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Brief Title: Multicenter, Double-blind, Placebo Controlled Comparing Test Fluorouracil Cream to Carac Cream in Actinic Keratosis
Official Title: A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Comparison Study to Determine the Therapeutic Equivalence of Generic Fluorouracil Cream, 0.5% and Carac® (Fluorouracil) Cream, 0.5% in Subjects With Actinic Keratoses
Study ID: NCT02616601
Brief Summary: This study is to evaluate the efficacy and safety of a generic formulation of fluorouracil 0.5% cream against the brand product (Carac) in participants with actinic keratoses.
Detailed Description: This is a multicenter, double-blind, vehicle-controlled, parallel group comparison study of a generic fluorouracil cream, 0.5% and Carac (fluorouracil) Cream, 0.5% in participants with actinic keratoses on the full face or balding scalp.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Investigative Site 2, Fremont, California, United States
Investigative Site 16, Los Angeles, California, United States
Investigative Site 17, San Diego, California, United States
Investigative Site 4, Denver, Colorado, United States
Investigative Site 10, Newnan, Georgia, United States
Investigative Site 5, Boise, Idaho, United States
Investigative Site 1, Arlington Heights, Illinois, United States
Investigative Site 11, Buffalo Grove, Illinois, United States
Investigative Site 3, Carmel, Indiana, United States
Investigative Site 9, Plainfield, Indiana, United States
Investigative Site 6, South Bend, Indiana, United States
Investigative Site 8, Clinton Township, Michigan, United States
Investigative Site 13, Warren, Michigan, United States
Investigative Site 12, Fridley, Minnesota, United States
Investigative Site 15, Albuquerque, New Mexico, United States
Investigative Site 7, High Point, North Carolina, United States
Investigative Site 14, Philadelphia, Pennsylvania, United States
Name: Study Director
Affiliation: Actavis Inc.
Role: STUDY_DIRECTOR