Melanoma Clinical Trial
Official title:
Effects of Simulated Solar Radiation on Human Skin
This clinical trial examines the effects of simulated solar radiation on human skin in preventing skin cancer. Testing whether new drugs affect biomarkers in the skin is a good first test of whether the drug might prevent skin cancer. Some biomarkers in skin, and even in moles, are affected after a person is exposed to sunlight. This study may help doctors learn more about what happens to the skin and moles when the participants are exposed to the sun.
PRIMARY OBJECTIVE: I. To identify biomarkers of simulated solar radiation (SSR) treatment in human skin that can be used as surrogate endpoints in chemoprevention trials in humans. SECONDARY OBJECTIVE: I. Measure Langerhans cell (LC) and sunburn cell density in the epidermis, as well as deoxyribonucleic acid (DNA) damage. EXPLORATORY OBJECTIVE I. To perform gene expression analysis on tissue frozen after biopsy. OUTLINE: Patients are randomized to 1 of 3 groups. GROUP I: Patients undergo total body exam. The minimum dose of simulated sunlight required to cause mild sunburn is determined. One of the patient's moles is exposed to 3 times that minimum dose of simulated sunlight. One day later, that mole, and an untreated mole, are removed by punch biopsy. GROUP II: Patients undergo total body exam. The minimum dose of simulated sunlight required to cause mild sunburn is determined. One of the patient's moles is exposed to 4 times that minimum dose of simulated sunlight. One day later, that mole, and an untreated mole, are removed by punch biopsy. GROUP III: Patients undergo total body exam. The minimum dose of simulated sunlight required to cause mild sunburn is determined. One of the patient's moles is exposed to 6 times that minimum dose of simulated sunlight. One day later, that mole, and an untreated mole, are removed by punch biopsy. ;
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