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Brief Title: Study to Determine the Safety of PEP005 0.025% and 0.05% Topical Gel in Patients With Actinic Keratoses
Official Title: A Multi-center, Randomized, Double-blind, Double-dummy, Vehicle-controlled Sequential Cohort Study to Determine the Safety PEP005 0.025% and 0.05% Topical Gel in Patients With Actinic Keratoses.
Study ID: NCT00375739
Brief Summary: The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of actinic keratoses.
Detailed Description: Actinic keratoses (AK) is a common skin condition characterized by rough, scaly patches or sores on the top layer of the skin which if left untreated can progress to skin cancer. Current treatments can cause scarring and hypopigmentation, be inconvenient, or require long treatment duration. Non-invasive alternative therapy for treatment of AK lesions is thus being researched.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Medical Affiliated Research Center, Inc., Huntsville, Alabama, United States
Radiant Research, Tucson, Arizona, United States
Burke Pharmaceutical Research, Hot Springs, Arkansas, United States
Advanced Dermatology and Cosmetic Surgery, Clermont, Florida, United States
Dermatology Associates and Research, Coral Gales, Florida, United States
North Florida Dermatology Associates P.A., Jacksonville, Florida, United States
Park Avenue Dermatology, PA, Orange Park, Florida, United States
Dermatology Associates of Tallahassee, Tallahassee, Florida, United States
Palm Beach Aesthetics, West Palm Beach, Florida, United States
Medaphase, Inc, Newnan, Georgia, United States
Gwinnett Clinical Research Centre, Inc, Snellville, Georgia, United States
Henry Ford Health Center- Farmington Road, West Bloomfield, Michigan, United States
Academic Dermatology Associates, Albuquerque, New Mexico, United States
St. Luke's/Roosevelt Hospital Center Dermatology, New York, New York, United States
Mount Sinai Hospital School of Medicine, New York, New York, United States
University Dermatology Consultants, Inc., Dermatology Clinical Research Center, Cincinnati, Ohio, United States
Radiant Research, Columbus, Ohio, United States
Oregon Medical Research, Centre9495 SW Locust St., Suite G Portland, Oregon, United States
Radiant Research, Anderson, South Carolina, United States
Radiant Research, Greer, South Carolina, United States
Dermatology Clinical Research Center of San Antonio, San Antonio, Texas, United States
Dermatology Associates of Tyler, Tyler, Texas, United States
Dermatology Research Centre, Salt Lake City, Utah, United States
Skokane Dermatology Clinic, PLLP., Spokane, Washington, United States
Name: Lawrence Anderson, Dr
Affiliation:
Role: PRINCIPAL_INVESTIGATOR
Name: Peter Welburn, PhD
Affiliation: Sponsor GmbH
Role: STUDY_CHAIR