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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-IIb)
Study ID: NCT00915551
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
Burke Pharmaceutical Research, Hot Springs, Arizona, United States
Center for Dermatology, Fremont, California, United States
North Florida Dermatology Associates, PA, Jacksonville, Florida, United States
Altman Dermatology Associates, Arlington Heights, Illinois, United States
Laser Skin Surgery Center of Indiana, Carmel, Indiana, United States
Deaconess Clinic, Inc, Evansville, Indiana, United States
The Indiana Clinical Trials Center, PC, Plainfield, Indiana, United States
Skin Specialists, PC, Omaha, Nebraska, United States
Karl G. Heine Dermatology, Henderson, Nevada, United States
Academic Dermatology Associates, Albuquerque, New Mexico, United States
Mount Sinai School of Medicine, New York, New York, United States
Dermatology Associates of Rochester, PC, Rochester, New York, United States
Dermatology, Laser Vein Specialists of the Carolinas, Charlotte, North Carolina, United States
Oregon Medical Research Center, PC, Portland, Oregon, United States
DermResearch, Inc., Austin, Texas, United States
Suzanne Bruce and Associates, PA, The Center for Skin Research, Houston, Texas, United States
Progressive Clinical Research, San Antonio, Texas, United States
The Education and Research Foundation, Lynchburg, Virginia, United States
Premier Clinical Research, Spokane, Washington, United States
The Skin Centre, Benowa, Queensland, Australia
South East Dermatology, Belmont Specialist Centre, Carina Heights, Queensland, Australia