Who Is Conducting The Study?
The National Cancer Institute sponsors this study, which is conducted by the University of Arizona Cancer Center. An Institutional Review Board responsible for human subject’s research at The University of Arizona reviewed this research project and found it to be acceptable, according to applicable state and federal regulations and University policies designed to protect the rights and welfare of participants in research.
What Is The Purpose Of The Study?
The purpose of this study is to analyze changes that occur in skin cells when an emollient cream (moisturizer) is applied to sun damaged skin and Actinic Keratosis twice a day for a period of 3 months. Actinic keratoses (also called AK or precancers) are small, rough scaly spots that do not go away; physicians often treat these areas with liquid nitrogen (freezing).
How Long Is The Study?
Each participant will spend approximately 5 months enrolled in the study. During that time they will come to the research clinic for 4 or 5 study visits.
Who Is Eligible For the Study?
- Men and women, age 18 and older, who:
- Currently have at least 3 actinic keratoses lesions on their forearm or on their scalp
- Have not used topical prescription medications on the forearms, face or scalp in the past 6 months
- Have not had invasive cancer or chemotherapy in the past 5 years
- Are willing to stop applying any products to the skin on the test area during the study period
- Are willing to protect the test areas from sun exposure by wearing protective clothing (long sleeves or a hat) when they spend time outdoors
What Is Required During The Study?
Study participants are asked to provide information about their medical history. Study participants are randomized into one of two different groups; one group applies only the emollient cream provided to them to the test area (forearms or scalp) for 3 months, and the other group applies no skin product whatsoever to the test area for that period of time. Small skin samples (biopsies) are collected from the test area at the beginning of the study and at the end of the 3 month cream application period. A total of 5 biopsies are collected and photographs are taken of the test area.