Skin colour assessment in safety testing of cosmetics. An overview

Synopsis
Few subjects are as problematical to dermatologists, cosmetologists and related experimenters involved in safety testing as the clinical assessment of skin colour. At the core of the problem is the word erythema, which does not communicate a sense for the nuance of red. In addition, light shades of red are not visible in dark-skinned people. Human assays aiming at evaluating the irritancy and allergic potential of cosmetics take advantage to use instrumental assessments of skin colour. However, there are pitfalls related to the complex biological aspects of the cutaneous reactivity, to the design of the in vivo assay, and to technical aspects bound to the principle of the measuring methods. Sound information can only be reached when these concerns are solved.
Résumé
Peu de sujets sont aussi problématiques pour les dermatologues, cosmétologues et autres expérimentateurs impliqués dans les tests de sûreté que l'évaluation clinique des couleurs cutanées. Au centre du problème est le mot érythème qui ne communique pas la notion des nuances de rouge. De plus, un érythème discret peut ne pas être visible chez des individus à la peau foncée. Les tests humains visant àévaluer les potentialités d'irritation et d'allergie aux cosmétiques bénéficient des évaluations instrumentales de la couleur cutanée. Cependant, il existe des pièges liés aux aspects biologiques complexes de la réactivité cutanée, au choix du test in vivo et à des aspects techniques en relation avec le principe du système de mesure. Une information adéquate ne peut être obtenue qu'après avoir résolu ces problèmes.     

Evaulation of irritation potential of surfactant mixtures

Irritation potential of sodium laureth sulfate (SLES) alone, and in combination with lauryl glucoside (LG), polysorbate 20 (PS) and cocoamidopropyl betaine (CAPB) was tested in 13 human subjects. Four main and six sub-formulations were prepared and evaluated. Formulations were applied to the forearm as a 24 h close patch study. Irritation was scored by two different methods using an in vivo clinical protocol based on visual scoring and on the stratum corneum capacitance measurement. Irritation was found to be dose dependent. At 2 mg/patch level ten subjects did not show any skin reaction. At 20 mg/patch level eleven subjects showed a broad range of skin irritation. The highest irritation was observed with the formula that contained SLES, LG, and cocamide DEA together. Among the sub-formulations, cocamide DEA showed the highest irritation grade. A statistically significant correlation was observed between visual, clinical and corneometer scores. It was concluded that the irritation potential of surfactants was related to the total surfactant concentration, application mode, and the thermodynamic activity of molecules in the solution as well as the chemical structure of the surfactant molecules.     

Protective effect evaluation of free radical scavengers on UVB induced human cutaneous erythema by skin reflectance spectrophotometry

This paper assesses the suitability of UVB induced skin erythema measured by reflectance spectrophotometry in humans as a model for differentiating topical efficacy of free radical scavengers. Two different formulations (aqueous gels and O/W emulsions) of each active compound (tocopherol, tocopherol acetate, superoxide dismutase (SOD), glutathione, ascorbyl palmitate) were tested on healthy human volunteers before and after skin exposure to UVB radiation. Skin erythema was monitored by calculating erythema index values from the skin spectral data obtained using a reflectance spectrophotometer. The free radical scavengers tested were not able to inhibit UVB induced skin erythema from both formulations when they were topically applied before UVB irradiation. Applying the free radical scavenger formulations after skin exposure to UVB radiation, glutathione and SOD showed the best ability in inhibiting the induced erythema (percentage inhibition 53.3 and 41.6%, respectively from gels). Tocopherol and tocopherol acetate inhibited UVB skin erythema by 27% while ascorbyl palmitate showed a poor efficacy. For all the active compounds tested, no significant difference was observed comparing the results obtained from gels to those from emulsions. Liposomal gel formulations containing the free radical scavengers which showed the best activity (SOD and glutathione) were prepared and topically applied after skin exposure to UVB radiation. SOD and glutathione liposomal formulations were more effective than the corresponding conventional gels. The proposed model, if validated by further studies, could be useful for differentiating the effectiveness of free radical scavengers in inhibiting photoaging due to long-term sunlight skin exposure.     

Methods for water resistance testing of sun protection products

Water resistance of sun protection products has been found to be best determined by the following methods: (1) Tests for determining UVL filter adherence to merino wool; this gives a rough value for orientation. Values in excess of 6% are suggestive of satisfactory adherence. (2) Tests for determining water resistance of sunscreen products on pig skin constitute a further essential step. Values in excess of 50% provide a realistic basis for tests in humans. In addition to filter adherence the product base, i.e. primarily the emulsifiers, are of special significance. Adequate results can be obtained with both W/O and O/W systems. Tests on volunteers are best done at the time of determining the sun protection factor, i.e. when simulating the events during a 2–3 h sunbath. Simulation should involve a single application of the test product in a pre-defined quantity and all activities conmmonly done in sunlight, e.g. swimming, as well as intermittent exercises to induce sweating. Values are considered as excellent, if 1 MED is not exceeded after 3 h exposure. Sun protection products with this characteristic qualify as adequate ‘all-day’ sunscreen for individuals with average sensitivity. Methodes pour mesurer la résistance à l'eau des produits anti-solaires     

Portable erythema meter and its application to use in human skin

In this study a compact, hand-held, solid state erythema meter using light emitting diodes is described. This device has been constructed and used to compare with visual assessments of ultraviolet radiation in human subjects. A statistically significant correlation was obtained between erythema index and visual assessment in 24 ultraviolet irradiated subjects. Furthermore, the effects of three aftersun treatments have also been assessed objectively using the meter and subjectively using visual assessments. The ultraviolet-irradiated areas were less red following treatment than the irradiated and untreated areas. The results obtained by the meter were similar to and statistically significant with those obtained by visual assessment.
It is concluded that widespread use of an erythema meter such as that described would greatly improve all cutaneous erythema assessments.     

一款含鲜奶面霜缓解皮肤红斑反应的功效评价研究

采用客观仪器评价方法对含鲜奶面霜单次使用后的缓解皮肤红斑反应的功效进行研究。选择30名18~55周岁有效受试者为研究对象,使用胶带粘贴及组胺刺激构建皮肤红斑反应模型,并采用无创仪器的方式检测并记录实验组、安慰剂组、阴性组及空白组受试者在组胺造模前、造模后、涂抹产品后30 min和60 min时的皮肤红斑指数EI值、皮肤敏感度值,采集皮肤图像,通过SPSS数据统计软件对实验结果进行统计分析。结果显示,含鲜奶面霜可以持续改善皮肤红斑指数EI值和皮肤敏感度,缓解由组胺导致的皮肤红晕反应,说明其具有一定的缓解皮肤红斑反应,改善皮肤敏感状态的功能。     

Mystery(n) Phenotypic Presentation in Europeans: Report of Three Further Novel Missense RNF213 Variants Leading to Severe Syndromic Forms of Moyamoya Angiopathy and Literature Review

Moyamoya angiopathy (MMA) is a rare cerebral vasculopathy in some cases occurring in children. Incidence is higher in East Asia, where the heterozygous p.Arg4810Lys variant in RNF213 (Mysterin) represents the major susceptibility factor. Rare variants in RNF213 have also been found in European MMA patients with incomplete penetrance and are today a recognized susceptibility factor for other cardiovascular disorders, from extracerebral artery stenosis to hypertension. By whole exome sequencing, we identified three rare and previously unreported missense variants of RNF213 in three children with early onset of bilateral MMA, and subsequently extended clinical and radiological investigations to their carrier relatives. Substitutions all involved highly conserved residues clustered in the C-terminal region of RNF213, mainly in the E3 ligase domain. Probands showed a de novo occurring variant, p.Phe4120Leu (family A), a maternally inherited heterozygous variant, p.Ser4118Cys (family B), and a novel heterozygous variant, p.Glu4867Lys, inherited from the mother, in whom it occurred de novo (family C). Patients from families A and C experienced transient hypertransaminasemia and stenosis of extracerebral arteries. Bilateral MMA was present in the proband’s carrier grandfather from family B. The proband from family C and her carrier mother both exhibited annular figurate erythema. Our data confirm that rare heterozygous variants in RNF213 cause MMA in Europeans as well as in East Asian populations, suggesting that substitutions close to positions 4118–4122 and 4867 of RNF213 could lead to a syndromic form of MMA showing elevated aminotransferases and extracerebral vascular involvement, with the possible association of peculiar skin manifestations.     

一种防敏理肤霜的人体功效研究

对一种防敏理肤霜进行了功效评价。选择20名18~50岁的健康女性,用质量分数为3%的十二烷基硫酸钠(SLS)溶液在双前臂内侧做封闭型斑贴试验24 h诱导产生红斑,使用受试产品防敏理肤霜,通过反复测量受试区域皮肤的经表皮失水率(TEWL值)、皮肤红色素含量以及对皮肤红斑进行评分,评估防敏理肤霜的舒缓修复效果。结果表明,受试产品防敏理肤霜能降低皮肤受到外界刺激因素后皮肤TEWL值,修复皮肤屏障功能,同时改善皮肤红斑情况,对受损皮肤具有一定的舒缓修复功效。     

Skin irritancy testing of toiletries and cosmetics on novel human models

A brief review of new techniques of assessing skin irritancy is presented. Some of the difficulties of assessing minor degrees of irritancy are discussed. Nouvelles méthodes pour l'évaluation sur l'être humain du pouvoir irritant des produits cosmetiques at d'hygiene