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: NCT00443898
• Other study ID #: CSFO327N2301
• Status: Completed
• Phase: Phase 3
• First received: March 5, 2007
• Last updated: May 1, 2012
• Start date: December 2006

Study information

• Verified date: May 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaIceland: Ministry of Health and Social Security
• 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: 518
• 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 terbinifine 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
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 48 weeks
• Placebo
vehicle (placebo) applied once daily for 48 weeks
• terbinafine
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 24 weeks
• Placebo
vehicle (placebo) applied once daily for 24 weeks

Locations

Country	Name	City	State
Canada	Novartis Investigative Site	Various cities
Iceland	Novartis Investigative Site	Various cities
United States	Dr. Harry Penny	Altoona	Pennsylvania
United States	Dr. Teresa Coats	Austin	Texas
United States	Dr. Boni Elewski	Birmingham	Alabama
United States	Dr. John Fenyk	Chaska	Minnesota
United States	Dr. Amit Pandya	Dallas	Texas
United States	Dr. Scott J. Ashton	Dallas	Texas
United States	Dr. James Swinehart	Denver	Colorado
United States	Dr. Robert Shouey	Harrisonburg	Virginia
United States	Dr. Diane Baker	Lake Oswego	Oregon
United States	Dr. Kevin Terry	Lutherville	Maryland
United States	Dr. Anthony Puopolo	Milford	Massachusetts
United States	Dr. Cynthia Strout	Mt. Pleasant	South Carolina
United States	Dr. AnneMarie Uliasz	New York	New York
United States	Dr. David G. Armstrong	North Chicago	Illinois
United States	Dr. Joel Schlessinger	Omaha	Nebraska
United States	Dr. Lawrence Parish	Philadelphia	Pennsylvania
United States	Dr. John Barnes	Portland	Oregon
United States	Dr. Willard Niemi	Raleigh	North Carolina
United States	Dr. Lawrence Harkless	San Antonio	Texas
United States	Dr. Stacy Smith	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  Iceland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy Assessed by Complete Cure Rate 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. The complete cure was a composite binary variable defined as "Yes" if: Mycological cure (negative KOH and negative culture for dermatophytes) and; No residual involvement of the target toenail "No" if otherwise	52 weeks	No
Secondary	Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 24 or 48 Weeks.	Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes.; Mycological cure was a composite binary variable defined as "Yes"if : Negative microscopy and; Negative culture for dermatophytes "No" if otherwise.	52 weeks	No
Secondary	Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients 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; Mycological cure (negative KOH and negative culture for dermatophytes) and; = 10% residual involvement of the target toenail "No" if otherwise	52 weeks	No
Secondary	Number of Participants Assessed With Adverse Events and Serious Adverse Events	An adverse event (AE) is any adverse change in health or side effect that occurs while the participant is receiving the treatment or within a previously specified period of time after the treatment has been completed.; A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening requires, inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage.	52 weeks	Yes