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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00443898
First received: March 5, 2007
Last updated: May 1, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Onychomycosis
 Drug: terbinafine
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 24 or 48 Weeks. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

    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


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 518
Study Start Date: December 2006
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
 Drug: terbinafine
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 48 weeks
Other Name: Lamisil
Placebo Comparator: 2
vehicle (placebo) applied once daily for 48 weeks
 Drug: Placebo
vehicle (placebo) applied once daily for 48 weeks
Experimental: 3
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
 Drug: terbinafine
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 24 weeks
Other Name: Lamisil
Placebo Comparator: 4
vehicle (placebo) applied once daily for 24 weeks
 Drug: Placebo
vehicle (placebo) applied once daily for 24 weeks

  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00443898

  Show 22 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00443898     History of Changes
Other Study ID Numbers: CSFO327N2301
Study First Received: March 5, 2007
Results First Received: January 19, 2011
Last Updated: May 1, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Iceland: Ministry of Health and Social Security

Keywords provided by Novartis:
Toenail fungus
Onychomycosis
Nail fungus
Toenail fungal infection
 Tinea unguium
Dermatophytes
Foot dermatoses

Additional relevant MeSH terms:
Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases
 Terbinafine
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013