Quantitative, Biologically Relevant Parameters for Testing and Standardization of Skin Response to UV
The FDA Photosciences Network with contributors in, CDER, Laurel, MD 20708, CDRH, Rockville, MD 20852, CFSAN, Washington, DC 20204, NCTR, Jefferson, AR 72079, NCI/NIH, Bethesda, MD 20892
This study evaluates the utility of novel (both non-invasive and biomarker) methods in assessing skin responses to ultraviolet radiation (UV). Coordinated observations are carried out on humans in CDRH and NCI, guinea pigs and rats in CFSAN, transgenic mice in CDER, and hairless mice in NCTR. The use of comparable methodologies for humans and for animal models makes it possible to assess the validity of cross-species extrapolations related to UV-induced skin damage. This, in turn, should allow us to propose new approaches to the evaluation of the safety and efficacy of UV exposure-related products. Such FDA-regulated products include drugs, sunscreens, cosmetics, and sunlamps. The FDA is currently revising a number of public health policies in this area.