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Establishing a three-dimensional skin model to develop and evaluate the efficacy of photoprotective and anti-aging cosmetic formulations

Grant number: 18/01160-5
Support type:Research Grants - Innovative Research in Small Business - PIPE
Duration: March 01, 2019 - February 28, 2021
Field of knowledge:Health Sciences - Pharmacy
Principal Investigator:ANA LUIZA SCARANO AGUILLERA FORTE
Grantee:ANA LUIZA SCARANO AGUILLERA FORTE
Empresas:Eleve PDI Pesquisa e Desenvolvimento Ltda
ELEVE SCIENCE Pesquisa e Desenvolvimento Ltda
CNAE: Pesquisa e desenvolvimento experimental em ciências físicas e naturais
CNAE: Pesquisa e desenvolvimento experimental em ciências físicas e naturais
City: Ribeirão Preto
Assoc. researchers:Maria José Vieira Fonseca
Associated research grant:16/08453-2 - Establishing a three-dimensional skin model to develop and evaluate the efficacy of photoprotective and anti-aging cosmetic formulations, AP.PIPE
Associated scholarship(s):20/00187-7 - Development and validation of three-dimensional skin models, BP.TT
19/05251-8 - Establishing a three-dimensional skin model to develop and evaluate the efficacy of photoprotective and anti-aging cosmetic formulations, BP.PIPE

Abstract

Alternative methods for the use of animals for safety and efficacy trials are of worldwide interest in various sectors of the economy. A strong political and social movement has forced for decades the search for alternative methods in vitro, such as those that use three-dimensional skin (3D skin), to register products and ingredients for the purpose of evaluating their safety. Regarding the implementation of these models, the cosmetic industry is considered the main responsible for the initial technical and commercial successes with the implementation and validation of tests with this tissue. An important regulatory framework came in 2013 with the ban on the testing of cosmetics using animals in Europe. In Brazil, Anvisa disclosed RN No. 17 of July 3, 2014 where alternative methods validated by the OECD should be applied to cosmetics until September 2019. Regulatory movements are also occurring in other segments such as agrochemical products and hospital medical products. In the first case, through ABNT NBR 14725-2 (2009), it allows the use of skin models validated by the OECD for pesticide registration purposes and in the latter through ISO, 2010. 10993-10: 2010-Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. In addition, the three-dimensional skin model has also demonstrated numerous versatility such as efficacy assessment, as in the evaluation of photoprotectors by detecting the damage produced by ultraviolet radiation. Exposure to ultraviolet radiation (UVR) promotes biological impacts on the skin that can lead to the development of all types of skin cancers, which are very high in prevalence (25% of all tumors in Brazil). The use of sunscreens is singled out as one of the main strategies for reducing UVR damage on the skin as well as cancer. However, the current parameters used to assess photoprotection are not representative for protection against the actual damage to structures and cellular components, including DNA, lipids and proteins, and require studies in volunteers, leading to important disadvantages in the ethical and financial field. In this context, the innovation proposed in this project is the development of a three-dimensional skin platform for performing pre-clinical studies (in vitro model) that encompass studies of (i) safety and (ii) efficacy focusing on the evaluation of photoprotective cosmetic formulations and antiaging. This platform will enable meeting the imminent demands of the market for cosmetic, chemical and medical-hospital products, forced by regulatory and social issues to replace the use of animals in pre-clinical studies for research and registration of products, as well as promote innovation through of obtaining a skin-based three-dimensional product containing melanocytes that surpasses existing products on the international market and which allows a viable evaluation of the effects of photoprotectors and formulations for aging control over human skin. (AU)