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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2008

Intervention(s) in this Clinical Trial

• Drug: terbinafine
  • Active terbinafine hydrochloride (HCl) Nail Solution for Onychomycosis (NSO) once daily for 48 weeks
• Drug: Placebo
  • vehicle (placebo) once daily for 48 weeks
• Drug: terbinafine
  • Active terbinafine hydrochloride (HCl) Nail Solution for Onychomycosis (NSO) once daily for 24 weeks
• Drug: Placebo
  • vehicle (placebo) once daily for 24 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Active terbinafine hydrochloride (HCl) Nail Solution for Onychomycosis (NSO) for 48 weeks
• Placebo Comparator: 2
  • vehicle (placebo) for 48 weeks
• Experimental: 3
  • Active terbinafine hydrochloride (HCl) Nail Solution for Onychomycosis (NSO) for 24 weeks
• Placebo Comparator: 4
  • vehicle (placebo) for 24 weeks

Primary Measures

• 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 Measures

• 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.

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals, One Health Plaza, East Hanover, NJ 07936-1080, Tel.: 862-778-8300  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00443898

Study ID Number: CSFO327N2301

ClinicalTrials.gov Identifier: NCT00443898

Health Authority: United States: Food and Drug Administration

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