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.

A real-world evidence study evaluating consumer experience of Supradyn Recharge or Supradyn Magnesium and Potassium during demanding periods.

Background: Challenging periods and/or mild micronutrient deficiencies may result in a lack of energy and general fatigue, frequently occurring in the general population. Supradyn Recharge and Supradyn Magnesium and Potassium (Mg/K) are multimineral/vitamin supplements formulated to ensure adequate daily intake of micronutrients. We conducted an observational study addressing consumption behaviour, reasons for intake, frequency of intake, and consumer experiences, satisfaction and characteristics under real-life conditions. Methods: This was a retrospective, observational study carried out with two computer-aided web quantitative interviews. Results: A total of 606 respondents (almost equally split between men and women; median age 40 years) completed the questionnaires. The majority indicated having a family, a job and a good level of education; they stated to be long-time and daily users, reporting an average daily intake of 6 days a week. More than 90% of consumers claimed they were satisfied, would use the products again and recommend them; over two-thirds felt the value for money was good. Supradyn Recharge has been mainly used to support lifestyle change and mental resilience, seasonal changes, and post-illness recovery. Supradyn Mg/K has been used to sustain or regain energy levels during hot weather or physical activity and as a support against stress. Users claimed a positive impact on quality of life. Conclusion: Overall, the perception of benefit by consumers was extremely positive as reflected in their consumption behaviour, the majority of whom stated to be long-time users and daily consumers, with an average daily intake of 6 days for both products. These data complement and add up to the results of Supradyn clinical trials.

Evaluation of a 5% dexpanthenol-containing ointment for the treatment of infant irritant diaper dermatitis through the lens of the caregiver-A real-world data observational study.

Background and Aims: Irritant diaper dermatitis (IDD) is very common in infants and usually managed by the caregiver. Dexpanthenol-containing ointment (DCO) is a decades-long established product that has demonstrated efficacy and tolerability in the treatment and prevention of infant IDD in controlled clinical settings. The aim of this study was to evaluate the effectiveness of DCO in the treatment of infant IDD from the perspective of the caregiver by collecting data not explored in clinical trials, such as infant quality of life and the speed of action. Methods: A retrospective observational real-world data (RWD) study was conducted with French adult caregivers who had used a DCO to treat IDD in their infants within the past 6 months and consented to participate to the study completed a web-based survey answering questions regarding the severity of their infants' symptoms (intensity/extent of redness and discomfort, rated using Likert scales) before and after DCO application. The speed of onset of symptom relief and product acceptability were also collected. Results: A total of 500 caregivers of 564 infants completed the survey. Of these, 80% reported that DCO visibly treats IDD. In terms of speed of action, 83% declared that the first signs of symptom relief appeared after 1 day of application and 78% reported full symptom resolution within 2 days of application. Additionally, ≥77% of caregivers agreed that DCO provided overnight relief from the discomfort caused by IDD and reduced sleep disturbance in their children. Finally, 85% of caregivers declared being satisfied with the product overall and considered the product pleasant to use. Conclusion: This evidence from caregivers' experience confirms that DCO can be considered an adequate medication to self-manage IDD episode as it provides rapid relief of the signs and symptoms of inflammation, while by being pleasant to be use.

A real-world evidence study evaluating Geffer effervescent granules for the symptomatic relief of digestive symptoms.

Objectives: Geffer effervescent granules (active ingredients: metoclopramide, dimethicone, and sodium bicarbonate) is an established over-the-counter medication available in Italy for the symptomatic treatment of hyperacidity (pain and/or heartburn) when accompanied by slowing of gastric transit, nausea, aerophagia, and bloating, all symptoms that can occur in functional dyspepsia and can negatively impact individuals' quality of life. The aim of this observational study was to explore the perceived benefits of, and consumer experience with, Geffer effervescent granules used for the symptomatic treatment of digestive disorders suggestive of functional dyspepsia under real-life conditions in Italy. Methods: Adults (aged 35-65 years) experiencing symptoms suggestive of functional dyspepsia/indigestion at least once a month and who had used Geffer effervescent granules within the previous 6 months completed an online questionnaire eliciting information on symptom relief (speed of onset and duration) and quality of life. Results: Geffer effervescent granules provided rapid onset of symptom relief, with 21% of respondents perceiving an effect within 10 min and 88% reporting an improvement in overall symptoms within 30 min. A similarly rapid onset of complete resolution of gastric pain/cramps, acidity, bloating, nausea, and bothersome fullness symptoms was reported by 65%-83% of respondents; 50%-59% of respondents were free from such symptoms for more than 3 h or until the next meal. Most participants (92%) reported that their quality of life improved when taking Geffer effervescent granules to treat hyperacidity symptoms. Overall, 95% of the respondents were satisfied with the effectiveness of Geffer effervescent granules on overall symptom relief. Conclusions: In Italian consumers with digestive disorders likely due to functional dyspepsia, Geffer effervescent granules was associated with rapid, complete, and durable relief of symptoms of gastric pain/cramps, acidity, bloating, nausea, and bothersome fullness; an improvement in quality of life; and a high level of consumer satisfaction.

Vulvovaginal candidiasis: A real-world evidence study of the perceived benefits of Canesten®.

Objectives: Vulvovaginal candidiasis is common in women, causing discomfort and negatively impacting quality of life. Canesten® is an established over-the-counter brand. Its clotrimazole/fluconazole-based products, available in a variety of different formulations, have demonstrated efficacy and safety in the treatment of women with thrush/vaginal yeast infection in randomized trials. This real-world evidence study, conducted in the United Kingdom and Canada, aimed to provide consumer-important information on the benefits of Canesten, collecting retrospective information from consumers about their recent experience with the product. Methods: Eligible participants were female, aged 18-60 years, and had experienced at least one episode of vaginal thrush (United Kingdom)/vaginal yeast infection (Canada) during the previous 6 months for which they had used at least one of the six Canesten products. Participants completed an online questionnaire eliciting information on the speed of onset of symptom relief, impact on quality of life, and product attributes/satisfaction. Results: Over 90% of respondents reported improvements in symptoms and quality of life after starting treatment with a Canesten product. Improvements in symptoms within 4 h of the first time of use were perceived by 42% of consumers; 76%-88% reported symptomatic relief within 1 day. The perceived general speed of onset of symptomatic relief with a Canesten oral product (1-2 days) was slightly longer than that with a Canesten topical/intra-vaginal product (⩽1 day). Most users of Canesten single (90%) and dual product treatments (95%) reported that the products started to work from the first application. Women experiencing both internal and external symptoms of thrush/vaginal yeast infection reported Canesten dual product formulations to provide faster symptomatic relief than single product treatments. Over 90% of respondents were satisfied with their use of a Canesten product. Conclusion: Canesten was found by consumers to offer rapid relief of the symptoms of thrush/vaginal yeast infection with improvements in quality of life. Consumer satisfaction was high.

Exploratory evaluation of tolerability, performance, and cosmetic acceptance of dexpanthenol-containing dermo-cosmetic wash and sun-care products for tattoo aftercare.

Background and Aims: Tattoo prevalence has significantly increased over the last decades. Proper tattoo aftercare, such as cleansing, moisturizing, and protection against sunlight, is essential to prevent complications and to keep the beauty of the tattoo. The tolerability, performance, and cosmetic acceptability of two dexpanthenol-containing dermo-cosmetic products, a wash and a sun-care, were investigated on tattooed skin in two separate trials. Methods: Two single-center, exploratory, open-label cosmetic studies were conducted between August and November 2020 to evaluate the dexpanthenol-containing dermo-cosmetic products. In the first study, healthy adults applied the 2.5% dexpanthenol-containing wash right after their tattoo session daily for 14 consecutive days. In the second study, healthy adults applied the 2.5% dexpanthenol-containing sun-care sun protection factor 50+ cream on existing tattoos that were daily exposed to sunlight for 28 consecutive days. Clinical examination by a dermatologist and self-assessment through subject questionnaires were used to assess the tolerability, acceptance, ease of use, and cosmetic outcomes of both products. Additionally, transepidermal water loss and moisturization assessments were performed to evaluate skin hydration after use of the sun-care product. Results: Both study products were well tolerated, and no product related adverse events were reported during the studies. At least 90% of the study participants appreciated the performance of the dexpanthenol-containing wash and sun-care product, including moisturizing properties, relief of unpleasant sensations, and preservation of the cosmetic appearance of the tattoo. For the sun-care, it was shown that its application supported maintaining the skin barrier of tattooed skin, while keeping it hydrated. Conclusion: The 2.5% dexpanthenol-containing wash and sun-care products are well tolerated and appreciated by tattooed subjects. Hence, they represent valid options for tattoo aftercare in line with current recommendations and practice.

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.

Evaluation of BepanGel Hydrogel Efficacy and Tolerability Using an Abrasive Wound Model in a Within-Person, Single-Center, Randomized, Investigator-Blind Clinical Investigation.

INTRODUCTION: Over the last few years, it has been demonstrated that a moist environment enhances the healing process and reduces scar formation of wounds. Such moist conditions can be created and maintained using hydrogels. The aim of this study was to evaluate wound healing, cooling efficacy, local tolerability, and cosmetic appearance of abrasive wounds treated with BepanGel wound care hydrogel. METHODS: This study was designed as a within-person, single-center, randomized, investigator-blind clinical investigation comparing a hydrogel-treated test field with an untreated test field in an abrasive wound model. In 33 subjects, two small superficial wounds were induced on the non-dominant forearms. Wounds were treated with BepanGel and covered with a standard semi-occlusive wound plaster or covered with a plaster alone for 11 consecutive days. Wound healing efficacy, cooling effect, and tolerability of the treatment were assessed over 12 investigational days. During follow-up at day 31, the cosmetic appearance of the wounds was evaluated. RESULTS: On day 12, the test field treated with BepanGel was completely healed in nearly all subjects (97.0%) in contrast with the test field treated with a plaster alone (18.2%, AUCdays 2-12 p < 0.0001) as assessed by a blinded investigator. Two-thirds of the unblinded subjects indicated an immediate cooling effect of the hydrogel (p = 0.0555). At the end of the investigation, the cosmetic appearance of the BepanGel-treated test fields scored superior to the fields treated with a plaster alone as evaluated by a blinded investigator (p = 0.0005) and the unblinded subjects (p = 0.0078). The hydrogel was generally well tolerated and no signs of infection or adverse events (AEs) related to the treatment were observed. CONCLUSION: This evaluation shows that treatment of superficial cutaneous wounds with BepanGel results in improved wound healing as demonstrated by faster wound closure and a considerably better cosmetic appearance, while providing immediate cooling. TRIAL REGISTRATION NUMBER: EUDAMED-No.: CIV-19-09-029744.