Investigating the effect of the pH of foot care product formulations on pedal skin in diabetic and non-diabetic subjects.

OBJECTIVE: The use of skin care formulations with acidic pHs is seen as an effective method to maintain the acidic mantel of the skin; however, because the skin pH varies depending on the area of the body and as data are lacking for the skin pH of the feet, there was a need to examine whether this assumption holds true for skin care formulations designed for the foot. Thus, three foot creams formulated with a neutral, acidic or alkaline pH were compared with each other as well as to an untreated control group in order to analyse their impact on skin pH, hydration and general skin condition. METHODS: An exploratory clinical investigation with 60 enrolled subjects, half of whom had a diagnosis of diabetes (type 1 or type 2), was undertaken. The investigation followed a randomized, double-blind, balanced incomplete block design (BIBD) including intra-individual comparison (before and after treatment). Evaluations of skin pH and hydration were carried out using a pH meter and a Corneometer respectively. Objective evaluation of skin condition for efficacy assessment was performed by a trained grader. For tolerability evaluation, objective and subjective dermatological assessments were performed. RESULTS: At the end of the treatment period, the skin pH was largely unchanged at five out of six of the test areas, with the mean value for each treatment group using test products showing similar fluctuations as the untreated control group. Furthermore, the skin condition parameters studied all improved by a comparable magnitude for each of the treatment groups using the test products, whereas the untreated control group experienced a worsening of the skin condition parameters. CONCLUSIONS: The results of this investigation suggest that where the skin of the foot is concerned, the pH of skin care formulations has no (physiologically) relevant influence on the skin's pH in either diabetic or non-diabetic subjects. Furthermore, the expectation that acidic formulations would be more beneficial for the skin's condition was not found to hold true for the skin of the foot, as no significant difference was observed between the performance of the three test products investigated in this study.

OBJECTIF: L'utilisation de formulations de soins cutanés à pH acide est considérée comme une méthode efficace pour préserver le manteau acide de la peau. Cependant, comme le pH de la peau varie en fonction de la zone corporelle et comme les données manquent concernant le pH de la peau des pieds, il était nécessaire d'examiner si cette hypothèse est vraie pour les formulations de soins cutanés conçues pour le pied. Ainsi, 3 crèmes pour les pieds à pH neutre, acide ou alcalin ont été comparées entre elles, ainsi qu'à un groupe témoin non traité, afin d'analyser leur impact sur le pH de la peau, l'hydratation et l'état général de la peau. MÉTHODES: Une étude clinique exploratoire a été menée sur 60 sujets inclus, dont la moitié avait reçu un diagnostic de diabète (de type 1 ou de type 2). L'étude a suivi une conception randomisée, en double aveugle, en blocs incomplets équilibrés (balanced incomplete block design, BIBD), comprenant une comparaison intra-individuelle (avant et après le traitement). Les évaluations du pH de la peau et de l'hydratation ont été réalisées à l'aide d'un pH-mètre et d'un cornéomètre, respectivement. Une évaluation objective de l'état de la peau a été réalisée par un évaluateur formé en ce qui concerne l'évaluation de l'efficacité. Pour l'évaluation de la tolérance, des évaluations dermatologiques objectives et subjectives ont été réalisées. RÉSULTATS: À la fin de la période de traitement, le pH de la peau était en grande partie inchangé dans 5 des 6 zones de test, la valeur moyenne pour chaque groupe de traitement utilisant des produits testés montrant des fluctuations similaires à celles du groupe témoin non traité. En outre, les paramètres de l'état de la peau étudiés se sont tous améliorés dans une mesure comparable pour chacun des groupes de traitement utilisant les produits à l'étude, tandis que le groupe témoin non traité a présenté une aggravation des paramètres de l'état de la peau. CONCLUSIONS: Les résultats de cette étude indiquent qu'en ce qui concerne la peau du pied, le pH des formulations de soins de la peau n'a pas d'influence (physiologiquement) pertinente sur le pH de la peau chez les sujets diabétiques ou non diabétiques. En outre, l'attente selon laquelle des formulations acides seraient plus bénéfiques pour l'état de la peau n'a pas été confirmée pour la peau du pied, car aucune différence significative n'a été observée entre les performances des 3 produits testés étudiés dans cette étude.

A new dexpanthenol-containing liquid cleanser for atopic-prone skin: Results from two prospective clinical studies evaluating cutaneous tolerability, moisturization potential, and effects on barrier function.

BACKGROUND: Gentle cleansing of the skin without further compromising its barrier function and moisture content and being simultaneously devoid of adverse effects on the skin microbiome are important features of body cleansers for atopic-prone skin sufferers. For this population, a new dexpanthenol-containing liquid cleanser (DCLC) was developed. METHODS: Two prospective 4-week studies have been conducted. Study 1 investigated the effect of once-daily DCLC on stratum corneum (SC) hydration, transepidermal water loss (TEWL), skin pH, and skin microbiome (all on the volar forearm) in adult subjects with dry skin (N = 44). Study 2 explored the cutaneous tolerability of DCLC and its effect on the microbiome biodiversity of the volar forearm skin in infants/children with atopic-prone skin (N = 33, aged 6 months to 6 years). In the latter study, DCLC was applied 2-3 days/week in combination with an emollient applied at least twice daily. RESULTS: In Study 1, on Day 29, the mean change in skin surface capacitance from baseline was significantly greater in the forearm test area treated with DCLC than in the contralateral test area (control) treated with water only (5.16 vs. 3.65 a.u.; p = 0.011), suggesting long-term SC hydration. DCLC use was not associated with changes in TEWL, skin pH, or microbiome biodiversity if compared to control. In Study 2, the 4-week use of DCLC in combination with an emollient was well tolerated according to pediatrician skin assessment, and no flare-ups were recorded. The microbiome biodiversity did not shift during the study. CONCLUSION: These findings support the use of DCLC in subjects with atopic-prone skin.

Pilot study to determine differences in breath odour between cigarette and e-cigarette consumers.

Cigarette smoke is known to influence breath odour, but the effect of e-cigarettes is unknown. In this pilot study, we aimed to determine differences in breath odour between cigarette smokers (CSs) and e-cigarette consumers (ECs) in 33 healthy subjects: 11 CSs, 11 ECs and 11 non-smokers (NSs). Breath was sampled at baseline and following product use (CSs and ECs) or a waiting period (NSs) by eight trained odour judges using a six-point smoke intensity scale and a nine-point hedonic scale. We observed a statistically significant difference between CSs and ECs. Smoke intensity values were significantly higher in CSs than ECs and NSs, which were comparable both at baseline and after product use. In addition, hedonic values for CSs were significantly lower than both NSs and ECs after product use. These acute results indicate that cigarette and e-cigarette use results in significantly different breath. ECs breath has a reduced smoke odour and more pleasant aroma than CSs, and is comparable to NSs. This suggests there may be cosmetic benefits for CSs who quit smoking or switch to exclusive use of ECs. Further studies are required to understand the long-term effects of e-cigarette use on breath odour.

Efficacy and tolerability of a detergent and care component for rosacea patients: A split-face, vehicle-controlled, randomized trial.

BACKGROUND: The treatment of facial erythema and subjective symptoms of rosacea patients remains challenging in clinical practice. Cosmeceuticals, care components containing active ingredients such as phytochemicals, play a growing role in treatment plans. However, well-designed studies on their efficacy and limitations are widely missing. OBJECTIVE: A foam and a cream for rosacea patients were assessed based on objective and subjective methodology. The tolerability of skin and eyes was evaluated. METHODS: A randomized, double-blinded, split-face, and vehicle-controlled trial was conducted. At baseline and after four weeks of product use, dermatological and ophthalmological investigations were performed, employing image analysis of facial erythema, clinical assessments, and questionnaires. RESULTS: The patient cohort comprised 33 females with persistent facial erythema due to rosacea. No significant differences were found between the vehicle and the verum. According to the analysis of facial erythema, a "less pronounced" or "much less pronounced" appearance was seen in two thirds of patients comparing V1 to V0. Especially, the dryness of the skin improved by the use of the vehicle and the verum. Adverse subjective skin sensations decreased by 61.3% for the verum side and by 58.6% for the vehicle side. Subjective and objective analysis of ocular manifestation differed, with subjective manifestations reported more frequently, thus highlighting underdiagnosis of ocular rosacea. CONCLUSIONS: As no clear differences between the verum and the vehicle were found, an optimal skin care regime itself seems to have a superior effect in the relief of facial erythema and foremost of subjective symptoms, rather than certain active ingredients.

A novel clinical method to measure skin staining reveals activation of skin damage pathways by cigarette smoke.

BACKGROUND: Long-term use of cigarettes can result in localised staining and aging of smokers' skin. The use of tobacco heating products (THPs) and electronic cigarettes (ECs) has grown on a global scale; however, the long-term effect of these products' aerosols on consumers' skin is unknown. This pilot clinical study aimed to determine whether THP or EC aerosol exposure results in skin staining or activation of biomarkers associated with oxidative stress. MATERIALS AND METHODS: Eight areas were identified on the backs of 10 subjects. Two areas were used for air control, and two areas exposed to 32-puffs of cigarette smoke (CS), THP or EC aerosols, which were delivered to the skin using a 3-cm diameter exposure chamber and smoke engine. Skin colour was measured using a Chromameter. Squalene (SQ), SQ monohydroperoxide (SQOOH) and malondialdehyde (MDA) levels were measured in sebum samples by mass spectrometry and catalase colorimetry. RESULTS: CS exposure significantly increased skin staining, SQOOH and MDA levels and SQOOH/SQ ratio. THP and EC values were significantly lower than CS; EC values being comparable to air control. THP values were comparable to EC and air control at all endpoints, apart from skin staining. SQ and catalase levels did not change with exposure. CONCLUSIONS: CS stained skin and activated pathways known to be associated with skin damage. THPs and ECs produced significantly lower values, suggesting they could offer hygiene and cosmetic benefits for consumers who switch exclusively from smoking cigarettes. Further studies are required to assess longer-term effects of ECs and THPs on skin function.

Targeted dry skin treatment using a multifunctional topical moisturizer.

OBJECTIVE: The development of dry skin is a complex process, with a wide variety of factors each playing different roles in its evolution. Given this, it is important when designing a formulation to tackle dry skin that these varied aspects of skin behaviour are addressed. Presented here are the results of a 3-week moisturization study carried out on dry legs. A wide range of traditional and more recently developed biophysical measurement methods have been combined with visual assessment of skin condition to enable multiple aspects of skin function to be determined. The observed changes in the skin are discussed in terms of the ingredients used in the moisturizing formulation. METHODS: A range of novel and traditional skin assessment methods and techniques were used to assess the effects of an oil in water-based moisturizing product compared to an untreated site during a 3-week in vivo study on dry lower leg skin. RESULTS: Statistically significant improvements were observed in a range of skin parameters as a result of product usage. Skin hydration assessed using Corneometer®, Epsilon® and visual dry skin grading all increased after 3 weeks of use. Skin barrier function measured using transepidermal water loss also improved. Levels of cholesterol, free fatty acids and Ceramide NH increased, as well as the average length of the stratum corneum (SC) lipid lamella bilayers, and the ratio of lipid to protein increased (measured using Lipbarvis® and in vivo Confocal Raman Spectroscopy). Increases in the levels of Ceramide EOS and NP were also observed, along with an improvement in corneocyte maturity, although these were not statistically significant. CONCLUSIONS: Using a variety of traditional and novel skin assessment techniques, a wide range of factors associated with the evolution of dry skin have been assessed upon treatment with a new topical moisturizer. Product usage resulted in significant improvements to skin hydration and barrier function, the levels and morphology of SC barrier lipids, and overall epidermal differentiation. As a result there was a significant reduction in the characteristics associated with the development of dry skin after use of the test product.

OBJECTIF: le développement de la sécheresse cutanée est un processus complexe, une grande variété de facteurs jouant chacun des rôles différents dans son évolution. De ce fait, il est important d'aborder ces différents aspects du comportement de la peau lors de la conception d'une formulation pour lutter contre la sécheresse cutanée. Les résultats d'une étude de 3 semaines sur l'hydratation des jambes sèches sont présentés ci-dessous. Un large éventail de méthodes de mesure biophysiques traditionnelles et plus récemment développées ont été combinées à une évaluation visuelle de l'état de la peau pour permettre de déterminer de multiples aspects de la fonction cutanée. Les changements observés sur la peau sont abordés en termes des ingrédients utilisés dans la formulation hydratante. MÉTHODES: une série de méthodes et de techniques nouvelles et traditionnelles d'évaluation de la peau ont été utilisées pour évaluer les effets d'un produit hydratant à base d'émulsion huile dans eau par comparaison à un site non traité au cours d'une étude in vivo de 3 semaines sur la peau sèche de la partie inférieure des jambes. RÉSULTATS: des améliorations statistiquement significatives ont été observées au niveau d'une gamme de paramètres cutanés suite à l'utilisation du produit. L'hydratation cutanée évaluée à l'aide de Corneometer®, Epsilon® et de la cotation visuelle de la sécheresse cutanée s'est améliorée selon toutes ces méthodes après 3 semaines d'utilisation. La fonction de barrière cutanée mesurée d'après la perte d'eau transépidermique s'est également améliorée. Les taux de cholestérol, d'acides gras libres et de céramides NH ont augmenté, ainsi que la longueur moyenne des bicouches des lamelles lipidiques de la couche cornée (CC), et il en a été de même pour le rapport lipide/protéine (mesuré à l'aide du Lipbarvis® et de la spectroscopie confocale de Raman in vivo). Des augmentations des taux de céramides EOS et NP ont également été observées, ainsi qu'une amélioration de la maturité des cornéocytes, bien qu'elles n'aient pas été statistiquement significatives. CONCLUSION: à l'aide d'une gamme de techniques d'évaluation de la peau traditionnelles et nouvelles, un large éventail de facteurs associés à l'évolution de la sécheresse cutanée a été évalué lors du traitement avec un nouveau produit hydratant topique. L'utilisation du produit a entraîné une amélioration significative de l'hydratation et de la fonction de barrière de la peau, des taux et de la morphologie des lipides de la barrière SC , et de la différenciation épidermique globale. Cela a entraîné une amélioration significative des facteurs associés au développement de la sécheresse cutanée.

Influence of climatic conditions on antiperspirant efficacy determined at different test areas.

BACKGROUND: The efficacy of antiperspirants is a current topic among the developers of cosmetic products. According to the Food and Drug Administration (FDA) for the US market, efficacy testing performed in the axilla of human volunteers is mandatory. Another method is yet available, which enables comparison of more than one antiperspirant formula in a single study by performing the test on the backs of volunteers. However, how reproducible are these methods, comparing between the back and axilla? Do they differ as a result of seasonal variation? Is a correlation between the results of the two methods possible? METHODS: To answer these questions, the antiperspirant efficacy of aluminium chlorohydrate (ACH) aqueous solutions was investigated in the axilla and on the backs of volunteers, in four separate clinical studies covering cold and warm seasons. Four days of product application were followed by thermal sweat induction on the fifth day, using a sauna. The amount of sweat recovered by weighing cotton pads before and after sweat induction was used to calculate sweat reduction. Testing in the axilla and on the back was performed on the same volunteers simultaneously to achieve the best comparable data. For this reason, the FDA guideline was slightly modified to thermal stimulation in a sauna instead of in a hot room. RESULTS: Increasing concentrations of ACH in aqueous solutions on the backs of volunteers showed a saturation for 8% ACH with a sweat reduction of approximately 50%. The antiperspirant efficacy of solutions containing 4%, 8% or 12% ACH was repeatedly found at the same levels, when tested on the backs during summer, autumn and winter time. Axilla tests, with an 8% ACH aqueous solution, showed strongly varying results for summer and winter time, represented by sweat reduction values of -2% to 25%. As an assumption, these high variations might result from reduced gel formation in cold seasons due to low humidity in the axillae during the application phase. On the back, this effect was avoided by applying occlusive foils after product application. To gain further insight, a study, during which summer conditions were artificially simulated by thermal stimulation during the application phase, again showed decreased antiperspirant efficacy in the axilla for winter conditions with sweat reduction values of 2%, compared with 25% under simulated summer conditions. CONCLUSION: These strongly varying values of sweat reduction in the axilla under summer and winter conditions make comparisons between antiperspirant products difficult and a statement about correlation between the two test sites back and axilla impossible. A standardization of the application phase, comparable to the simulated summer conditions described here, could be a solution to reduce the high variation of results in the axilla. Consequently, testing on the back is not only a more cost-effective method to investigate the antiperspirant efficacy of more than one formulation, but a reproducible method more independent of climatic influences during test implementation than the axilla test method. It could, therefore, be regarded as the method of choice for discriminating antiperspirant efficacy between several products during development of new antiperspirant formulations.

Non-invasive evaluation techniques to quantify the efficacy of cosmetic anti-cellulite products.

BACKGROUND: The majority of women suffer from the unattractive sight of dimpling skin on the thighs and buttocks, globally known as cellulite. Cellulite can be regarded as the most investigated non-disease, because, from the cosmetic viewpoint, most women desire a reduction in cellulite severity. Despite investigations made, cellulite is still not well understood at the cellular level, which leads to controversy regarding the investigative methods for cellulite reduction as well as the development of products to treat cellulite skin. OBJECTIVE: The aim of our work was to improve the set up of macrophotography for making images of dimpled skin and to automatize image analysis of 20 MHz ultrasound imaging - these two methods being just two of a variety of available methods for investigating cellulite skin. METHODS: Macrophotography was standardized on the aspects of volunteer's positioning, skin illumination, background used, and camera position. It was performed before, during and after a 3-month-treatment of a cosmetic product. Scoring assessments of the generated images were made by the volunteers themselves as well as by six trained experts. Ultrasound imaging was performed at the baseline visit in order to correlate the newly developed analysis with the visually rated cellulite score. A second study is also presented showing a variety of parameters that can be used for cosmetic testing of cellulite products: skin firmness, blood circulation and circumferential thigh measurements. RESULTS: Standardization of macrophotography minimized differences in image features between assessment times, therefore, enabling follow-up rating assessments of the images. A custom-made rating program simplified the scoring procedure by presenting images as blind and randomized, and by implementing computer-based analysis using an online rating scale. Volunteers and experts scored significant improvement of skin appearance over the course of a 3-month cosmetic treatment. Image analysis of ultrasound imaging was automatized, and a modification of the commonly known roughness parameter Ra was implemented to characterize cellulite severity. Comparison with the visually rated cellulite score showed an existing correlation between the score and the modified parameter Ra(m). Further parameters investigated in an exemplary study, as mentioned above, demonstrated a significant improvement of skin appearance after treatment with a cosmetic product. CONCLUSIONS: Macrophotography and ultrasound imaging can be regarded as important tools for determining and quantifying the aspects of cellulite. With a gold standard missing for investigating cellulite severity, these two methods may not determine cellulite at the cellular level, but they do characterize the skin appearance so typical for cellulite. Combined with a variety of other methods, macrophotography and ultrasound imaging can very well define cellulite-reducing efficacy from the cosmetic point of view.