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

• ClinicalTrials.gov Identifier: NCT00443820
• Recruitment Status: Completed
• First Posted: March 6, 2007
• Results First Posted: April 19, 2011
• Last Update Posted: April 19, 2011
• Sponsor: Novartis Pharmaceuticals
• Information provided by: Novartis

Tracking Information

• First Submitted Date: March 2, 2007
• First Posted Date: March 6, 2007
• Results First Submitted Date: January 19, 2011
• Results First Posted Date: April 19, 2011
• Last Update Posted Date: April 19, 2011
• Study Start Date: December 2006
• Actual Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 22, 2011)

Efficacy Assessed by the Percentage of Participants With Complete Cure at the End of Study (Week 52) After Treating for 24 or 48 Weeks [ Time Frame: 52 weeks ]

Complete cure is defined as negative KOH microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.

• Original Primary Outcome Measures (submitted: March 5, 2007): 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.

Current Secondary Outcome Measures (submitted: March 22, 2011)

• Efficacy Assessed by the Percentage of Participants With Mycological Cure at the End of Study After Treating Participants for 24 or 48 Weeks [ Time Frame: 52 weeks ]
  Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes.
• Efficacy Assessed by the Percentage of Participants With Clinical Effectiveness at the End of Study After Treating Participants for 24 or 48 Weeks [ Time Frame: 52 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
• Safety and Tolerability Assessed by the Number of Participants With Adverse Events [ Time Frame: 52 weeks ]
  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.

Original Secondary Outcome Measures (submitted: March 5, 2007)

• 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail
• 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
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Onychomycosis

Intervention

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

Study Arms

• Experimental: 1
  Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
  Intervention: Drug: terbinafine
• Placebo Comparator: 2
  Vehicle (placebo) for 48 weeks
  Intervention: Drug: Placebo
• Experimental: 3
  Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
  Intervention: Drug: terbinafine
• Placebo Comparator: 4
  Vehicle (placebo) for 24 weeks
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 30, 2009): 526
• Original Enrollment (submitted: March 5, 2007): 500
• Actual Study Completion Date: June 2008
• Actual Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years to 75 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France, Germany, United States

Administrative Information

• NCT Number: NCT00443820
• Other Study ID Numbers: CSFO327N2302
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: External Affairs, Novartis Pharmaceuticals
• Study Sponsor: Novartis Pharmaceuticals
• Collaborators: Not Provided

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

• PRS Account: Novartis
• Verification Date: March 2011