New approach for a reliable in vitro sun protection factor method Part I: Principle and mathematical aspects.

Abstract

Development of an international harmonized in vitro method for sun protection factor (SPF) assessment is currently in progress because of the lack of both reproducibility and accuracy in the current methodology. The aim of this article was to focus on the principle and mathematical aspects (Part I) of a new approach for a reproducible and correlated in vitro test method to obtain results similar to the in vivo SPF for labelling purposes. The currently used in vitro test is based on the spectroradiometric measurement of the residual ultraviolet (UV) transmitted through a thin layer of sunscreen spread on a substrate. To reach the goals of reproducibility and accuracy, the specifications of the key parameters and different steps of the procedure are clearly described in this study. Once reproducibility is obtained with an ad hoc procedure, the accuracy of the SPF values for a large number of products can be demonstrated with the prerequisite of a single UV irradiation dose and a multisubstrate solution. Using a total of 27 samples, the mean coefficient of variation was found to be <10% and the coefficient of correlation with the SPF clinical value reached approximately 0.81. The first part of the article revealed a relevant tool for the in vitro SPF assessment that can be closely correlated to the in vivo SPF for labelling purposes. The second part study will focus on the practical aspects and implementation (Part II) achieved using the present method, will validate the robustness of the models and demonstrate the need to have different product categories to reach a reliable in vitro SPF method adaptable for all products available in the market.