Efficacy Assessed by the Percentage of Participants With Mycological Cure at the End of Study After Treating Participants for 24 or 48 Weeks | Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes. | 52 weeks | No |
Secondary | Efficacy Assessed by the Percentage of Participants With Clinical Effectiveness at the End of Study After Treating Participants for 24 or 48 Weeks | Clinical effectiveness is defined as negative KOH microscopy and negative culture for dermatophytes and <= 10% residual involvement of the target toenail. Clinical effectiveness was a composite binary variable defined as "Yes" if: If mycological cure (negative KOH and negative culture for dermatophytes) and = 10% residual involvement of the target toenail "No" if otherwise |
52 weeks | No |
Secondary | Safety and Tolerability Assessed by the Number of Participants With Adverse Events | Safety and tolerability data as assessed by the number of participants with Adverse Events (AE), Serious Adverse Events, Drug discontinuation due to an AE and death. Additional details can be found in the Adverse Event Section. | 52 weeks | Yes |
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