Multicenter methodology comparison of the FDA and ISO standard for measurement of in vitro UVA protection of sunscreen products.

In vitro standard methods are available and accepted worldwide to assess UVA protection of sunscreen products. Though, harmonisation of methods has made progress in the last decade, still two differing methods - one by FDA the other by ISO - are in use. In a multicentre study including 9 centres in Germany, 4 different commercial sunscreen products were assessed using both methods to discover their similarities and differences. UVA protection factor and Critical Wavelength were detected at various substrate type (sandblasted versus moulded PMMA plates), at different surface roughness of the plates as well as at different product application dose using two different irradiation spectra. Results: The strongest influence on UVA protection factor results from the surface roughness of the plates. Depending on the roughness (accepted range of 2 to 7 µm in the FDA method) a variability in the UVA protection factor of up to 25% was observed, while the much narrower definition of plate roughness by ISO (4.5 to 5.2 µm) had no relevant influence on the test results. Sandblasted plates in our assessment led to higher UVA protection factors and produced less scattered results compared to moulded plates. These differences were not pronounced. Application dose and spectra of the irradiation source were of negligible influence on UVA protection factor results for the investigated UV-filter combinations. The UVA protection factor which is the endpoint of the ISO method was found to be a parameter with a high potential to differentiate among different test products. The endpoint of the FDA method - the Critical Wavelength - was found to be an unambitious endpoint. Insensitivity to all described modifications of the method was observed. All investigated products performed similar and passed the Critical Wavelength criteria independent of method and parameters.

Influence of different cosmetic formulations on the human skin barrier.

The human skin barrier is an important part of the skin's intactness and its functionality is a precondition for healthy skin. Ingredients in cosmetic formulations, especially penetration enhancers, can influence this barrier function as they transport active agents into deeper skin layers. In this study different cosmetic formulations were tested by 60 healthy female volunteers over a period of 4 weeks. The skin hydration and barrier function before and during the application were measured. Significant changes in both parameters were determined. A negative influence on the barrier function by penetration enhancers could be observed, but it was also found that lamellar lipid structures (DermaMembranSysteme®, DMS®) are able to enhance the skin barrier. Both penetration enhancers as well as DMS can increase skin hydration.

Internet-based lay person rating of facial photographs to assess effects of a cleansing product and a decent cosmetic foundation on the attractiveness of female faces.

It is well established that decorative cosmetics can enhance female facial attractiveness. In this study, we investigated the effects of a cleanser and a decent foundation on attractiveness of female faces. Comparative rating of a set of facial photographs by a group of lay persons revealed that the cleansing product was significantly reducing the attractiveness of the stimulus persons. Treatment with the foundation increased the attractiveness of the female faces clearly. The authors conclude that even unobtrusive cosmetic treatments like cleansers and light foundations may cause relevant changes of the attractiveness of female faces.

An encapsulated fruit and vegetable juice concentrate increases skin microcirculation in healthy women.

BACKGROUND/AIM: Microcirculation in the dermis of the skin is important for nutrient delivery to this tissue. In this study, the effects of a micronutrient concentrate (Juice Plus+®; 'active group'), composed primarily of fruit and vegetable juice powder, on skin microcirculation and structure were compared to placebo. STUDY DESIGN/METHODS: This 12-week study had a monocentric, double-blind placebo and randomized controlled design with two treatment groups consisting of 26 healthy middle-aged women each. The 'oxygen to see' device was used to evaluate microcirculation. Skin density and thickness were measured using ultrasound. Measurements for skin hydration (Corneometer®), transepidermal water loss and serum analysis for carotenoids and α-tocopherol were also performed. RESULTS: By 12 weeks, microcirculation of the superficial plexus increased by 39%. Furthermore, skin hydration increased by 9% while skin thickness increased by 6% and skin density by 16% in the active group. In the placebo group, microcirculation decreased, and a slight increase in skin density was observed. CONCLUSION: Ingestion of a fruit- and vegetable-based concentrate increases microcirculation of the skin at 12 weeks of intervention and positively affects skin hydration, density and thickness.

Supplementation of flaxseed oil diminishes skin sensitivity and improves skin barrier function and condition.

BACKGROUND: Skin sensitivity is a common problem in the Western population correlated with changes of skin properties like skin barrier function, hydration and skin physiology. Skin properties can be modulated by dietary fatty acids (FA), especially poly-unsaturated FA. The present study was performed to evaluate the effect of daily supplementation with flaxseed oil and safflowerseed oil on healthy volunteers with sensitive skin. METHODS: The study was designed as a randomized, double-blind 12-week intervention with 2 female treatment groups (n = 13). Plasma FA profile, skin sensitivity, skin hydration, transepidermal water loss (TEWL) and skin surface were evaluated on day 0, week 6 and week 12. RESULTS: Supplementation with flaxseed oil led to significant decreases in sensitivity (after nicotinate irritation), TEWL, skin roughness and scaling, while smoothness and hydration were increased. Concomitantly, the ratio of n-6/n-3 FA in plasma decreased. Upon supplementation with safflowerseed oil, only a significant improvement in skin roughness and hydration was observed; however, the effects were less pronounced and determined at a later point in time than with flaxseed oil. The plasma n-6/n-3 FA ratio increased. CONCLUSION: The data provide evidence that daily intake of flaxseed oil modulates skin condition.

In vitro sun protection factor: still a challenge with no final answer.

In the past, several attempts have been made to develop in vitro methods for determining protection against UV radiation. To date however, there is no broadly accepted method. Various known and unknown parameters influence the transmission measurements of scattering films, such as the multifaceted compositions of sunscreens, the technical limitations of measurement devices as well as the difficulty to apply very thin films of sunscreen in a reproducible manner throughout different laboratories. In vitro data were measured in this multicenter study to compare possible methodologies and strategies for an in vitro approach to the sun protection factor (SPF). This publication will not present a final in vitro SPF test method, but it will point out which technical side effects may influence such a method. Influential factors such as the quality of spectrophotometer used, the amount of product applied, pretreatment of samples, time and temperature of equilibration, size of the measured surface, the application process or the calculation on the basis of standardized data are presented and discussed. Finally, a reduction of the standard deviations within single laboratories could be realized for in vitro SPF testing, but no improvement of the interlaboratory comparison was obtained. The development of a valid and reliable SPF in vitro test still remains a challenge, and further work is necessary to develop a satisfactory method.

Change in skin physiological parameters in space--report on and results of the first study on man.

Astronauts often show skin reactions in space. Systematic tests, e.g. with noninvasive skin physiological test methods, have not yet been done. In an interdisciplinary cooperation, a test series with skin physiological measurements was carried out before, during and after a long-term mission in the International Space Station. The hydration of the stratum corneum (Corneometer), transepidermal water loss (Tewameter), and the surface structure of the skin (SkinVisiometer) were measured. In order to record cutaneous states, the suction elasticity was measured (Cutometer), and an ultrasound measurement with 20 MHz (DermaScan) was also made. In addition, one measuring field of the two inner forearms was treated with a skin care emulsion. There were indications of a delayed epidermal proliferation of the cells, which would correspond to the clinical symptoms. Hydration and TEWL values are improved by respective skin care. On the cutaneous level, the elasticity measurements and the ultrasound picture showed results which correspond to a significant loss of elasticity of the skin. Further examinations are necessary to validate these preliminary results.

In vivo assessment of Ectoin: a randomized, vehicle-controlled clinical trial.

The aim of the study was to assess an Ectoin formulation with regard to the antiageing properties. The study was designed as a monocentric, randomized, double-blind application test, in order to ensure the compatibility and the efficacy of Ectoin in comparison to a vehicle emulsion. A total of 104 voluntary healthy female test subjects were included in the study. Moisturizing properties as well as other parameters of skin ageing, like skin surface structure and skin elasticity, were determined for treatment A (vehicle) and treatment B (with 2% Ectoin) versus an untreated control. Statistical evaluations according to the Wilcoxon rank-sum test indicate a general preference for the Ectoin treatment by the test subjects in both the application and the efficacy tests. None of the participating test subjects had any side effects throughout the study. In terms of antiageing properties, previous in vitro studies could be confirmed by this clinical trial, clarifying that the natural cell protection concept of Ectoin is transferable to skin care with manifold benefits.

Influence of applied quantity of sunscreen products on the sun protection factor--a multicenter study organized by the DGK Task Force Sun Protection.

It is often debated that the protection against solar-induced erythema under real conditions is dependent upon the amount of sunscreen applied. It is believed that when too little is applied a lower sun protection than indicated on the label will result. The aim of this study was to quantify this effect. In this multicenter study, the influence of three different amounts (0.5, 1.0, 2.0 mg/cm(2)) of three commercial sunscreen products in three reliable test centers was investigated according to the test protocol of The International Sun Protection Factor Test Method. The main result was a linear dependence of the SPF on the quantity applied. Taking into consideration the volunteer-specific variations, an exponential dependence of confidence interval of the in vivo SPF and amount applied was found. The highest amount applied (2.0 mg/cm(2)) was linked to the lowest confidence intervals. Thus, from the point of view of producing reliable and reproducible in vivo results under laboratory conditions, the recommendation of this multicenter study is an application quantity of 2.0 mg/cm(2).

In vitro assessment of water resistance of sun care products: a reproducible and optimized in vitro test method.

The aim of the study was to develop a simple reproducible and reliable in vitro water resistance (WR) method to assess the sun care products. This paper is the result of a scientific collaboration between seven different international industrial laboratories and testing institutes. The same group has already achieved an in vitro protocol for the sun protection factor (SPF) determination [1]. The in vitro WR of sunscreens was tested by applying the same principle as in vivo, which determines the percentage of retention of sunscreen products by assessing the SPF before and after water immersion. Special care was taken to study the parameters influencing the WR and the possibility to follow the kinetics of sunscreen retention during water immersion. The influence of different water qualities has been tested, and osmosed water (1-3 microS cm(-1)) was chosen for the main ring study. Measurement was carried out after 5, 20 and 40 min of immersion. Histograms of selected products demonstrate the percentage of WR at all measuring times and centres, and the regression coefficient to the in vivo determination was shown and statistical calculations clearly demonstrate the reproducibility of the results between the different evaluation centres. The presented method is a practical, convenient and relevant tool for WR screening of sun care and skin care products. It even has the potential to be the starting point for the replacement of the in vivo method in future.

Antioxidant supplements improve parameters related to skin structure in humans.

In the present study we investigated the influence of two different antioxidant supplements composed of carotenoids, vitamin E and selenium on parameters related to skin health and skin aging. Thirty-nine volunteers with healthy, normal skin of skin type 2 were divided into 3 groups (n = 13) and supplemented for a period of 12 weeks. Group 1 received a mixture of lycopene (3 mg/day), lutein (3 mg/day), beta-carotene (4.8 mg/day), alpha-tocopherol (10 mg/day) and selenium (75 microg/day). Group 2 was supplemented with a mixture of lycopene (6 mg/day), beta-carotene (4.8 mg/day), alpha-tocopherol (10 mg/day) and selenium (75 microg/day). Group 3 was the placebo control. Upon supplementation serum levels of selected carotenoids increased in both verum groups. Skin density and thickness were determined by ultrasound measurements. A significant increase for both parameters was determined in the verum groups. Roughness, scaling, smoothness and wrinkling of the skin were determined by Surface Evaluation of Living Skin (Visioscan). Roughness and scaling were improved by the supplementation with antioxidant micronutrients. In the placebo group no changes were found for any of the parameters.

Epithelial barrier function and atopic diathesis in rosacea and perioral dermatitis.

BACKGROUND: Rosacea and perioral dermatitis (PD) are common dermatoses, the aetiology and pathogenesis of which remain speculative. Objectives To investigate skin barrier function and features of atopy in both diseases. METHODS: We studied 75 patients with rosacea and 75 with PD. Transepidermal water loss (TEWL) was measured in three regions of the face (lateral chin, perinasal cheek, side of the nose) and the patients were assessed for atopy by clinical criteria, prick tests and specific IgE against a mixture of aeroallergens (CAP SX1). The control group consisted of 125 individuals with no history of rosacea, PD or active atopic disease. RESULTS: In patients with PD, TEWL was significantly increased (P < 0.001) at all measurement points in comparison with the rosacea and control groups. Significantly (P < 0.001) higher values were also found regarding history and clinical signs of an atopic diathesis, prick test reactivity and specific IgE against aeroallergens. CONCLUSIONS: PD is characterized by a skin barrier disorder of facial skin. It differs from rosacea in that it involves a significantly increased TEWL and features of an atopic diathesis. However, it remains disputed as to whether PD is an individual skin disease or a subtype of rosacea in atopic patients.

Comparison of sun protection factors determined by an in vivo and different in vitro methodologies: a study with 58 different commercially available sunscreen products.

An extensive study on the sun protection factors (SPF) of sun care products was carried out using the COLIPA (The European Cosmetic Toiletry and Perfumery Association) method, which relates to in vivo experiments. Furthermore, in vitro methods were tested with sunscreen formulations that were prepared as films on surface-roughened plates of polymethyl methacrylate (PMMA). One of the in vitro methods, i.e. using the sunscreen tester, has been recently developed, whereas the second has been defined by a pure spectroscopic approach, which is based on spectral transmission measurements of sunscreen films. Altogether 58 different sunscreen formulations, with manufacturer declared SPF values ranging from 4 to 60 and currently available on the European market, were investigated. The quality of correlations with results from the individual products based on the different in vitro methods versus the COLIPA values that were considered as generally accepted standard values was assessed. In this context, also variations because of sample preparation and spectral measurement were discussed. For sunscreen products with in vivo SPF values larger 25, the spectral transmittance within the UVA/UVB range is rapidly decreasing, which is experienced even for products with reduced amounts reaching 0.5 mg cm(-2) and still leading to unsatisfactory correlation of the spectroscopically derived SPF values versus the results from the alternative assays. Opposite to these small amounts, a sunscreen product spread of 2 mg cm(-2) is standard for the in vivo COLIPA method, whereas an area-normalized amount of 1 mg cm(-2) is currently routinely used for the sunscreen tester method. Furthermore, an overview of the individual product characteristics, such as their specific critical wavelengths and their UVA/UVB ratios is provided; both parameters can also be calculated from the spectral absorbances of the standardized sunscreen films.

Multicentre comparison of skin hydration in terms of physical-, physiological- and product-dependent parameters by the capacitive method (Corneometer CM 825).

A multicentre study for measuring skin hydration with 349 volunteers was carried out in six different laboratories. The purpose of the study was to investigate physical-, physiological- and product-dependent parameters of three test emulsions (base, base + moisturizer and base + moisturizer + lipids) in a double-blind study. A comparison between analogous and digital sensor technology of the Corneometer CM825 was examined. Here, a clear relationship between both sensor types could be highlighted. A vital point of the study was the division of the test subjects according to their skin type. To get more objective limits for three different skin types - very dry, dry and normal skin - visual expert evaluation, self-assessment and hydration measurements were analysed by means of statistical methods. The moisture-related skin types were determined as follows: very dry skin was characterized with corneometer units below 30, dry skin between 30 and 40 and normal skin higher than 40 a.u. (arbitrary units). The efficacy of the three test emulsions was examined in relation to the mentioned skin types. Analysing the measured data of all test centres, a clear dependency of skin physiology (skin type) and product efficacy became evident. The drier the skin, the higher the increase of hydration. The product performance of the three test emulsions compared to the untreated control resulted in a significant increase of skin hydration in all measuring centres. The evaluation of a product ranking showed a good differentiation between the basic emulsion and the two other products. An increase of efficacy by adding lipids could be observed in four of six centres. The important influence of the skin type of the volunteers on the degree of product performance, as demonstrated in this study, should be especially considered when drawing up guidelines for efficacy testing.

Dietary tomato paste protects against ultraviolet light-induced erythema in humans.

Carotenoids are efficient antioxidants capable of scavenging reactive oxygen species generated under conditions of photooxidative stress. It has been shown that supplementation with high doses of beta-carotene protects skin against UV-induced erythema. This study was designed to investigate whether intervention with a natural dietary source rich in lycopene protects against UV-induced erythema in humans. Tomato paste (40 g), providing approximately 16 mg/d of lycopene, was ingested with 10 g of olive oil over a period of 10 wk by 9 volunteers. Controls (n = 10) received olive oil only. Erythema was induced by illumination of dorsal skin (scapular region) with a solar simulator at the beginning of the study, after 4 wk and after 10 wk. Intensity of erythema was measured by chromatometry; the a-value was determined directly before and 24 h after irradiation. Serum carotenoid levels were measured by HPLC. At the beginning of the study, carotenoid levels did not differ between the two groups. Serum levels of lycopene increased in supplemented subjects; the other carotenoids did not change significantly, and no change in serum carotenoids was observed in the control group. At wk 10, dorsal erythema formation was 40% lower in the group that consumed tomato paste compared with controls (P = 0.02; Wilcoxon-Mann-Whitney test). No significant difference between groups was found at wk 4 of treatment. The data demonstrate that it is feasible to achieve protection against UV light-induced erythema by ingestion of a commonly consumed dietary source of lycopene.

In vitro testing to assess the UVA protection performance of sun care products.

The UVA protection delivered by sunscreens is an issue of increasing importance due to the increasing knowledge about UVA-induced skin damage. In Europe there is no officially accepted method available to determine the degree of UVA protection. Therefore, the objective of the present study was to design a protocol combining the merits of an in vitro model, which are simple and reproducible, with aspects known to be relevant from in vivo studies. The principle is: an UV-transparent support to which the test product is applied, a (pre)irradiation and a transmission measurement. Transpore(R) tape (standard support for SPF determinations) was found to be incompatible with many preparations on prolonged contact times. Roughened quartz was adopted as a suitable alternative. Transmission measurements on this support are not reliable with a layer of 2 mg cm(-2) (standard for SPF) due to detection limitations of spectrophotometers, hence a reduced layer of 0.75 mg cm(-2) was adopted. Overall, it is very difficult to apply products in a reproducible thin layer on appropriate substrates. As a consequence, absolute parameters derived from the transmission profile show relatively large dispersion, whereas relative parameters, such as critical wavelength lambda(c)[1] or UVA/UVB ratio are much less sensitive to unavoidable variations in layer thickness. An increase in deviations was observed when the samples were irradiated before measurement. It is crucial to control the output carefully (spectral distribution and even more importantly, irradiance and dose delivered) of the light source. By doing so and also taking into account the previous learning steps, a protocol was drafted and tested in a ringtest (four samples in six laboratories). The results are encouraging and show that if relative parameters (e.g. lambda(c), UVA/UVB ratio) are considered, the intra- as well as interlaboratory reproducibility is clearly better than can be obtained in vivo. In general, we describe a suitable method, which can be considered in any future official discussions about the methodology to determine UVA protection.

[Sarajevo, 1903]. / Sarajevo, 1903.

The current conflicts on the Balkans are used as an opportunity to call to mind the VIII. conference of the DDG in Sarajevo in 1903. For the first time, it then took place in a city which did not have a university and therefore no university clinic. Possible political but also dermato-venereological aspects concerning the choice of conference venue are discussed. Furthermore, highlights of the situation of the DDG in those days are presented and some central points regarding the professional topics of the conference and presentation are considered.

Carotenoids and carotenoids plus vitamin E protect against ultraviolet light-induced erythema in humans.

BACKGROUND: Carotenoids and tocopherols, known to be efficient antioxidants and capable of scavenging reactive oxygen species generated during photooxidative stress, may protect the skin from ultraviolet light-induced erythema. beta-Carotene is widely used as an oral sun protectant but studies on its protective effects are scarce. OBJECTIVE: The objective of this study was to investigate the protective effects of oral supplementation with carotenoids and a combination of carotenoids and vitamin E against the development of erythema in humans. DESIGN: A carotenoid supplement (25 mg total carotenoids/d) and a combination of the carotenoid supplement and vitamin E [335 mg (500 IU) RRR-alpha-tocopherol/d] were given for 12 wk to healthy volunteers. Erythema was induced by illumination with a blue-light solar simulator. Serum beta-carotene and alpha-tocopherol concentrations and skin carotenoid levels were assessed by HPLC and reflection photometry. RESULTS: Serum beta-carotene and alpha-tocopherol concentrations increased with supplementation. Erythema on dorsal skin (back) was significantly diminished (P < 0.01) after week 8, and erythema suppression was greater with the combination of carotenoids and vitamin E than with carotenoids alone. CONCLUSION: The antioxidants used in this study provided protection against erythema in humans and may be useful for diminishing sensitivity to ultraviolet light.