Influence of Applied Quantity of Sunscreen Products on the Sun Protection Factor – A Multicenter Study Organized by the DGK Task Force Sun Protection

Bimczok, R.; Gers‐Barlag, H.; Mundt, Claudia; Klette, E.; Bielfeldt, S.; Rudolph, T.; Pflücker, F.; Heinrich, Ulrike; Tronnier, H; Johncock, W.; Klebon, B.; Westenfelder, H.; Flöβer-Müller, H.; Jenni, Klaus; Kockott, D.; Lademann, Jürgen; Herzog, Bernd; Rohr, M.

doi:10.1159/000096173

Cited by 74 publications

(77 citation statements)

References 9 publications

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“…In all cases a monoexponential fit can be calculated to describe the link of SPF HDRS and amount of product applied. Corresponding SPF 24444 results of these 3 test products are SPF 32, SPF 41 and SPF 53, which are exactly those values measured at 2.0 mg/cm 2 applied [30]. Following these results an excellent link of SPF HDRS and SPF 24444 is found in a first approach without the need of any further data treatment.…”

Section: Resultssupporting

confidence: 70%

“…For the first time this combination offers an alternative in vivo driven technique to SPF without any ethical concerns, incorporating possible sunscreen-skin interactions influencing the efficacy of different vehicles [16, 17]. Measuring SPF in vivo is always a challenge [11, 30]. Based on ISO 24444 a wide range of technical and practical parameters have to be considered and fulfilled in total.…”

Section: Discussionmentioning

confidence: 99%

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

Rohr

Ernst

Schräder³

2018

Skin Pharmacol Physiol

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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.

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Section: Resultssupporting

confidence: 70%

Section: Discussionmentioning

confidence: 99%

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

Rohr

Ernst

Schräder³

2018

Skin Pharmacol Physiol

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“…10,.32 The interference of the applied amount in the level of protection offered by sunscreens was evaluated by different authors. 36,38,42,43 The findings of these studies, particularly with regard to the evaluation of the interference pattern of the amount applied in determining the SPF value, are contradictory.…”

mentioning

confidence: 99%

Fator de proteção solar: significado e controvérsias

Schalka

Reis

2011

An. Bras. Dermatol.

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Abstract:The Sun Protection Factor (SPF) is the most important data to quantify the effectiveness of a sunscreen, being universally accepted. The method is based on determining the minimum erythematous dose (MED), defined as the smallest amount of energy required for triggering the erythema, in areas of protected and unprotected skin. The SPF value is then calculated as the ratio between the MED of protected and unprotected skin. The first publication of a method for determining the SPF was presented in 1978 by the U.S. FDA agency, followed by other publications of FDA and other international regulatory agencies. Although considered the reference method for quantification of sunscreen efficacy of topical products, there are controversies in literature about the method for determining the SPF and the implications of the real conditions of use in the protection achieved in practice by users. Keywords: Dermatology; Solar radiation; Sunscreening agents Resumo: O Fator de Proteção Solar (FPS) é o principal dado para quantificação da eficácia fotoprotetora de um filtro solar, sendo universalmente aceito. Seu método é baseado na determinação da Dose Eritematosa Mínima (DEM), definida como sendo a menor quantidade de energia necessária para o desencadeamento de eritema, em áreas de pele protegidas e não protegidas pelo produto em estudo. O valor do FPS é, então, calculado como a razão numérica entre a DEM da pele protegida e a da pele não protegida. A primeira publicação demonstrando um método para determinação do valor do FPS foi apresentada em 1978 pela agência norte-americana FDA, seguida por outras publicações do próprio FDA e de outras agências regulatórias internacionais. Apesar de ser considerado o método referência para quantificação da eficácia fotoprotetora de produtos tópicos, existem controvérsias na literatura acerca do método para determinação do FPS e sobre as implicações das reais condições de uso na proteção atingida na prática pelos usuários.

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“…Ambitious research work is being undertaken, in order to optimize the product-defining characteristics of sunscreen filters and sunscreen formulations. Under real-life conditions, however, the effectiveness of sunscreens is often limited due to an insufficient quantity being applied [8,9,10], inhomogeneous filter distribution [11,12,13] and filter abrasion [14,15,16]. Whereas application habits such as quantity and frequency of sunscreen use can be changed intentionally, limitations in product efficacy, due to skin morphology and condition, are more difficult to be overcome.…”

Section: Introductionmentioning

confidence: 99%

Gain or Loss? Sunscreen Efficiency after Cosmetic Pretreatment of the Skin

Kluschke

Weigmann²,

Schanzer

et al. 2013

Skin Pharmacol Physiol

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Sunscreens are a key pillar of the multimodal protection strategy against short- and long-term impacts of intermittent and continuous UV exposure. Hitherto, an unanswered part of current scientific discourse is the question whether a cosmetic pretreatment has an impact on distribution and adhesiveness of sunscreens on the skin and therefore affects UV protection. In order to evaluate the homogeneity of sunscreen filter distribution, water resistance as a parameter of adhesiveness and effective UV protection of sunscreens after a pretreatment with cream or lotion was investigated in 18 volunteers who were examined before and after swimming, using the established combination of the tape stripping procedure and UV/VIS spectroscopy. It was shown that a cosmetic skin pretreatment affects neither filter homogeneity nor effective UV protection prior to water contact. However, compared to nonpretreated skin, a considerable loss of water resistance is caused. Therefore, using a cream or lotion before application of sunscreens is not to be recommended.

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Influence of Applied Quantity of Sunscreen Products on the Sun Protection Factor – A Multicenter Study Organized by the DGK Task Force Sun Protection

Cited by 74 publications

References 9 publications

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

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

Fator de proteção solar: significado e controvérsias

Gain or Loss? Sunscreen Efficiency after Cosmetic Pretreatment of the Skin

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