有替代传统体内SPF测试(ISO 24444)的方法吗?提出的5种方法的比较与统计分析

IF 2.5 4区 医学 Q2 DERMATOLOGY
Marc Pissavini, John Chave, Majella Lane
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引用次数: 0

摘要

在过度暴露在阳光下时,防晒产品在保护消费者皮肤免受紫外线辐射的有害影响方面发挥着关键作用。定期使用这些产品是必不可少的,但同样重要的是要确保向消费者传达的防晒系数(SPF)是准确的,并允许产品之间的一致比较。这一点尤其重要,因为绝大多数消费者的购买决定都是基于标签上显示的SPF值。目前的国际SPF测试标准ISO 24444:2019依赖于对人类志愿者进行的测试。直到2024年,这是唯一被接受的SPF评估方法。然而,这种方法是侵入性的、复杂的、耗时的、昂贵的,而且作为一种生物学测试,具有很高的可变性。多年来,化妆品行业一直在努力开发合适的替代方法,以提供与ISO 24444:2019相当的结果。通过环形测试来验证这些新方法,将新测试方法的结果与金标准进行基准测试。这需要大量防晒产品的体内参考SPF数据的可用性,这是一项重要的实验工作,不能对每种提出的方法重复。认识到这一需求,一个由防晒霜测试用户和开发者组成的联盟于2018年发起了ALT-SPF倡议,以根据ISO 24444:2019黄金标准识别、表征和评估替代防晒霜测试方法。它包括SPF测试方法,这些方法被认为侵入性更小,更精确,更具成本效益。作为这项工作的一部分,ALT-SPF使用32种防晒霜样本进行了广泛的研究。这些测试采用现行的ISO 24444:2019标准和五种替代方法进行测试,包括体外、计算机和非侵入性体内测试方法。每种替代方法都以金标准为基准,并通过统计稳健模型对结果进行分析。这种严格的方法不仅评估了替代方法,而且为ISO于2024年12月发布的两种替代SPF测试方法奠定了基础,这标志着非体内方法首次被正式认可为ISO 24444的可行选择。编辑Majella Lane教授和Marc Pissavini教授荣幸地欢迎欧洲化妆品总干事John Chave先生担任本期《国际化妆品科学杂志》特刊的客座编辑。他的参与强调了合作努力和专业知识在推进SPF测试方法方面的重要性。这个版本有七个开创性的出版物由领先的专家撰写。这些论文详细介绍了ALT-SPF计划的方案、发现和结论。他们的贡献有助于推动SPF测试科学的发展,并塑造一个创新、可靠和合乎道德的方法占据中心地位的未来。我们希望这个特别版能为您提供有关SPF测试未来的深刻见解,并强调合作在推动科学进步中的重要性。我们祝你读得愉快。真诚,编辑器:
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Are there alternatives to the traditional in-vivo SPF test (ISO 24444)? Comparison and statistical analysis of 5 proposed methods

Sun protection products play a critical role in defending consumers' skin against the harmful effects of ultraviolet radiation during sun overexposure. Regular use of these products is essential, but it is equally important to ensure that the sun protection factor (SPF) communicated to consumers is accurate and allows consistent comparison between products. This is particularly vital since the vast majority of consumers base their purchasing decisions on the SPF value displayed on the label.

The current international standard for SPF testing, ISO 24444:2019, relies on testing conducted with human volunteers. Until 2024, this was the sole accepted method for SPF evaluation. However, this approach is invasive, complex, time-consuming, costly, and – as a biological test – has a high variability. Over many years, the cosmetics industry has been working to develop suitable alternative methods that give comparable results to ISO 24444:2019.

Validating such new methods is done through ring tests that benchmark the results of the new test methods against the gold standard. This requires the availability of robust in vivo reference SPF data on a large number of sun protection products – a significant experimental undertaking that cannot be repeated for each proposed method.

Recognizing this need, a consortium of sunscreen testing users and developers launched the ALT-SPF initiative in 2018 to identify, characterize, and evaluate alternative sunscreen testing methods against the ISO 24444:2019 gold standard. It included SPF testing methods that were expected to be less invasive, more precise, and more cost-effective. As part of this effort, ALT-SPF conducted an extensive study using 32 sunscreen samples. These were tested with the current ISO 24444:2019 standard and five alternative methods, including in vitro, in silico, and non-invasive in vivo testing approaches.

Each alternative method was benchmarked against the gold standard, with results analysed through statistically robust models. This rigorous approach not only evaluated the alternative methods but also laid the foundation for ISO's landmark publication in December 2024 of two alternative SPF testing methods – marking the first time non-in vivo approaches have been formally recognized as viable options to ISO 24444.

The editors, Professor Majella Lane and Professor Marc Pissavini, are honoured to welcome Mr. John Chave, Director General of Cosmetics Europe, as the guest editor of this special edition of the International Journal of Cosmetic Science. His participation underscores the importance of collaborative efforts and expertise in advancing SPF testing methodologies.

This edition features seven groundbreaking publications authored by leading experts. These papers detail the protocols, findings, and conclusions of the ALT-SPF initiative. Their contributions have been instrumental in advancing the science of SPF testing and shaping a future where innovative, reliable, and ethical methodologies take centre stage.

We hope this special edition provides you with profound insights into the future of SPF testing and underscores the importance of collaboration in driving scientific progress.

We wish you a pleasant read.

Sincerely,

The editors:

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来源期刊
CiteScore
4.60
自引率
4.30%
发文量
73
期刊介绍: The Journal publishes original refereed papers, review papers and correspondence in the fields of cosmetic research. It is read by practising cosmetic scientists and dermatologists, as well as specialists in more diverse disciplines that are developing new products which contact the skin, hair, nails or mucous membranes. The aim of the Journal is to present current scientific research, both pure and applied, in: cosmetics, toiletries, perfumery and allied fields. Areas that are of particular interest include: studies in skin physiology and interactions with cosmetic ingredients, innovation in claim substantiation methods (in silico, in vitro, ex vivo, in vivo), human and in vitro safety testing of cosmetic ingredients and products, physical chemistry and technology of emulsion and dispersed systems, theory and application of surfactants, new developments in olfactive research, aerosol technology and selected aspects of analytical chemistry.
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