A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Comparison Study to Determine the Therapeutic Equivalence of Generic Imiquimod Cream, 3.75% and Zyclara™ (Imiquimod) Cream, 3.75% in Subjects With Actinic Keratoses
Interventional
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Complete clearance rate
Complete clearance rate (treatment success) was defined as the proportion of subjects in a treatment group with 100% clearance of all AK lesions within the Treatment Area. The primary efficacy endpoint was the proportion of subjects in the per-protocol (PP) population with treatment success at Week 14/EOS. All AKs (Baseline and new lesions), independent of size, within the Treatment Area were included in the AK lesion counts.
8 weeks post treatment period
No
Daniel Piacquadio, M.D.
Study Director
Therapeutics, Inc.
United States: Institutional Review Board
094-3152-301
NCT01502020
February 2011
November 2011
Name | Location |
---|---|
Minnesota Clinical Study Center | Fridley, Minnesota 55432 |
Academic Dermatology Associates | Albuquerque, New Mexico 87106 |
Dermatology Clinical Research Center of San Antonio | San Antonio, Texas 78229 |
DermResearch, Inc. | Austin, Texas 78759 |
Altman Dermatology Associates | Arlington Heights, Illinois 60004 |
Philadelphia Institute of Dermatology | Fort Washington, Pennsylvania 19034 |
Dermatology Specialists | Louisville, Kentucky 40202 |
Northwest Clinical Trials | Boise, Idaho 83704 |
Deaconess Clinic, Inc. | Evansville, Indiana 47713 |
International Dermatology Research, Inc. | Miami, Florida |
MedaPhase, Inc. | Newman, Georgia 30263 |
Oregon Medical Research Center, PC | Portland, Oregon 97223 |
Dermatology Research Center of Cincinnati | Cincinnati, Ohio 45220 |
Total Skin and Beauty Dermatology Center, PC | Birmingham, Alabama 35205 |
Indiana Clinical Trials Center | Plainfield, Indiana 46168 |
Michigan Center for Research Corp. | Clinton Township, Michigan 48038 |
Skin Specialists, P.C. | Omaha, Nebraska 68144 |
Dermatology, Laser & Vein Specialists of the Carolinas, | Charlotte, North Carolina 28207 |
Suzanne Bruce and Associates, P.A. | Houston, Texas 77056 |