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

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00443898

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 III

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

MedlinePlus related topics: Fungal Infections Molds

Drug Information available for: Terbinafine hydrochloride Terbinafine

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome 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. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Efficacy assessed by mycological cure (negative culture and negative KOH microscopy) and clinical efficacy (less than or equal to 10% residual disease involvement) at the end of study after treating patients for 24 or 48 weeks. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Safety assessed by adverse events, serious adverse events, hematology and chemistry. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	518
Study Start Date:	December 2006
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks	Drug: terbinafine Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 48 weeks
2: Placebo Comparator vehicle (placebo) for 48 weeks	Drug: Placebo vehicle (placebo) once daily for 48 weeks
3: Experimental Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks	Drug: terbinafine Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 24 weeks
4: Placebo Comparator vehicle (placebo) for 24 weeks	Drug: Placebo vehicle (placebo) 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

More Information

Additional Information:

Click here to get more information on this study. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CSFO327N2301
Study First Received:	March 5, 2007
Last Updated:	August 3, 2009
ClinicalTrials.gov Identifier:	NCT00443898 History of Changes
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:

Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Enzyme Inhibitors
Infection
Pharmacologic Actions
Mycoses
Skin Diseases, Infectious

Onychomycosis
Nail Diseases
Antifungal Agents
Therapeutic Uses
Tinea
Dermatomycoses
Terbinafine

ClinicalTrials.gov processed this record on February 08, 2010