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Brief Title: Safety and Toleration of PEP005 Topical Gel When Applied to a Treatment Area of up to 100cm2
Official Title: A Multi-center, Open Label, Dose-area Escalation, Cohort Study to Evaluate the Safety and Tolerability of 0.05% PEP005 Topical Gel Applied for Two Consecutive Days to Treatment Area(s) of up to a Total of 100 cm2 in Patients With Actinic Keratoses on the Extensor (Dorsal Aspect) Forearm(s)
Study ID: NCT00659893
Brief Summary: Study Hypothesis: Safety and Tolerability will differ when treating multiple contiguous 25 cm2 treatment areas, as compared to individual 25 cm2 treatment areas.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Radiant Research, Tucson, Arizona, United States
Skin Surgery Medical Group Inc., San Diego, California, United States
Park Avenue Dermatology, Orange Park, Florida, United States
Advanced Dermatology and Cosmetic Surgery, Ormond Beach, Florida, United States
Radiant Research Inc., Pinellas Park, Florida, United States
Medaphase Inc, Newnan, Georgia, United States
Karen S. Harkaway, MD LLC, Delran, New Jersey, United States
J&S Studies, College Station, Texas, United States
St George Dematology and Skin and Cancer Centre, Kogarah, Sydney, New South Wales, Australia
South East Dermatology, Belmont Specialist Centre, Carina Heights, Brisbane, Queensland, Australia
Skin and Cancer Foundation, Carlton, Melbourne, Victoria, Australia
St John of God Dermatology, Subiaco, Perth, Western Australia, Australia
Burswood Dermatology, Victoria Park, Perth, Western Australia, Australia
Name: George Schmieder, DO
Affiliation: Park Avenue Dermatology
Role: PRINCIPAL_INVESTIGATOR
Name: Stephen Shumack, MD
Affiliation: St George Dermatology and Skin and Cancer Centre
Role: PRINCIPAL_INVESTIGATOR