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Sunscreen sensory attribute prediction via textural, rheological and tribological tests. 通过纹理、流变学和摩擦学测试预测防晒霜的感官属性。
IF 2.5 4区 医学 Q2 DERMATOLOGY Pub Date : 2025-09-04 DOI: 10.1111/ics.70021
Günel Nabiyeva, Baran Teoman, Andrei Potanin, Gennady Y Gor

This study aims to find the quick ways to predict sensorial attributes of sunscreens using instrumental measurements. We specifically focus on the attributes most relevant to consumer 'liking' and the easiest measurements to implement in industrial labs for product development. Of the latter, we consider three types of measurements: emulative 'textural' tests typically performed with a texture analyser as well as rheological and tribological measurements. Textural tests are generally preferred but may be paralleled by rheological measurements provided they are implementable on simple viscometers used in industry (albeit with additional data processing). We found that both textural and simple rheological/viscometrical tests work well for predicting sensorial attributes about flow before (thickness) and during (spreadability) application of the products. Tribology provides useful additional information for the latter but is primarily useful for after-feel or residue attributes (absorption and skin stickiness). These findings show that simple lab tests relying on these techniques can predict human sensory attributes, thus efficiently guide product developers while reducing the need for costly and time-consuming panel studies.

本研究旨在通过仪器测量,找到快速预测防晒霜感官属性的方法。我们特别关注与消费者“喜欢”最相关的属性,以及最容易在工业实验室实施的产品开发测量。对于后者,我们考虑了三种类型的测量:模拟“纹理”测试,通常使用纹理分析仪进行,以及流变学和摩擦学测量。纹理测试通常是首选,但也可以与流变测量并行,前提是它们可以在工业中使用的简单粘度计上实现(尽管需要额外的数据处理)。我们发现,质地和简单的流变/粘度测试都可以很好地预测产品应用前(厚度)和应用期间(涂抹性)的流动感官属性。摩擦学为后者提供了有用的附加信息,但主要用于后感或残留属性(吸收和皮肤粘性)。这些发现表明,依靠这些技术的简单实验室测试可以预测人类的感官属性,从而有效地指导产品开发人员,同时减少对昂贵和耗时的面板研究的需要。
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引用次数: 0
Test design and results of a method performance characterization study for SPF and UVA-PF testing SPF和UVA-PF测试方法性能表征研究的试验设计和结果
IF 2.5 4区 医学 Q2 DERMATOLOGY Pub Date : 2025-09-01 DOI: 10.1111/ics.70019
Bertrand Colson, Jürgen Vollhardt, Curtis Cole, Ludger Kolbe, Paul Matts, Benoit Muller, Luciano Nogueira, Sergio Oliveira, Marc Pissavini, Florence Pouradier, Gerald Renner, Mathias Rohr, Eduardo Ruvolo, Caroline Tricaud, ALT-SPF Consortium, Steffen Uhlig

Objective

This paper presents the experimental design, the statistical model, performance criteria and results of a method performance study conducted in order to characterize the performance of alternative methods for SPF and UVA-PF testing. The performance of alternative methods is characterized against the performance of the ISO 24444 and ISO 24443 methods.

Methods

A factorial experimental design was implemented. For a given method, such a design allows good statistical reliability of precision estimates with as few as four participating laboratories. To cover the wide range of sunscreen products on the market, 32 sunscreens were tested. These 32 products were classified into eight product groups. The product groups differ in terms of SPF level, application viscosity and type of UV filters and matrix. In co-operation with a WG7 ISO ad hoc group performance criteria for the alternative methods were developed for reproducibility precision, between-laboratory variation, bias and the variation of bias across products and across product groups.

Results

Performance characteristics for the reference method along with reproducibility and repeatability limits are provided. The results for the participating alternative methods will be presented in separate articles, following this paper.

Conclusions

The precision of ISO 24444 and ISO 24443 was characterized for each of the eight product groups. The main sources of variation were identified for each of the two reference methods. Reproducibility and repeatability limits were derived and are provided.

目的介绍SPF和UVA-PF两种测试方法的实验设计、统计模型、性能标准和测试结果。替代方法的性能与ISO 24444和ISO 24443方法的性能相比较。方法采用因子试验设计。对于一个给定的方法,这样的设计允许只有四个参与实验室的精度估计具有良好的统计可靠性。为了覆盖市场上各种各样的防晒产品,我们对32种防晒霜进行了测试。这32种产品被分为8个产品组。产品组在SPF级别,应用粘度和紫外线过滤器和基质的类型方面有所不同。与WG7 ISO特设小组合作,开发了可选方法的可重复性精度,实验室间差异,偏差以及产品和产品组之间偏差的变化。结果提供了参考方法的性能特征及重现性和重复性限制。参与替代方法的结果将在本文之后的单独文章中介绍。结论ISO 24444和ISO 24443对8个产品组的精密度进行了表征。确定了两种参考方法的主要变异源。推导并给出了再现性和重复性极限。
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引用次数: 0
Are there alternatives to the traditional in-vivo SPF test (ISO 24444)? Comparison and statistical analysis of 5 proposed methods 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 Pub Date : 2025-09-01 DOI: 10.1111/ics.70026
Marc Pissavini, John Chave, Majella Lane

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 in

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:
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引用次数: 0
Characterization of LED-based hybrid diffuse reflectance spectroscopy method for determination of SPF and UVA-PF in blinded multi-centre study (ALT-SPF) 基于led的混合漫反射光谱法测定SPF和UVA-PF的盲法多中心研究(ALT-SPF)
IF 2.5 4区 医学 Q2 DERMATOLOGY Pub Date : 2025-09-01 DOI: 10.1111/ics.70007
Carina Reble, Michael Bayer, Bertrand Colson, Tanja Emmler, Jean-Claude Hubaud, Matthias Seise, Eva Perroux-David, Georg Wiora, Daniela F. Zamudio Diaz, ALT-SPF Consortium, Martina C. Meinke, Stephan Bielfeldt

Objective

The consortium ALT-SPF performed an international round robin test to characterize non-invasive methods as alternatives to the erythema-based testing of sun protection factor (SPF) according to ISO 24444:2019.

Methods

Hybrid diffuse reflectance spectroscopy (HDRS) based on a multi-lambda LED light source uses in vivo reflectance spectra on skin to determine sunscreens in vivo absorbance spectra, which are fused with respective in vitro absorbance spectra measured as thin films transmission as described in ISO 24443:2019. As a part of the ALT-SPF consortium initiative, a blinded study on 64 samples was performed in four European laboratories. After further improvements of the method, a blinded re-evaluation based on 16 samples was performed. Five statistical acceptance criteria for new methods were assessed by an independent statistical institute to compare the obtained results to the reference methods for SPF and UVA-PF.

Results

The initial ALT-SPF study 1 showed that the bias criterion was acceptable, while the reproducibility and interlaboratory variability needed further improvement. The re-evaluation study 2 showed that the reproducibility and interlaboratory variability could be considerably improved. Using only n = 10 volunteers and a bias correction based on the initial ALT-SPF study 1 data, the SPF results of the re-evaluation study 2 were close to the acceptance criteria of the ALT-SPF study with criterion 1 (reproducibility) and only 11% over the limit defined by the performance of the gold standard. The UVA-PF results were within the acceptance limits for the acceptance criteria, except criterion 3 being in the ‘almost met’ range. The re-evaluation study indicates that the method has a comparable precision to the gold standard methods ISO 24444 and ISO 24443.

Conclusion

This study showed that the LED-HDRS method is capable of providing reasonable non-invasive SPF and UVA-PF results and that the performance shows close alignment to the reference method. Thus, it can be proposed as an alternative method to the current standards ISO 24444 and ISO 24443.

目的ALT-SPF联盟根据ISO 24444:2019进行了一项国际循环试验,以表征非侵入性方法作为基于红斑的防晒系数(SPF)测试的替代方法。方法基于多λ LED光源的混合漫反射光谱(HDRS)利用皮肤上的体内反射光谱测定防晒霜的体内吸收光谱,并将其与ISO 24443:2019中以薄膜透射方式测量的各自体外吸收光谱融合。作为ALT-SPF联盟倡议的一部分,在四个欧洲实验室对64个样本进行了盲法研究。在进一步改进方法后,对16个样本进行盲法再评价。由独立的统计机构评估新方法的5个统计可接受标准,将所得结果与SPF和UVA-PF的参考方法进行比较。结果初步的ALT-SPF研究1表明,偏倚标准是可以接受的,但重复性和实验室间变异性有待进一步改进。重新评价研究2表明,可重复性和实验室间变异性可显著改善。仅使用n = 10名志愿者,并基于初始ALT-SPF研究1的数据进行偏倚校正,重新评估研究2的SPF结果接近ALT-SPF研究标准1(可重复性)的接受标准,仅超过金标准性能定义的极限11%。UVA-PF结果在接受标准的接受范围内,除了标准3处于“几乎满足”的范围。重新评价研究表明,该方法的精密度与金标准方法ISO 24444和ISO 24443相当。结论本研究表明,LED-HDRS方法能够提供合理的无创SPF和UVA-PF结果,其性能与参考方法接近。因此,它可以作为现行标准ISO 24444和ISO 24443的替代方法提出。
{"title":"Characterization of LED-based hybrid diffuse reflectance spectroscopy method for determination of SPF and UVA-PF in blinded multi-centre study (ALT-SPF)","authors":"Carina Reble,&nbsp;Michael Bayer,&nbsp;Bertrand Colson,&nbsp;Tanja Emmler,&nbsp;Jean-Claude Hubaud,&nbsp;Matthias Seise,&nbsp;Eva Perroux-David,&nbsp;Georg Wiora,&nbsp;Daniela F. Zamudio Diaz,&nbsp;ALT-SPF Consortium,&nbsp;Martina C. Meinke,&nbsp;Stephan Bielfeldt","doi":"10.1111/ics.70007","DOIUrl":"https://doi.org/10.1111/ics.70007","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>The consortium ALT-SPF performed an international round robin test to characterize non-invasive methods as alternatives to the erythema-based testing of sun protection factor (SPF) according to ISO 24444:2019.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Hybrid diffuse reflectance spectroscopy (HDRS) based on a multi-lambda LED light source uses in vivo reflectance spectra on skin to determine sunscreens in vivo absorbance spectra, which are fused with respective in vitro absorbance spectra measured as thin films transmission as described in ISO 24443:2019. As a part of the ALT-SPF consortium initiative, a blinded study on 64 samples was performed in four European laboratories. After further improvements of the method, a blinded re-evaluation based on 16 samples was performed. Five statistical acceptance criteria for new methods were assessed by an independent statistical institute to compare the obtained results to the reference methods for SPF and UVA-PF.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The initial ALT-SPF study 1 showed that the bias criterion was acceptable, while the reproducibility and interlaboratory variability needed further improvement. The re-evaluation study 2 showed that the reproducibility and interlaboratory variability could be considerably improved. Using only <i>n</i> = 10 volunteers and a bias correction based on the initial ALT-SPF study 1 data, the SPF results of the re-evaluation study 2 were close to the acceptance criteria of the ALT-SPF study with criterion 1 (reproducibility) and only 11% over the limit defined by the performance of the gold standard. The UVA-PF results were within the acceptance limits for the acceptance criteria, except criterion 3 being in the ‘almost met’ range. The re-evaluation study indicates that the method has a comparable precision to the gold standard methods ISO 24444 and ISO 24443.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>This study showed that the LED-HDRS method is capable of providing reasonable non-invasive SPF and UVA-PF results and that the performance shows close alignment to the reference method. Thus, it can be proposed as an alternative method to the current standards ISO 24444 and ISO 24443.</p>\u0000 </section>\u0000 </div>","PeriodicalId":13936,"journal":{"name":"International Journal of Cosmetic Science","volume":"47 S1","pages":"96-114"},"PeriodicalIF":2.5,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/ics.70007","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144923565","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Performance of hybrid diffuse reflectance spectroscopy (HDRS-ISO 23698) methodology for assessment of sunscreen protection in the ALT-SPF Consortium validation study 混合漫反射光谱(HDRS-ISO 23698)方法在ALT-SPF联盟验证研究中用于防晒霜防护评估的性能
IF 2.5 4区 医学 Q2 DERMATOLOGY Pub Date : 2025-09-01 DOI: 10.1111/ics.13089
Eduardo Ruvolo, Curtis Cole, Mathias Rohr, Jay Silverman, Omid Yousefian, Jan Batzer, Nele Lange, Rita Touti, Florence Pouradier, Luciano Nogueira, Bertrand Colson

Objective

Alternative methods to the traditional in vivo sun protection factor (SPF) test are desirable for many reasons. Hybrid DRS (HDRS) (combining in vitro transmission spectroscopy with in vivo DRS spectroscopy) was used in an extensive ring study to characterize its ability to estimate topical sunscreen protection and compared with the currently recognized ‘gold standard’ human in vivo Sun Protection Factor (SPF-ISO24444), Ultraviolet-A Protection Factor (UVA-PF), and Critical Wavelength (CW) (ISO 24443) Reference Methods sponsored by the Alternative SPF Consortium.

Methods

Diffuse reflectance spectroscopy (DRS) of skin provides a rapid, convenient non-invasive tool to evaluate skin properties as well as the optical properties of materials applied to the skin, such as sunscreens. DRS methodology combines in vivo measurement of sunscreen absorbance on skin in the Ultraviolet A (UVA) region with full spectrum in vitro spectrophotometric absorbance scans to provide a full spectrum measurement of the protection of sunscreen on skin.

Results

Results from testing with both monochromatic and polychromatic HDRS devices provided strong correlation of SPF, UVA-PF and Critical Wavelength results with their corresponding ‘gold standard’ counterpart methods in Study 1 for bias (or ‘accuracy’), however with more variability within certain product types. Further training of personnel conducting the HDRS studies was conducted prior to a second follow-up ring study using many of the same blinded samples from Study 1 in addition to Reference Standard sunscreens.

Conclusions

The results showed marked improvement in the variability to a level equivalent to the reference methods while maintaining accuracy of the estimates of the protection values. Virtually all estimates were within the Prediction Intervals (PI) of the reference methods for the second study. HDRS offers the ability to accurately assess sunscreen performance for SPF, UVA-PF as well as CW without invasive damage to test subjects and offers in the future the opportunity to assess water resistance performance.

目的:由于多种原因,人们需要替代传统体内防晒系数(SPF)测试的方法。混合DRS (HDRS)(结合体外透射光谱和体内DRS光谱)在一项广泛的环研究中使用,以表征其评估局部防晒霜保护的能力,并与目前公认的“金标准”人体体内防晒系数(SPF-ISO24444)、紫外线a保护系数(UVA-PF)、和临界波长(CW) (ISO 24443)参考方法由Alternative SPF Consortium发起。方法皮肤漫反射光谱(DRS)技术是一种快速、方便、无创的方法,可用于评估皮肤特性以及涂抹在皮肤上的材料(如防晒霜)的光学特性。DRS方法结合了紫外线A (UVA)区域防晒霜对皮肤吸收的体内测量和全光谱体外分光光度法吸收扫描,提供了防晒霜对皮肤保护的全光谱测量。单色和多色HDRS设备的测试结果表明,SPF、UVA-PF和临界波长结果与研究1中相应的“金标准”对应方法的偏差(或“准确性”)有很强的相关性,但在某些产品类型中存在更多的可变性。在第二次后续环研究之前,对开展HDRS研究的人员进行了进一步培训,该研究使用了许多与研究1中相同的盲法样本,并使用了参考标准防晒霜。结论结果表明,在保持保护值估计准确性的同时,变异率显著提高到与参考方法相当的水平。几乎所有的估计都在第二项研究的参考方法的预测区间(PI)内。HDRS提供了准确评估SPF、UVA-PF和CW防晒性能的能力,而不会对测试对象造成侵入性损害,并在未来提供了评估防水性能的机会。
{"title":"Performance of hybrid diffuse reflectance spectroscopy (HDRS-ISO 23698) methodology for assessment of sunscreen protection in the ALT-SPF Consortium validation study","authors":"Eduardo Ruvolo,&nbsp;Curtis Cole,&nbsp;Mathias Rohr,&nbsp;Jay Silverman,&nbsp;Omid Yousefian,&nbsp;Jan Batzer,&nbsp;Nele Lange,&nbsp;Rita Touti,&nbsp;Florence Pouradier,&nbsp;Luciano Nogueira,&nbsp;Bertrand Colson","doi":"10.1111/ics.13089","DOIUrl":"https://doi.org/10.1111/ics.13089","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>Alternative methods to the traditional in vivo sun protection factor (SPF) test are desirable for many reasons. Hybrid DRS (HDRS) (combining in vitro transmission spectroscopy with in vivo DRS spectroscopy) was used in an extensive ring study to characterize its ability to estimate topical sunscreen protection and compared with the currently recognized ‘gold standard’ human in vivo Sun Protection Factor (SPF-ISO24444), Ultraviolet-A Protection Factor (UVA-PF), and Critical Wavelength (CW) (ISO 24443) Reference Methods sponsored by the Alternative SPF Consortium.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Diffuse reflectance spectroscopy (DRS) of skin provides a rapid, convenient non-invasive tool to evaluate skin properties as well as the optical properties of materials applied to the skin, such as sunscreens. DRS methodology combines in vivo measurement of sunscreen absorbance on skin in the Ultraviolet A (UVA) region with full spectrum in vitro spectrophotometric absorbance scans to provide a full spectrum measurement of the protection of sunscreen on skin.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Results from testing with both monochromatic and polychromatic HDRS devices provided strong correlation of SPF, UVA-PF and Critical Wavelength results with their corresponding ‘gold standard’ counterpart methods in Study 1 for bias (or ‘accuracy’), however with more variability within certain product types. Further training of personnel conducting the HDRS studies was conducted prior to a second follow-up ring study using many of the same blinded samples from Study 1 in addition to Reference Standard sunscreens.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>The results showed marked improvement in the variability to a level equivalent to the reference methods while maintaining accuracy of the estimates of the protection values. Virtually all estimates were within the Prediction Intervals (PI) of the reference methods for the second study. HDRS offers the ability to accurately assess sunscreen performance for SPF, UVA-PF as well as CW without invasive damage to test subjects and offers in the future the opportunity to assess water resistance performance.</p>\u0000 </section>\u0000 </div>","PeriodicalId":13936,"journal":{"name":"International Journal of Cosmetic Science","volume":"47 S1","pages":"53-77"},"PeriodicalIF":2.5,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/ics.13089","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144923568","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The ALT-SPF ring study – in vitro determination of the SPF & UVA-PF by the fused method ALT-SPF环的研究——用融合法体外测定SPF和UVA-PF
IF 2.5 4区 医学 Q2 DERMATOLOGY Pub Date : 2025-09-01 DOI: 10.1111/ics.70015
S. Acker, A. Büchse, L. Nogueira, J. Zur Lage, E. Perroux-David, F. Drulhon, J. Moraes, S. Peters, A. Janssen, N. M. Komjani, B. Colson, B. Herzog

Objective

In the framework of the Alt-SPF consortium, a large ring study was conducted to evaluate different alternative methods for SPF determination. This paper reports and discusses the results of a new in vitro approach, the Fused Method. The study aimed to determine whether the Fused Method would provide similar SPF results to those obtained using ISO 24444 and whether UVA-PF would be comparable to ISO 24443.

Methods

The Fused Method is based on assessing UV transmittance through a film of sunscreen applied to PMMA plates, before and after 1MED irradiation through the film. An individual calibration curve is measured by each operator using standard sunscreens to correct for individual/equipment error throughout the process. This calibration is formulation-dependent: there is one calibration for emulsion, one for single-phase formulations, and one for mineral UV filters.

Results

Optimization of the calibration step to an asymptotic regression model improved inter-laboratory reproducibility and showed lower method bias compared to ISO 24444. Most PGs met the full statistical validation criterion for SPF results. The results of PG1 (low viscosity emulsion SPF30), PG2 (medium viscosity emulsion SPF6) and PG4 (medium viscosity emulsion SPF30) indicate a product and product group-specific method bias. This observation was confirmed for PG1 in the follow-up study. The same conclusion could be drawn for the evaluation of UVA-PF versus ISO 24443, as this parameter is directly linked to the SPF results.

Conclusion

The use of the Fused Method to determine the SPF of sunscreen formulations meets the statistical criteria for most PGs. However, intra-laboratory reproducibility needs to be improved for low SPF values and low viscosity emulsions. Nevertheless, this fast, simple, and cost-effective method remains a good alternative for SPF & UVA-PF screening in the development of sunscreen formulations. It is a pragmatic approach to manage the various known biases (applicator/device) of in vitro transmittance SPF measurement. No significant change to ISO 24443 is required, and the method allows in vitro SPF & UVA-PF to be determined in the same setup.

目的在Alt-SPF联盟的框架下,进行了一项大型环研究,以评估SPF测定的不同替代方法。本文报道并讨论了一种新的体外方法——融合法的结果。该研究旨在确定融合方法是否能提供与ISO 24444相似的SPF结果,以及UVA-PF是否能与ISO 24443相媲美。方法熔融法是基于在PMMA板上涂上一层防晒膜,在通过薄膜进行1MED照射之前和之后,评估紫外线透过薄膜的透射率。每个操作人员使用标准防晒霜测量单独的校准曲线,以纠正整个过程中的个人/设备误差。此校准与配方相关:乳液有一个校准,单相配方有一个校准,矿物紫外线过滤器有一个校准。结果与ISO 24444相比,将校准步骤优化为渐近回归模型,提高了实验室间的可重复性,降低了方法偏差。大多数pg符合SPF结果的完全统计验证标准。PG1(低黏度乳液SPF30)、PG2(中黏度乳液SPF6)和PG4(中黏度乳液SPF30)的结果显示了产品和产品组特定的方法偏差。这一观察结果在PG1的后续研究中得到了证实。对于UVA-PF与ISO 24443的比较,也可以得出同样的结论,因为该参数与SPF结果直接相关。结论采用融合法测定防晒霜配方的SPF值符合大多数产品的统计标准。然而,对于低SPF值和低粘度乳剂,实验室内的再现性需要改进。尽管如此,这种快速、简单、经济的方法仍然是在开发防晒霜配方时筛选SPF和UVA-PF的一个很好的选择。这是一种实用的方法来管理各种已知的偏差(涂抹器/设备)的体外透射率SPF测量。不需要对ISO 24443进行重大更改,并且该方法允许在相同的设置中确定体外SPF和UVA-PF。
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引用次数: 0
Performance assessment of the Double Plate method (ISO23675) in ALT-SPF Consortium: A highly reproducible and accurate in vitro method to determine SPF ALT-SPF联盟双板法(ISO23675)的性能评价:一种高重复性、高准确度的体外SPF测定方法
IF 2.5 4区 医学 Q2 DERMATOLOGY Pub Date : 2025-09-01 DOI: 10.1111/ics.13088
Florence Pouradier, Sebastien Miksa, Jan Batzer, Modibo Mangassi, Anna Ludwikowska, Hicham Nocairi, Bertrand Colson, Gerald Renner, Paul J. Matts, Marc Pissavini

Objective

To perform a comprehensive statistical characterization of the Double Plate method (ISO 23675) as a potential in vitro alternative to the in vivo reference method (ISO 24444:2019) for determining the sun protection factor (SPF).

Methods

Five qualified laboratories were involved in testing the Double Plate method, as part of a large-scale ring test conducted by the International Consortium ‘ALT-SPF’. About 32 sunscreen products, reflecting diverse global formulations, were tested using both the in vivo reference method and the Double Plate method. This method employs spectrophotometric measurements of sunscreen applied to UV-transparent plates with standardized robotic application to minimize the variability. A mathematical adjustment was introduced to address the initial bias compared to the reference method and further assessed in a follow-up ring test with 12 products, including ISO standards.

Results

The Double Plate method exhibited very high intra- and inter-laboratory reproducibility throughout the study, consistently meeting the precision criteria set by ISO/TC217/WG7. Following the mathematical adjustment, the accuracy significantly improved, demonstrating a close alignment with the reference method.

Conclusion

The Double Plate method demonstrates excellent reproducibility and, following optimization, high accuracy for the SPF determination. These findings endorse the Double Plate method as a robust and ethical in vitro alternative to the in vivo reference method for SPF testing. This paved the way for its publication as a new ISO standard (ISO 23675), in December 2024, supporting consumer safety and informed product choices.

目的对双板法(ISO 23675)作为体内参考法(ISO 24444:2019)测定防晒系数(SPF)的潜在体外替代方法进行综合统计表征。方法在国际联盟“ALT-SPF”进行的大规模环试验中,有5个合格的实验室参与双板法的试验。大约32种防晒产品,反映了不同的全球配方,使用体内参考法和双板法进行了测试。该方法采用分光光度法测量防晒霜应用于紫外线透明板与标准化的机器人应用,以尽量减少可变性。引入数学调整来解决与参考方法相比的初始偏差,并在后续的12种产品(包括ISO标准)的环形测试中进一步评估。结果双板法在整个研究过程中具有非常高的实验室内和实验室间重复性,始终符合ISO/TC217/WG7设定的精密度标准。经数学平差后,精度显著提高,与参考方法接近。结论双板法重现性好,经优化后具有较高的SPF测定准确度。这些发现支持双板法作为一个可靠的和道德的体外替代在体内的参考方法进行SPF测试。这为其作为新的ISO标准(ISO 23675)于2024年12月发布铺平了道路,支持消费者安全和知情的产品选择。
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引用次数: 0
The ALT-SPF ring study—Correlation in silico versus in vivo SPF ISO24444 and in vitro UVA-PF ISO24443 ALT-SPF环的研究-硅与体内SPF ISO24444和体外UVA-PF ISO24443的相关性
IF 2.5 4区 医学 Q2 DERMATOLOGY Pub Date : 2025-09-01 DOI: 10.1111/ics.13086
Gernot Kunze, Myriam Sohn, Jochen Giesinger, Katja Quass, Yvonne Prigl, Caithlyn Schleiger, Alexander Schlifke, Waldemar Ens, Frauke Wilfert, Jürgen Vollhardt, Bertrand Colson, Bernd Herzog

This paper presents the results of the Alt-SPF consortium ring test, obtained by the in-silico methodology, and discusses these results in the context of existing standards. To evaluate the effectiveness of the in-silico methodology in correlating with these standards, a comparison was made between the in-silico sun protection factor (SPF) and the UVA protection factor (UVA-PF) and the values derived by standard in vivo SPF (ISO24444) and in vitro UVA-PF (ISO24443). The model utilises the same algorithm as in vitro measurements of SPF and UVA-PF, with the measured UV transmission substituted by calculated transmission simulated through an applied sunscreen film. The in-silico approach necessitates quantitative UV absorbance data of all UV-filters, their photodegradation and photointeraction properties, oil/water phase synergies and a model describing the irregular distribution of the film thickness on the skin. The performance factors are calculated using an initial analytical evaluation of the 32 test formulations of the ring test, to ascertain the presence and concentration of individual UV absorbers. The filter concentrations obtained are then processed via computational analysis to calculate the SPF and UV-PF values. It has been demonstrated that, in accordance with defined statistical parameters to characterize the ability of a method to correlate with the in vivo SPF standard, the in-silico methodology is a highly reproducible and accurate tool for SPF prediction. The alignment with the lowest measured in vivo SPF values serves to ensure the safety of the end consumer and is not a weakness of the method. Additionally, it has been demonstrated that the methodology facilitates precise prediction of UVA protection in comparison to the in vitro standard ISO 24443. These calculations can be employed to engineer novel sunscreens, thereby diminishing the necessity for ethically questionable and extensive laboratory measurements. In case still in-vivo measurements are needed, the methodology can deliver the frequently required SPF/UVA-PF values and may also support functions such as those of responsible persons, including safety assessors, in their evaluations.

本文介绍了通过硅片方法获得的Alt-SPF联盟环测试的结果,并在现有标准的背景下讨论了这些结果。为了评估计算机方法与这些标准相关性的有效性,我们比较了计算机防晒系数(SPF)和UVA防护系数(UVA- pf)以及体内标准SPF (ISO24444)和体外标准UVA- pf (ISO24443)得出的值。该模型采用与体外测量SPF和UVA-PF相同的算法,通过应用防晒膜模拟计算透射率来取代测量的紫外线透射率。硅片方法需要所有紫外线滤光器的定量紫外吸收数据、它们的光降解和光相互作用特性、油/水相协同作用以及描述薄膜厚度在皮肤上不规则分布的模型。性能因子是通过对环形试验的32种试验配方的初步分析评估来计算的,以确定单个紫外线吸收剂的存在和浓度。然后通过计算分析对得到的滤光剂浓度进行处理,以计算SPF和UV-PF值。已经证明,根据定义的统计参数来表征一种方法与体内SPF标准相关的能力,该方法是一种高度可重复和准确的SPF预测工具。与体内最低SPF值的校准有助于确保最终消费者的安全,并不是该方法的弱点。此外,与体外标准ISO 24443相比,已证明该方法有助于精确预测UVA防护。这些计算可以用于设计新型防晒霜,从而减少了伦理问题和广泛的实验室测量的必要性。如果仍然需要进行体内测量,该方法可以提供经常需要的SPF/UVA-PF值,并且还可以支持责任人(包括安全评估人员)的评估功能。
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引用次数: 0
Sustainable cosmetic ingredient alternatives to replace conventional ingredients: Case studies in moisturizers and lipsticks. 替代传统成分的可持续化妆品成分替代品:润肤霜和口红的案例研究。
IF 2.5 4区 医学 Q2 DERMATOLOGY Pub Date : 2025-08-19 DOI: 10.1111/ics.70020
Anna Spaulding, Gabriella Baki

Objective: Over the last two decades, consumers have been calling for greater transparency for ingredient sourcing and manufacturing practices; therefore, more sustainable alternatives need to be evaluated to meet industry demands. While many organizations give standards for 'clean', 'organic' and 'natural' cosmetic products, sustainable formulations lack standardization and harmonization globally. This study aimed to formulate sustainable lipsticks and moisturizers using resources and standards currently available in the cosmetic industry and compare select sustainable alternatives to a conventional control product.

Methods: After thoroughly screening ingredients for each product type, five different lipsticks and five batches of moisturizers were formulated and tested for quality, performance and stability characteristics.

Results: Pay-off and friction were the most different among the lipsticks, with M4, the lipstick containing sustainable ingredients, having the highest average friction and pay-off at Week 1. As for the moisturizers, spreadability had the largest differences, mostly due to the different emulsifier systems, as expected.

Conclusion: Incorporating sustainable ingredients can be challenging, but having quality products while being more environmentally friendly is possible. These case studies are meant to serve as examples for formulation chemists.

目标:在过去的二十年中,消费者一直在呼吁提高原料采购和生产实践的透明度;因此,需要评估更可持续的替代方案,以满足行业需求。虽然许多组织制定了“清洁”、“有机”和“天然”化妆品的标准,但可持续配方缺乏全球标准化和协调。本研究旨在利用化妆品行业现有的资源和标准制定可持续唇膏和保湿剂,并将选择的可持续替代品与传统对照产品进行比较。方法:对每个产品类型的成分进行彻底筛选后,配制5种不同的口红和5批保湿霜,并对其质量、性能和稳定性进行测试。结果:效果和摩擦力在不同的口红中差异最大,含有可持续成分的M4在第1周的平均摩擦力和效果最高。至于保湿霜,涂抹性有最大的差异,主要是由于不同的乳化剂系统,正如预期的那样。结论:采用可持续的成分可能是具有挑战性的,但拥有高质量的产品,同时更环保是可能的。这些案例研究旨在为配方化学家提供示例。
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引用次数: 0
Evaluation of the sensitive skin syndrome and the effect of a dermo-cosmetic treatment in Thai and Polish subjects. 评估泰国和波兰受试者的敏感皮肤综合征和皮肤美容治疗的效果。
IF 2.5 4区 医学 Q2 DERMATOLOGY Pub Date : 2025-08-19 DOI: 10.1111/ics.70017
Helena Polena, Sylwia Czaińska, Benoît Cadars, Ewa Chlebus, Monika Serafin, Waranya Boonchai, Pichanee Chaweekulrat, Silada Kanokrungsee, Marlène Chavagnac-Bonneville, Christelle Graizeau, Michèle Sayag, Elodie Prestat-Marquis

Objective: Sensitive skin syndrome (SSS) affects individuals from all ethnic groups. However, studies across different populations remain limited, despite recognised differences between populations. Thus, we examined SSS in Thai and Polish subjects, assessing the tolerance and efficacy of a dermo-cosmetic product in both populations.

Methods: Thai participants were involved in a 28-day open-label study, while Polish subjects took part in a 56-day double-blind, randomised study comparing the product with a control cream. Clinical and functional signs were evaluated, alongside quality of life (QoL) using the Burden of Sensitive Skin (BoSS) questionnaire.

Results: The product was well tolerated in both groups over time, leading to significant improvements in all clinical and functional signs (p < 0.05 to p < 0.001) and enhancing QoL (p < 0.005 in Thailand; p < 0.001 in Poland). At baseline, Polish subjects exhibited greater redness and higher BoSS scores to questions relating to visual signs (p < 0.001). Conversely, Thai participants reported more pronounced tingling, pain and itching, along with higher BoSS scores relating to sensory symptoms (p < 0.001).

Conclusions: The study highlights differences existing in the perception of SSS symptoms between a Thai and Polish population and demonstrates that the dermo-cosmetic cream effectively alleviates SSS symptoms and improves QoL in both ethnic groups.

目的:敏感性皮肤综合征(SSS)可影响各个民族的个体。然而,尽管人们认识到不同人群之间存在差异,但对不同人群的研究仍然有限。因此,我们研究了泰国和波兰受试者的SSS,评估了两种人群对皮肤化妆品的耐受性和疗效。方法:泰国参与者参与了一项为期28天的开放标签研究,而波兰受试者参加了一项为期56天的双盲随机研究,将该产品与对照霜进行比较。使用敏感皮肤负担(BoSS)问卷评估临床和功能体征以及生活质量(QoL)。结果:随着时间的推移,该产品在两组中耐受性良好,导致所有临床和功能体征显着改善(p)结论:该研究强调了泰国和波兰人群对SSS症状的感知存在差异,并证明真皮美容霜有效缓解了SSS症状并改善了两个民族的生活质量。
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引用次数: 0
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International Journal of Cosmetic Science
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