Bioequivalence of Generic Imiquimod Cream, 5% When Compared to Aldara™ (Imiquimod) Cream, 5% in the Treatment of Actinic Keratosis

PHASE3CompletedINTERVENTIONAL
Enrollment

462

Participants

Timeline

Start Date

May 31, 2008

Primary Completion Date

March 31, 2009

Study Completion Date

April 30, 2009

Conditions
Actinic Keratoses
Interventions
DRUG

imiquimod

5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks

DRUG

Aldara™

5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks

DRUG

Vehicle Cream

Topical cream vehicle matching Generic imiquimod dispensed in individual 0.25 g sachets applied twice a week for 16 weeks

Trial Locations (20)

10029

Mt. Sinai School of Medicine, New York

11790

Derm Research Center of New York, Inc., Stony Brook

30263

MedaPhase, Inc., Newnan

33175

FXM Research Corp., Miami

37215

Tennessee Clinical Research Center, Nashville

37917

Dermatology Associates of Knoxville, P.C., Knoxville

45219

University Dermatology Consultants, Inc., Cincinnati

47713

Deaconess Clinic, Inc., Evansville

55432

Minnesota Clinical Study Center, Fridley

71913

Burke Pharmaceutical Research, Hot Springs

77056

Suzanne Bruce & Associates, P.A., Houston

78229

Dermatology Clinical Research Center of San Antonio, San Antonio

78759

DermResearch, Inc., Austin

80209

Cherry Creek Research, Inc., Denver

84124

Dermatology Research Center, Inc., Salt Lake City

92117

Skin Surgery Medical Group, Inc., San Diego

93720

Associates in Research, Inc., Fresno

97223

Oregon Medical Research Center, P.C., Portland

99204

Premier Clinical Research, Spokane

02903

Rhode Island Hospital, Dermatopharmacology Division, Providence

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Actavis Inc.

INDUSTRY

NCT00948428 - Bioequivalence of Generic Imiquimod Cream, 5% When Compared to Aldara™ (Imiquimod) Cream, 5% in the Treatment of Actinic Keratosis | Biotech Hunter | Biotech Hunter