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

Tracking Information
First Submitted Date ICMJE	March 2, 2007
First Posted Date ICMJE	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 ICMJE	December 2006
Actual Primary Completion Date	June 2008 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (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 ICMJE; (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.
Change History	Complete list of historical versions of study NCT00443820 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (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 ICMJE; (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 Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Efficacy Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail
Official Title ICMJE	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 ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition ICMJE	Onychomycosis
Intervention ICMJE	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
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: March 30, 2009)	526
Original Enrollment ICMJE; (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 ICMJE	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, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	France, Germany, United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00443820
Other Study ID Numbers ICMJE	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 ICMJE	Novartis Pharmaceuticals
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account	Novartis
Verification Date	March 2011
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP