Hybrid Diffuse Reflectance Spectroscopy: Non-Erythemal in vivo Testing of Sun Protection Factor

Abstract

Background/Aims: In order to define a label sun protection factor (SPF) of topically applied sunscreens, in vivo test methods like ISO 24444, FDA guideline, or the Australian standard are used worldwide. The basis of all these methods is provoking an erythemal skin reaction by UV irradiation to find the level of unprotected and protected minimal erythemal doses (MED). In vitro methods replacing the human skin by any kind of non-human material are still not available. Thus, offering the new hybrid diffuse reflectance spectroscopy (HDRS) technique that is able to stay on an in vivo level for SPF testing but meanwhile neglecting the UV-dose-related erythemal skin reaction is a perfect combination to take care of sun protection and any ethical concerns in SPF testing nowadays. Methods: HDRS is a combination of in vivo diffuse reflectance spectroscopy (DRS) measurements on the skin and in vitro transmission measurements of a sunscreen on a roughened polymethylmethacrylate plate. By this technique, the in vivo behavior of the investigated sunscreen on the skin is measured as well as the UVB absorption, which is still non-visible in the reflectance technique. In order to establish an alternative method for in vivo SPF testing, a huge number of sunscreens (80 samples) was measured by HDRS and compared to the worldwide accepted standard ISO 24444. The variety of sunscreens measured reflects a wide range of different types of formulations as well as a wide range of SPFs (5–120) to validate this new alternative SPF testing procedure. Results: The applied quantity of product as well as skin color dependencies of signal generation are shown to support any basic correlation of DRS signal generation and sun protection expectations. Far-reaching statistical data analyses show an excellent link of the new non-erythemally driven HDRS-SPF technique and ISO 24444 results. In the same way, HDRS-UVA-PF results can be correlated with UVA-PF values calculated from ISO 24443. Conclusion: Due to the elimination of any erythemal relevant UVB and UVA doses, absolutely no skin reaction occurs. Consequently there is no need to define a MED any more. For the first time an alternative way to SPF is shown without any ethical concerns of SPF testing in vivo and/or any restriction of SPF testing in vitro. Regardless of the type of formulation or the level of protection, an excellent correlation of SPF_HDRS and SPF₂₄₄₄₄ for sunscreen labeling could be found. By this new alternative non-erythemal technique, not only SPF values can be measured, but also UVA-PF values can be calculated with an excellent correlation to ISO 24443 from the same set of data. For the first time a robust alternative test method of SPF- and UVA-PF values is described, taking into account the interaction of sunscreen formulation and skin.

Development of the multispectral UV polarization reflectance imaging system (MUPRIS) for in situ monitoring of the UV protection efficacy of sunscreen on human skin

“…This system comprised a control unit, a lighting unit, and an image acquisition unit. This was a “dual spectral filtering system” that was similar to the double monochromatic system adopted in the HDRS . The UV spectral interference filter sets in the same wavelength range (310‐380 nm in 10‐nm steps) were mounted on both the light unit and the image acquisition unit.…”

“…Ruvolo et al proposed a new in vivo SPF assessment method that combined the human skin diffuse reflectance spectra and the in vitro transmittance spectra of sunscreen material . Rohr et al demonstrated that hybrid diffuse reflectance spectroscopy (HDRS) provided great SPF estimation accuracy for a huge variety of sunscreen materials ( R 2 = 0.973 for 80 materials in a wide formulation) . However, because these methods require contact examination of a particular skin site, in situ spatiotemporal evaluation is difficult.…”

“…On the other hand, because the invasive nature of the in vivo SPF method is troublesome, the development of an alternative approach had been studied both in vivo and in vitro. [19][20][21][22][23] Diffuse reflectance spectroscopy (DRS) techniques provide quantitative evaluation of in vivo SPF without any invasive process. [21][22][23] Reble et al proposed a method to estimate the in vivo SPF by distance-dependent DRS, and they applied it on five test materials that had an SPF range of 16-73.2.…”

“…[19][20][21][22][23] Diffuse reflectance spectroscopy (DRS) techniques provide quantitative evaluation of in vivo SPF without any invasive process. [21][22][23] Reble et al proposed a method to estimate the in vivo SPF by distance-dependent DRS, and they applied it on five test materials that had an SPF range of 16-73.2. 21 Ruvolo et al proposed a new in vivo SPF assessment method that combined the human skin diffuse reflectance spectra and the in vitro transmittance spectra of sunscreen material.…”

Quick and brief review: Comparison between different in vivo SPF determination methods

“…Also, as shown in Table , there are differences in the definitions of the labeled SPF classification between these protocols. Furthermore, in recent years, some new in vivo methods based on reflectance spectroscopy have been investigated to protect ethical concerns of UV‐induced damages on volunteers but all of them are not accepted as a new standard until now …”