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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00443820
Other study ID # CSFO327N2302
Secondary ID
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


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
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