Efficacy and Safety Study of 4 Dose Regimens of Oral Albaconazole in Subjects With Distal Subungual Onychomycosis

PHASE2CompletedINTERVENTIONAL
Enrollment

582

Participants

Timeline

Start Date

July 16, 2008

Primary Completion Date

February 19, 2010

Study Completion Date

February 19, 2010

Conditions
Onychomycosis
Interventions
DRUG

Albaconazole 100mg

Albaconazole for 36 weeks

DRUG

Albaconazole 200mg

Albaconazole for 36 weeks

DRUG

Albaconazole 400mg

Albaconazole for 36 weeks

DRUG

Albaconazole 400mg

Albaconazole for 24 weeks, Placebo for 12 weeks

DRUG

Placebo 400 mg

Placebo for 36 weeks

Trial Locations (33)

201

Dermatology Centre, University of Iceland, Hudlaeknaslodin

10016

NYU Medical Center, New York

24501

Education and Research Foundation, Lynchburg

27599

University of North Carolina at Chapel Hill, Chapel Hill

30078

Gwinnett Clinical Research Center, Inc., Snellville

30263

MedaPhase, Inc, Newnan

33140

Greater Miami Skin & Laser Center, Miami Beach

33144

International Dermatology Research Inc, Miami

33169

Miami Dermatology Research Institute LLC, North Miami Beach

35233

University of Alabama at Birmingham, Birmingham

37215

Tennessee Clinical Research, Nashville

37922

The Skin Wellness Center, Knoxville

47713

Welborn Clinic, Evansville

48202

Henry Ford Medical Center, Detroit

55432

Minnesota Clinical Study Center, Fridley

68144

Skin Specialists, Inc, Omaha

75234

Research Across America, Dallas

77058

Center for Clinical Studies, Houston

77845

J & S Studies, Inc., College Station

78759

DermResearch, Inc., Austin

80915

Thomas J. Stephens & Associates, Inc. Colorado Research Center, Colorado Springs

84124

DermatologyResearch Center, Salt Lake City

85791

Genova Clinical Research, Tucson

90211

Impact Clinical Trials, Beverly Hills

92123

Therapeutics Clinical Research, San Diego

94115

UCSF Dermatology Research, San Francisco

94538

Center for Dermatology Clinical Research, Fremont

95608

Northern California Research, Carmichael

97210

Oregon Dermatology & Research Centre, Portland

97223

Oregon Medical, Portland

L4M 6L2

Ultranova Skincare, Barrie

P1B 3Z7

North Bay Dermatology Centre Inc., North Bay

N2J 1C4

K. Papp Clinical Research Inc., Waterloo

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Stiefel, a GSK Company

INDUSTRY

NCT00730405 - Efficacy and Safety Study of 4 Dose Regimens of Oral Albaconazole in Subjects With Distal Subungual Onychomycosis | Biotech Hunter | Biotech Hunter