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

PHASE3CompletedINTERVENTIONAL
Enrollment

518

Participants

Timeline

Start Date

December 31, 2006

Primary Completion Date

June 30, 2008

Conditions
Onychomycosis
Interventions
DRUG

terbinafine

Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 48 weeks

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

DRUG

Placebo

vehicle (placebo) applied once daily for 24 weeks

Trial Locations (22)

10029

Dr. AnneMarie Uliasz, New York

16602

Dr. Harry Penny, Altoona

19103

Dr. Lawrence Parish, Philadelphia

21093

Dr. Kevin Terry, Lutherville

22801

Dr. Robert Shouey, Harrisonburg

27615

Dr. Willard Niemi, Raleigh

29464

Dr. Cynthia Strout, Mt. Pleasant

35233

Dr. Boni Elewski, Birmingham

55318

Dr. John Fenyk, Chaska

60064

Dr. David G. Armstrong, North Chicago

68144

Dr. Joel Schlessinger, Omaha

75243

Dr. Scott J. Ashton, Dallas

78207

Dr. Lawrence Harkless, San Antonio

78705

Dr. Teresa Coats, Austin

80210

Dr. James Swinehart, Denver

92123

Dr. Stacy Smith, San Diego

97035

Dr. Diane Baker, Lake Oswego

97205

Dr. John Barnes, Portland

01757

Dr. Anthony Puopolo, Milford

75390-8802

Dr. Amit Pandya, Dallas

Unknown

Novartis Investigative Site, Various Cities

Novartis Investigative Site, Various Cities

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY