Effect of Solar-Simulated Ultraviolet Radiation on Gene Expression in Unprotected and Sunscreen-Protected Skin of Healthy Adults With Fitzpatrick Skin Type II
Summary
RATIONALE: Testing of skin that has been exposed to artificial sunlight may help in understanding the genetic processes involved in the development of skin cancer.
PURPOSE: This trial is studying the effect of solar-simulated ultraviolet radiation on skin with or without sunscreen in healthy adults with skin that burns easily after only slight tanning during sun exposure.
Description
OBJECTIVES:
- Determine the global gene expression profiles in epidermal tissue of healthy fair-skinned adults with Fitzpatrick skin type II after exposure to known doses of solar-simulated ultraviolet radiation (ssUVR) (UVA).
- Determine the ability of an FDA-standardized sunscreen to alter ssUVR-induced transcription profiles in vivo in these participants.
- Determine whether the transcriptional profiles of keratinocytes exposed to UVR in cell culture are comparable to the profiles of keratinocytes in skin after similar levels of UVR exposure.
OUTLINE: This is a pilot, dose-response study followed by an in vivo transcriptional profiling study in 2 different groups.
- Pilot study (verification of ultraviolet radiation dose response): Participants are initially exposed to solar-simulated ultraviolet radiation (ssUVR) (UVA) on the back to determine the minimum erythema dose (MED). Between 22-24 hours after exposure, participants undergo shave biopsy from each of the 9 UV exposure sites and 1 unexposed skin site.
- Group 1 (determination of ssUVR and UVA in vivo transcriptional profiles): On day 1, participants are initially exposed to ssUVR on the back to determine the MED. On day 2, participants are exposed to ssUVR (3 sites) and UVA (3 sites) at the MED on the buttocks. Between 22-24 hours after exposure (day 3), participants undergo shave biopsy from each of the 6 UV exposure sites and 2 unexposed skin sites.
- Group 2 (determination of sunscreen-protected in vivo transcriptional profiles): On day 1, participants are initially exposed to ssUVR on the back to determine the MED. On day 2, participants are exposed to ssUVR on unprotected skin (3 sites) and sunscreen-protected skin (3 sites) at the MED on the buttocks. Between 22-24 hours after exposure (day 3), participants undergo shave biopsy from each of the 6 UV exposure sites and 2 unexposed skin sites.
Biopsies from all participants are analyzed by microarray analysis. One of the unexposed epidermal samples is used for primary keratinocyte culture.
PROJECTED ACCRUAL: A total of 6-56 participants (6 for the pilot study and 50 [25 per group] for transcriptional profiling) will be accrued for this study within 2 months.
Study Design
N/A
Conditions
Non-melanomatous Skin Cancer
Intervention
microarray analysis, biopsy, evaluation of cancer risk factors
Location
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda
Maryland
United States
20892-1182
Status
Completed
Source
National Cancer Institute (NCI)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00099112
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Microarray Analysis
The simultaneous analysis, on a microchip, of multiple samples or targets arranged in an array format.
Colorectal Neoplasms
Tumors or cancer of the COLON or the RECTUM or both. Risk factors for colorectal cancer include chronic ULCERATIVE COLITIS; FAMILIAL POLYPOSIS COLI; exposure to ASBESTOS; and irradiation of the CERVIX UTERI.
Tissue Array Analysis
The simultaneous analysis of multiple samples of TISSUES or CELLS from BIOPSY or in vitro culture that have been arranged in an array format on slides or microchips.
Pharmacoepidemiology
The science concerned with the benefit and risk of drugs used in populations and the analysis of the outcomes of drug therapies. Pharmacoepidemiologic data come from both clinical trials and epidemiological studies with emphasis on methods for the detection and evaluation of drug-related adverse effects, assessment of risk vs benefit ratios in drug therapy, patterns of drug utilization, the cost-effectiveness of specific drugs, methodology of postmarketing surveillance, and the relation between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines. (Pharmacoepidemiol Drug Saf 1992;1(1); J Pharmacoepidemiol 1990;1(1))
Causality
The relating of causes to the effects they produce. Causes are termed necessary when they must always precede an effect and sufficient when they initiate or produce an effect. Any of several factors may be associated with the potential disease causation or outcome, including predisposing factors, enabling factors, precipitating factors, reinforcing factors, and risk factors.
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