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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

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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