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

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ClinicalTrials.gov Identifier: NCT00443898
Recruitment Status : Completed
First Posted : March 7, 2007
Results First Posted : April 20, 2011
Last Update Posted : May 3, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE March 5, 2007
First Posted Date  ICMJE March 7, 2007
Results First Submitted Date  ICMJE January 19, 2011
Results First Posted Date  ICMJE April 20, 2011
Last Update Posted Date May 3, 2012
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 23, 2011)
Efficacy Assessed by Complete Cure Rate 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. 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
Original Primary Outcome Measures  ICMJE
 (submitted: March 6, 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
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2011)
  • Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 24 or 48 Weeks. [ Time Frame: 52 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.
  • Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients 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
    • Mycological cure (negative KOH and negative culture for dermatophytes) and
    • = 10% residual involvement of the target toenail "No" if otherwise
  • Number of Participants Assessed With Adverse Events and Serious Adverse Events [ Time Frame: 52 weeks ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 6, 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  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  ICMJE 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
    Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 48 weeks
    Other Name: Lamisil
  • Drug: Placebo
    vehicle (placebo) applied once daily for 48 weeks
  • Drug: terbinafine
    Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 24 weeks
    Other Name: Lamisil
  • Drug: Placebo
    vehicle (placebo) applied once daily for 24 weeks
Study Arms  ICMJE
  • Experimental: 1
    Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
    Intervention: Drug: terbinafine
  • Placebo Comparator: 2
    vehicle (placebo) applied once daily for 48 weeks
    Intervention: Drug: Placebo
  • Experimental: 3
    Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
    Intervention: Drug: terbinafine
  • Placebo Comparator: 4
    vehicle (placebo) applied once daily 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)
518
Original Enrollment  ICMJE
 (submitted: March 6, 2007)
500
Study Completion Date  ICMJE Not Provided
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 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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Iceland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00443898
Other Study ID Numbers  ICMJE CSFO327N2301
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP