Spots Global Cancer Trial Database for A Study to Evaluate the Safety and Efficacy Imiquimod Cream, 2.5% in Participants With Actinic Keratoses
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Trial Identification
Brief Title: A Study to Evaluate the Safety and Efficacy Imiquimod Cream, 2.5% in Participants 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, 2.5% and Zyclara® (Imiquimod) Cream, 2.5% in Subjects With Actinic Keratoses
Study ID: NCT02120898
Conditions
Study Description
Brief Summary: The purpose of this study it so compare the safety and efficacy profiles of a generic imiquimod 2.5% cream to the reference listed Zyclara® (imiquimod) cream in the treatment of actinic keratosis (AK).
Detailed Description: Aldara® (imiquimod) Cream, 5% was the first imiquimod product approved by the Food and Drug Administration (FDA) for the topical treatment of AK, superficial basal cell carcinoma and external genital and perianal warts. The FDA approved regimen for the treatment of AK is application of 250 milligrams (mg) of cream twice a week for 16 weeks to a 25 square centimeters (cm\^2) area. In 2011, a lower strength imiquimod cream, Zyclara (imiquimod) Cream, 2.5% was approved by the FDA. When used for the treatment of AK, Zyclara is applied for a shorter duration and in an expanded treatment area (for example, face or scalp) in comparison to Aldara®. This study will be conducted in compliance with the protocol, Good Clinical Practice (GCP) and the applicable regulatory requirement(s). Marketed by Medicis, Zyclara® (imiquimod) cream 2.5% is a safe and effective topical therapy for the treatment of AK of the face and scalp. Actavis has developed a generic formulation of imiquimod 2.5% cream and the current study is designed to evaluate the safety and efficacy of this formulation.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Site 1, Birmingham, Alabama, United States
Site 10, Fremont, California, United States
Site 8, Los Angeles, California, United States
Site 24, Denver, Colorado, United States
Site 28, Boca Raton, Florida, United States
Site 26, Brandon, Florida, United States
Site 27, Brandon, Florida, United States
Site 21, Boise, Idaho, United States
Site 3, Arlington Heights, Illinois, United States
Site 17, Champaign, Illinois, United States
Site 7, Carmel, Indiana, United States
Site 15, Indianapolis, Indiana, United States
Site 22, Plainfield, Indiana, United States
Site 23, South Bend, Indiana, United States
Site 16, Clinton Township, Michigan, United States
Site 13, Fridley, Minnesota, United States
Site 9, Albuquerque, New Mexico, United States
Site 4, High Point, North Carolina, United States
Site 11, Wilmington, North Carolina, United States
Site 18, Winston-Salem, North Carolina, United States
Site 25, Portland, Oregon, United States
Site 20, Fountain Inn, South Carolina, United States
Site 6, Knoxville, Tennessee, United States
Site 5, Nashville, Tennessee, United States
Site 14, Austin, Texas, United States
Site 12, College Station, Texas, United States
Site 2, Houston, Texas, United States
Contact Details
Name: Study Director
Affiliation: Actavis Inc.
Role: STUDY_DIRECTOR
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