Ultraviolet-Induced Change in Normal Skin Clinical Trial
Official title:
UVA Protection Factors of SPF 50 and 50+ Face Sunscreens
The goal of this observational study is to use the International Organization for Standardization (ISO) 24442:2011 in vivo method for assessment of the Ultraviolet A Protection Factor (UVAPF) of topical sunscreen products in healthy adults. The main question it aims to answer is to determine the degree of UVA-protection against UVA radiation. An area of each subject's skin is exposed to UVA light without any protection and another (different) area is exposed after application of the sunscreen product under test. One further area is exposed after application of a reference UVA sunscreen formulation (S2), which is used to validate the procedure.
The objective of the study conducted in accordance with the Declaration of Helsinki and national regulations regarding human studies is to evaluate the UVA protection factor of the investigational products against UVA, according to the ISO 24442:2011 methodology comparatively to a standard product (Standard S2) in healthy adult subjects. Standard reference S2 sunscreen formula is used in a study if any test sample has an expected UVAPF of 12 or above. The mean UVAPF for the reference sample S2 is 12,7. The test result of the reference S2 UVAPF must be between 10,7 and 14,7 or the test is invalid and shall be repeated. The reference S2 may be used to validate any product test. In order to determine the number of subjects, the 95 % confidence interval (CI) shall be taken into account. The 95 % confidence interval should lie within ±17 % of the mean UVAPF, and a minimum of 10 subjects is required. ;
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