SUV PDL1/PD1 in Sun Damaged & Sun Protected Human Skin of Participants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorUniversity of Arizona
About this trial
The purpose of this research study is to look at how the proteins and genes in people's skin change when they're exposed to simulated sunlight. The researchers want to see if there are differences between people who've had skin cancer and those who haven't despite having a similar type of skin and history of sun exposure. Since this study is designed to simulate sun exposure to small areas of skin, mild to moderate sunburn and tanned spots at the site of the simulated sunlight exposure is a risk. In addition to simulated sun exposure, patients will also have four 6 mm punch skin biopsies performed. Brief discomfort may be felt when the local painkiller (lidocaine) is injected prior to skin biopsies; however, it is usually minimal. Participation in the study involves 4 visits to the clinic over the course of 4 weeks. Each visit will take no longer than 90 minutes.
Eligibility criteria
Qualifiers
Healthy individuals 40 years of age or older. Note: When the two groups are paired, participants will be balanced within 5 years of age. Ex. From 2.5 years younger or 2.5 years older.
Individuals with moderate or severe photodamage of the skin on the forearms and Fitzpatrick skin type II or III (21 CFR 352.72).
Individuals with a history of two or more cSCCs within the past 5 years (maximum of 23 enrolled) or individuals with no history of cSCC (maximum of 23 enrolled)
Females of childbearing potential will need to undergo a pregnancy test at the enrollment visit, after administration of the ICF (informed consent form) and before exposure to solar simulated light (SSL) Premenopausal female subjects must use an effective method of birth control (such as oral contraceptives, consistent use of barrier contraceptives, IUD (intrauterine device), or other proven method of birth control) during study participation. For the purposes of this study, a woman will be considered postmenopausal if any of the following criteria are met: (1) she has had prior bilateral oophorectomy; (2) she is over the age of 60 years; or (3) she is under the age of 60 years and has not had a menstrual period in 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression.
Disqualifiers
Individuals with any inflammation or irritation of the skin at the test areas, or any skin conditions felt by the study healthcare provider to contraindicate enrollment. This includes, but is not limited to, psoriasis or atopic dermatitis within the test areas. (Test area is defined as the 6 mm areas of skin that is exposed to SSL and will be biopsied.)
Individuals with a history of untreated skin cancer or melanocytic lesions in the test areas are ineligible. History of such conditions at a body site other than the test areas is not exclusionary if in the opinion of the study healthcare provider it will not pose a risk to the subject.
Individuals who have had invasive cancer, chemotherapy or radiation therapy within five years of study enrollment
Individuals who are immunosuppressed by virtue of medication or disease. This includes AIDS patients, subjects taking oral steroids, and subjects on immunosuppressants/immunomodulators (cyclosporine, chemotherapeutic agents, or biologic therapy), as determined by the examining study healthcare provider
Trial design
Treatments tested in this trial
- Solar Simulated Light
Treatment groups
46 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Arizona
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov