Spots Global Cancer Trial Database for A Bioequivalence Study With Clinical Endpoints Comparing Generic Imiquimod Cream, 3.75% and Zyclara™ (Imiquimod) Cream, 3.75% in Subjects With Actinic Keratoses
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Trial Identification
Brief Title: A Bioequivalence Study With Clinical Endpoints Comparing Generic Imiquimod Cream, 3.75% and Zyclara™ (Imiquimod) Cream, 3.75% in Subjects With Actinic Keratoses
Official Title: 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
Study ID: NCT01502020
Conditions
Study Description
Brief Summary: Zyclara™ (imiquimod) Cream, 3.75% is approved by the FDA for the treatment of actinic keratoses on the full face or balding scalp. Zyclara is applied once daily for two, 2-week treatment cycles separated by a 2-week no treatment applied interval. A generic imiquimod cream, 3.75% has been developed by Actavis Mid-Atlantic LLC for the topical treatment of clinically typical, visible or palpable actinic keratoses (AK) of the full face or balding scalp. The current clinical study is designed to evaluate the therapeutic equivalence of this formulation with the currently marketed Zyclara™ (imiquimod) cream, 3.75% formulation (Graceway Pharmaceuticals LLC).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Total Skin and Beauty Dermatology Center, PC, Birmingham, Alabama, United States
International Dermatology Research, Inc., Miami, Florida, United States
MedaPhase, Inc., Newnan, Georgia, United States
Northwest Clinical Trials, Boise, Idaho, United States
Altman Dermatology Associates, Arlington Heights, Illinois, United States
Deaconess Clinic, Inc., Evansville, Indiana, United States
Indiana Clinical Trials Center, Plainfield, Indiana, United States
Dermatology Specialists, Louisville, Kentucky, United States
Michigan Center for Research Corp., Clinton Township, Michigan, United States
Minnesota Clinical Study Center, Fridley, Minnesota, United States
Skin Specialists, P.C., Omaha, Nebraska, United States
Academic Dermatology Associates, Albuquerque, New Mexico, United States
Dermatology, Laser & Vein Specialists of the Carolinas,, Charlotte, North Carolina, United States
Dermatology Research Center of Cincinnati, Cincinnati, Ohio, United States
Oregon Medical Research Center, PC, Portland, Oregon, United States
Philadelphia Institute of Dermatology, Fort Washington, Pennsylvania, United States
DermResearch, Inc., Austin, Texas, United States
Suzanne Bruce and Associates, P.A., Houston, Texas, United States
Dermatology Clinical Research Center of San Antonio, San Antonio, Texas, United States
Contact Details
Name: Daniel Piacquadio, M.D.
Affiliation: Therapeutics, Inc.
Role: STUDY_DIRECTOR
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