Performance of hybrid diffuse reflectance spectroscopy (HDRS-ISO 23698) methodology for assessment of sunscreen protection in the ALT-SPF Consortium validation study

IF 2.5 4区 医学 Q2 DERMATOLOGY
Eduardo Ruvolo, Curtis Cole, Mathias Rohr, Jay Silverman, Omid Yousefian, Jan Batzer, Nele Lange, Rita Touti, Florence Pouradier, Luciano Nogueira, Bertrand Colson
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Abstract

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.

Abstract Image

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
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。
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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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