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

PHASE3CompletedINTERVENTIONAL
Enrollment

526

Participants

Timeline

Start Date

December 31, 2006

Primary Completion Date

June 30, 2008

Study Completion Date

June 30, 2008

Conditions
Onychomycosis
Interventions
DRUG

terbinafine

Terbinafine hydrochloride (HCl) 10 % nail solution for onychomycosis (NSO) once daily for 48 weeks

DRUG

Placebo

Vehicle (placebo) once daily for 48 weeks

DRUG

terbinafine

Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis once daily for 24 weeks

DRUG

Placebo

Vehicle (placebo) once daily for 24 weeks

Trial Locations (23)

10032

Dr. Richard Scher, New York

21214

Dr. Max Weisfeld, Baltimore

23464

Dr. Patrick Agnew, Virginia Beach

27157

Dr. Joseph Jorrizo, Winston-Salem

29681

Dr. Patricia Westmorland, Simpsonville

30263

Dr. Mark Ling, Newnan

32935

Dr. Robert P. Dunne, Melbourne

37203

Dr. David Horowitz, Nashville

45230

Dr. Anne Lucky, Cincinnati

48202

Dr. Linda Stein-Gold, Detroit

60632

Dr. Jesse Plasencia, Chicago

63104

Dr. Anna Glaser, St Louis

66215

Dr. John Mallory, Overland Park

66606

Dr. Jeffrey Conrow, Topeka

70433

Dr.Michael Kaye, Covington

75061

Dr. Jay Lifshen, Irving

78229

Dr. Richard Pollak, San Antonio

80234

Dr. Larry Doehring, Northglenn

94945

Dr. Fred D. Youngswick, Novato

97210

Dr. Rich Phoebe, Portland

Unknown

Novartis Investigative Site, Various Cities

Novartis, Investigative Site

Novartis Investigative Site, Various Cities

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY