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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00443820
• Other study ID #: CSFO327N2302
• Status: Completed
• Phase: Phase 3
• First received: March 2, 2007
• Last updated: March 22, 2011
• Start date: December 2006
• Est. completion date: June 2008

Study information

• Verified date: March 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Onychomycosis

Intervention

Drug:
• terbinafine
Terbinafine hydrochloride (HCl) 10 % nail solution for onychomycosis (NSO) once daily for 48 weeks
• Placebo
Vehicle (placebo) once daily for 48 weeks
• terbinafine
Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis once daily for 24 weeks
• Placebo
Vehicle (placebo) once daily for 24 weeks

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  France,  Germany, 

Outcome

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