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

Phase 3

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
1	terbinafine	Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
2	Placebo	Vehicle (placebo) for 48 weeks
3	terbinafine	Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
4	Placebo	Vehicle (placebo) for 24 weeks

Primary Outcome Measures

Name	Time	Method
Efficacy Assessed by the Percentage of Participants With Complete Cure at the End of Study (Week 52) After Treating for 24 or 48 Weeks	52 weeks	Complete cure is defined as negative KOH microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.

Secondary Outcome Measures

Name	Time	Method
Efficacy Assessed by the Percentage of Participants With Mycological Cure at the End of Study After Treating Participants for 24 or 48 Weeks	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	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	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.

Locations (22): Dr. John Mallory
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Overland Park, Kansas, United States
Dr. Max Weisfeld
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Baltimore, Maryland, United States
Dr. Jeffrey Conrow
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Topeka, Kansas, United States
Dr. Patricia Westmorland
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Simpsonville, South Carolina, United States
Novartis Investigative Site
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Various cities, Germany
Dr.Michael Kaye
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Covington, Louisiana, United States
Dr. Robert P. Dunne
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Melbourne, Florida, United States
Dr. Rich Phoebe
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Portland, Oregon, United States
Dr. David Horowitz
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Nashville, Tennessee, United States
Dr. Richard Scher
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New York, New York, United States
Dr. Mark Ling
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Newnan, Georgia, United States
Dr. Patrick Agnew
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Virginia Beach, Virginia, United States
Dr. Jesse Plasencia
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Chicago, Illinois, United States
Dr. Joseph Jorrizo
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Winston Salem, North Carolina, United States
Dr. Anna Glaser
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St. Louis, Missouri, United States
Dr. Anne Lucky
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Cincinnati, Ohio, United States
Dr. Jay Lifshen
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Irving,, Texas, United States
Dr. Richard Pollak
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San Antonio, Texas, United States
Dr. Fred D. Youngswick
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Novato, California, United States
Dr. Larry Doehring
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Northglenn, Colorado, United States
Novartis
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Investigative Site, Germany
Dr. Linda Stein-Gold
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Detroit, Michigan, United States