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Brief Title: A Multi-center Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on the Head (Face or Scalp)
Official Title: A Multi-center, Randomized, Parallel Group, Double-blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.015% In Patients With Actinic Keratoses ON the Head (Face or Scalp) (REGION-IIa)
Study ID: NCT00916006
Brief Summary: This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when applied to an area of skin containing 4-8 AK lesions on the face or scalp.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Dermatology Research Associates, Los Angeles, California, United States
Dermatology Specialists Inc, Oceanside, California, United States
Skin Surgery Medical Group Inc., San Diego, California, United States
Conant Medical Group, San Francisco, California, United States
University of Miami, Skin Research Camp, Miami, Florida, United States
Atlanta Dermatology, Vein & Research Center, LLC, Alpharetta, Georgia, United States
Medaphase Inc, Newnan, Georgia, United States
Glazer Dermatology, Buffalo Grove, Illinois, United States
Dawes Fretein Clinical Research Group, LLC, Indianapolis, Indiana, United States
Pedia Research LLC, Owensboro, Kentucky, United States
Hamzavi Dermatology, Fort Gratiot, Michigan, United States
Minnesota Clinical Study Center, Fridley, Minnesota, United States
Wake Research Associates, Raleigh, North Carolina, United States
Dermatology Research Associates, Nashville, Tennessee, United States
J & S Studies, Inc., College Station, Texas, United States
Dermatology Associates of Tyler, Tyler, Texas, United States
Center for Clinical Studies, Webster, Texas, United States
Dermatology Research Center, Inc., Salt Lake City, Utah, United States
Virginia Clinical Research, Inc, Norfolk, Virginia, United States
Southderm Pty Ltd, Kogarah, New South Wales, Australia
St George Dematology and Skin Cancer Centre, Kogarah, New South Wales, Australia
Name: Eugene Bauer, MD
Affiliation: Chief Medical Officer
Role: STUDY_DIRECTOR