Formulating O/W Emulsions with Plant-Based Actives: A Stability Challenge for an Effective Product

Quality, safety, and efficacy concerns added to instability, poor absorption, and the dispersion of actives are common problems while formulating plant-based cosmetics. Furthermore, a correct balance between the stability of the emulsion, the sensory profile, and the high efficacy has to be considered to formulate an effective product. In this paper, we demonstrate that rheology is a methodological tool that can be used while designing a new product. In particular, we developed an O/W emulsion which is easy to spread on irritated skin, and that can soothe the redness and discomfort caused by the exposure to both physical and chemical irritating agents. The green active mixture consists of three natural raw materials: Bosexil\uae, Zanthalene\uae, and Xilogel\uae. Each ingredient has a well-demonstrated efficacy in terms of soothing, anti-itching, and moisturizing properties respectively. Starting from the selection of a new green emulsifying system, through the analysis of the rheological properties, we obtained a stable and easy-to-apply o/w emulsion. The efficacy of the optimized product was assessed in vitro on intact and injured skin using the SkinEthic\u2122 Reconstituted Human Epidermis (RHE) as a biological model

In vivo validation of the multicomponent powder (Vitachelox\uae) against the deposition of polluting ions

Purpose: The purpose of this in vivo study is to evaluate the acute clinical application of a multicomponent powder (Vitachelox\uae), including three naturally occurring standardized extracts rich in polyphenols (grape seed extract, green tea extract, oak wood/bark extract), on healthy volunteers by measuring prevention of any metal deposition within the stratum corneum (SC) following a 6-h exposure period in a polluted environment. Patients and methods: In this in vivo study, we evaluated the skin protective activity of the multicomponent powder formulated in a base emulsion compared to a relevant placebo cream. Using the tape stripping method, SC samples of face skin obtained from 30 healthy volunteers were compared following a 6-h exposure in a polluted area. Results: No statistically significant variations on the amount of heavy metals were found in the samples of SC cells obtained from the hemi-faces treated with the multicomponent powder, with respect to baseline. On the contrary, a significantly higher concentration of heavy metals was found in the cells samples obtained from the hemi-faces treated with the placebo cream. In particular, an increased concentration of heavy metals superior to 100% were found for iron and zinc (+130.2% and +142.6%, respectively; p<0.001). Conclusion: This in vivo study validates and extends previous in vitro findings, indicating that the multicomponent powder allows the prevention of any metal deposition within the SC following exposure in a polluted environment. Our results suggest that the test product could play an effective role in counteracting skin damages induced by air pollution

Soothing and anti-itch effect of quercetin phytosome in human subjects: A single-blind study

Background: We evaluated the ability of quercetin, a natural antioxidant formulated in a specific delivery system, to reduce skin inflammation induced by a variety of stimuli, including UV radiation, stimulation with a histamine solution, or contact with chemical irritants. In particular, we tested the soothing and anti-itch effect of Quercevita\uc2\uae, 1% cream for external use, a formulation characterized by a phospholipids-based delivery system. Patients and methods: The study was a monocentric, single blind trial that enrolled a group of 30 healthy volunteers. The back of each subject was examined to identify four quadrants with no previous skin damage or naevi that were treated in order to induce a controlled and reversible form of skin stress. The areas were treated as follows: no product; Quercevita\uc2\uae 1% cream, 2 mg/cm2; placebo; positive control (a commercially available topical formulation containing 1% dexchlorpheniramine). Results: Only quercetin phospholipids 1% and dexchlorpheniramine 1% achieved a significant reduction in erythema with comparable results: (\ue2\u80\u9310.05% [P=0.00329] for quercetin phospholipids 1% vs \ue2\u80\u9314.05% [P=0.00046] for the positive control). Moreover, quercetin phospholipids 1% and dexchlorpheniramine 1% were both associated with a significant decrease in mean wheal diameter: (\ue2\u80\u9313.25% and \ue2\u80\u9312.23% for dexchlorpheniramine 1%, respectively). Similar findings were reported for the other tested parameters. Conclusion: Quercetin has a skin protective effect against damage caused by a variety of insults, including UV radiation, histamine, or contact with toxic chemical compounds. Indeed, quercetin is able to reduce redness, itching, and inflammation of damaged skin; it may also help restore skin barrier function, increasing hydration, and reducing water loss

The Relevance of Assessing Subjective Experiences of Skin Toxicity During Adjuvant Radiotherapy for Breast Cancer

Purpose: Radiodermatitis is likely to be an inevitable side effect of radiotherapy (RT) but experiencing pain relief during RT might contribute making treatment more acceptable and less impairing. The current study aimed to assess the subjective perceptions and experiences of skin toxicity in a sample of women undergoing adjuvant RT for breast cancer. Methods: Eighty patients were randomly assigned to one out of two groups: treatment (i.e., a newly developed topical product) and control (i.e., standard-of-care). Patients underwent adjuvant RT for 3 weeks. Clinical assessment of radiodermatitis and self-reported levels of pain, relief, and perceptions of treatment response were collected at the initiation of RT (T1), during RT (T2 and T3), and 2 weeks after treatment completion (T4). To assess changes in skin-related QoL, a subgroup of patients completed the Padua Skin-Related QoL questionnaire at T0 (before the initiation of RT) and at T4. Results: A comparable timing of onset and severity of radiodermatitis during treatment was observed in both groups. The treatment group reported lower levels of pain and higher levels of relief compared to the control group when skin toxicity was at its highest levels (T2 and T3). Independent of the group, levels of perceived improvements in clinical status increased over time, whereas skin-related QoL worsened from T0 to T4. Conclusion: Current findings outline the relevance of integrating clinical evaluations of radiodermatitis with patients\u2019 subjective experiences of skin toxicity in interventional studies. Moreover, they provide preliminary evidence about the soothing effect of a newly developed topical product, thus supporting its usefulness of as a supportive care

Vitachelox: Protection of the Skin Against Blue Light-Induced Protein Carbonylation

Protein carbonylation (PC) is a marker of reactive oxygen species-mediated alterations induced by external stimuli such as UV and blue light irradiation. In this study, we investigated the protective effect of Vitachelox®, a mixture of three standardized natural extracts rich in polyphenols, against PC induced by blue light irradiation in human keratinocytes. We tested eight experimental conditions, including Vitachelox® 0.01% and 0.005% w/v, used for 6 or 24 h before irradiation, and a solution of N-acetylcysteine (NAC) as positive control of protection. PC was evaluated by fluorescence microscopy in situ and by absolute quantification (Carbonyl Score) upon protein extraction and separation. Both the in situ visualization study and the carbonyl score showed a considerable increase in protein oxidative damage upon blue light irradiation, and a decrease in PC in the presence of Vitachelox®. In particular, Vitachelox® 0.005% showed superior results compared to NAC in terms of carbonyl score and protein quality, and it was estimated to exert a protective action against blue-light irradiation ranging from 72% (24 h) to 82% (6 h). The protective antioxidant effect of Vitachelox®, together with the anti-inflammatory and anti-microbial properties previously reported, make this natural active ingredient a valuable tool in the maintenance of healthy skin

EVALUATION OF THE SOOTHING EFFECT OF A NATURAL FORMULATION ON RADIOTHERAPY INDUCED DERMATITIS. INSTRUMENTAL, CLINICAL AND PSYCHOLOGICAL ASSESSMENT

Aim of this work is to evaluate the potential efficacy of a topical product based on a combination of natural active ingredients on the reduction of the effects induced on the skin by radiotherapy. The product has been formulated accordingly to the most recent innovations of natural excipients and botanical actives. The combination of active ingredients comprises: a specific boswellia resin extract, standardized in boswellic acids, which are recognized potent anti-inflammatory compounds, formulated in a specific delivery system which was shown to ameliorate skin affinity; a specific lipophilic fraction of Sichuan pepper containing alpha hydroxyl-sanshool, a skin sensitivity modulator; a polysaccharide from tamarind with objectivized hydrating properties. The emulsifying, as well as the preservative system of the formulation, are once again of natural origin. Finally, the overall texture of the product results very light and easy to spread ameliorating the compliance of patients and the use on challenged skin areas. This experimental, double blind controlled trial, foresees the pre-application of the product one week prior to the beginning of the radiotherapy protocol once a day, twice daily during the radiotherapy treatment and again once a day in the two following weeks. The panel of enrolled patients comprises 40 women randomly assigned to the active group and 40 women randomly assigned to the best available treatment group, being this an emollient product standard-of-care used by the hospital. The skin toxicity induced by the treatment is evaluated by the clinical RTOG scoring system, and the severity and timing for the onset of the erythema represents the primary endpoint of the study. An additional primary endpoint is the overall quality of life of the patients which is evaluated by a scientific tool developed by the University of Padua, the \u201cPadua Skin-related QoL Questionnaire\u201d whose data collection and interpretation is followed by psychologists. Additionally, a score defined as PGIC (Patient\u2019s Global Impression of Change) has been collected to evaluate the perceived amelioration and skin care support