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Enzo Berardesca,1 Adriana Bonfigli,2 Claudia Cartigliani,2 Delphine Kerob,3 Jerry Tan4 1Phillip Frost Department of Dermatology, University of Miami, Miami, FL, USA; 2Clinical Evaluations, ISPE, Milano, Italy; 3International Scientific Affairs, Cosmetic Active International, Levallois-Perret, France; 4Department of Medicine and Windsor Clinical Research Inc Western University, Windsor, ON, CanadaCorrespondence: Enzo Berardesca, Phillip Frost Department of Dermatology, University of Miami, Miami, FL, USA, Tel +393486962500, Email berardesca@berardesca.itPurpose: Rosacea is a common facial dermatosis, with flares induced by exposome factors. M89PF containing Vichy mineralizing water, probiotic fractions, hyaluronic acid, niacinamide and tocopherol repairs the skin barrier and reinforces skin defences against exposome factors. This study assessed the benefit of M89PF in subjects with rosacea associated with erythema and sensitive skin during the Covid-19 pandemic using protective face masks.Methods: M89PF was compared to usual skin care in a randomized, split-face study, for 30 days in subjects with rosacea associated with erythema and sensitive skin. Clinical evaluations included erythema, desquamation, skin tightness, dryness, burning sensation, itching, stinging, stinging test, and local tolerability. Instrument evaluations included erythema, skin hydration and TEWL. Subject satisfaction was also assessed.Results: Erythema significantly improved with M89PF at both time points (p< 0.01 at D15, and p< 0.001 at D30). Skin sensitivity assessed by the skin stinging test improved significantly (p< 0.01) with M89PF at D30, compared to baseline and usual skin care. Skin erythema, tightness, dryness, hydration and TEWL significantly improved (p≤ 0.05) with M89PF at D15 and D30, versus baseline and the untreated side. Subjects were highly satisfied with M89PF at D15 and D30. Tolerance was very good in all subjects.Conclusion: In subjects with rosacea, M89PF significantly reduces erythema, skin tightness, dryness and TEWL, and improves skin hydration and skin sensitivity, even when using protective masks. M89PF is well tolerated and received high satisfaction ratings.ClinicalTrials.gov. No: NCT05562661.Keywords: rosacea, skin barrier, exposome, erythema, sensitive skin

Enzo Berardesca,1 Adriana Bonfigli,2 Bernard Cribier,3 Frederic Flament,4 Marco Vicic,4 Delphine Kerob,5 Jerry Tan6 1Phillip Frost Department of Dermatology, University of Miami, Miami, FL, USA; 2ISPE, Milano, Italy; 3Clinique Dermatologique, University Hospital, Strasbourg, France; 4L’Oréal Research and Innovation, Chevilly-Larue, France; 5Laboratoires Vichy International, Levallois-Perret, France; 6Western University, Department of Medicine and Windsor Clinical Research Inc, Windsor, ON, CanadaCorrespondence: Enzo BerardescaPhillip Frost Department of Dermatology, University of Miami, Miami, FL, USATel +1 393486962500Email berardesca@berardesca.itObjective: This study assessed the efficacy and tolerability of M89 in patients with rosacea associated with erythema and sensitive skin.Methods: Intra-individual study in a split-face design comparing after 30 days M89 twice daily and usual skin care in 20 adult subjects with rosacea and sensitive skin. M89 contains 89% Vichy volcanic mineralizing water (VVMW) and 0.4% hyaluronic acid. It is hypoallergenic and contains no perfume and this convenes in rosacea. Contained minerals reinforce the natural defences of the skin in restoring the natural skin barrier, stimulating antioxidant activity and reducing inflammation, commonly observed in subjects with rosacea. Clinical evaluations included assessment of erythema, desquamation, papules and pustules, skin tightness, dryness, burning sensation, itching, stinging and stinging test as well as local tolerability. Instrumental evaluations included skin hydration and TEWL. Subject satisfaction was assessed at Days 15 and 30. Demodex density was assessed at Day 30.Results: A significant superiority of M89 over the standard skin care was observed for erythema, skin tightness and dryness (all P≤ 0.05) as early as Day 15, the skin stinging test was significantly in favour of M89 (P< 0.05 at Day 15 and P< 0.01 at Day 30) and for skin hydration (P< 0.0001) at Day 15 and 30 with no difference in mean Demodex density between M89 and usual skin care after 30 days. Tolerance was excellent and subject satisfaction very high.Conclusion: Study results concerning M89 are encouraging for its use either alone or as an adjuvant daily skin care to topical medication in patients with persistent centrofacial erythema of rosacea with no more than 3 papules and pustules.Keywords: rosacea, sensitive skin, Vichy volcanic mineralizing water, M89, split face

Gianni Paulis,1,2 Enzo Berardesca31Andrology Center, Villa Benedetta Clinic, Rome, Italy; 2Department of Uro-andrology, Castelfidardo Medical Team, Rome, Italy; 3Department of Clinical Dermatology, S. Gallicano Dermatological Institute, Rome, ItalyAbstract: Lichen sclerosus (LS) is an autoimmune chronic inflammatory disease usually involving the anogenital skin of both sexes; more rarely LS exclusively involves extragenital areas. As a chronic inflammatory disease, in most cases, LS evolves and progresses causing scleroatrophy of the skin or scars which may cause stenosis in the affected areas. A few LS patients are at risk of developing squamous cell carcinoma in their lifetime, but appropriate long-term treatment diminishes the possibility of a malignant evolution. Oxidative stress (OS) has been proven to play a role not only in the pathogenesis of LS, but also in the development and progression of the disease. OS, by causing DNA damage and lipid peroxidation, contributes directly to the possible malignant transformation of LS. Moreover, the increase in oxidative DNA damage is associated with mutations in tumor suppressor genes. Considering the role that OS plays in LS, therapeutic use of antioxidants appears to be rational and possible, in association with other treatments. Antioxidants would counteract the oxidative DNA damage, which is the most important factor for the progression of LS and its malignant transformation.Keywords: lichen sclerosus, oxidative stress, reactive oxygen species, oxidative damage, antioxidant therapy, squamous cell carcinoma

Exposome aggressions are known to weaken certain skin functions, such as skin barrier and skin defense functions. Vichy volcanic mineralizing water (VVMW) percolates through volcanic and magmatic rocks in the Auvergne region in France to create a pure, highly mineralized water containing 15 minerals for a total mineral concentration of 5.2 g/L. Here, we provide an overview of the main results of in vitro and ex vivo studies (keratinocyte cultures, 3D reconstructed skin model, skin explants) and clinical studies to evaluate the effect of VVMW on key skin functions to help elucidate how it counteracts exposome aggressions on the skin. Properties to strengthen the skin barrier: VVMW stimulated the synthesis of tight junction proteins and keratinocyte differentiation markers in vitro. In clinical studies, VVMW accelerated cell turnover and improved skin hydration. Properties to strengthen skin antioxidant defense: VVMW stimulated the expression of antioxidant defense markers and had a higher stimulatory effect than a competitor thermal water on the expression of superoxide dismutase, catalase, and glutathione peroxidase in keratinocytes in vitro. In vivo, VVMW restored endogenous catalase activity after exposure to UVA radiation. Anti‐inflammatory action: VVMW reduced substance P‐induced inflammation ex vivo and lactic acid‐induced stinging in vivo. Topical application of VVMW in subjects with sensitive skin showed soothing and decongestant effects by reducing skin dryness and erythema. After sodium lauryl sulfate ‐induced skin barrier disruption, recovery from redness and erythema was faster following application of VVMW compared to a competitor water or untreated skin. These studies illustrate that VVMW has unique properties to repair and regenerate the skin barrier, as well as to strengthen antioxidant and immune defenses, which help protect the skin against exposome aggressions. [ABSTRACT FROM AUTHOR]

The special interest group on sensitive skin of the International Forum for the Study of Itch previously defined sensitive skin as a syndrome defined by the occurrence of unpleasant sensations (stinging, burning, pain, pruritus and tingling sensations) in response to stimuli that normally should not provoke such sensations. This additional paper focuses on the pathophysiology and the management of sensitive skin. Sensitive skin is not an immunological disorder but is related to alterations of the skin nervous system. Skin barrier abnormalities are frequently associated, but there is no cause and direct relationship. Further studies are needed to better understand the pathophysiology of sensitive skin – as well as the inducing factors. Avoidance of possible triggering factors and the use of well‐tolerated cosmetics, especially those containing inhibitors of unpleasant sensations, might be suggested for patients with sensitive skin. The role of psychosocial factors, such as stress or negative expectations, might be relevant for subgroups of patients. To date, there is no clinical trial supporting the use of topical or systemic drugs in sensitive skin. The published data are not sufficient to reach a consensus on sensitive skin management. In general, patients with sensitive skin require a personalized approach, taking into account various biomedical, neural and psychosocial factors affecting sensitive skin. [ABSTRACT FROM AUTHOR]

Octocrylene or octocrilene is an organic ultraviolet (UV) filter which absorbs mainly UVB radiation and short UVA wavelengths. It is used in various cosmetic products to either provide an appropriate sun protection factor in sunscreen products or to protect cosmetic formulations from UV radiation. There is no discussion that UV filters are beneficial ingredients in cosmetics since they protect from skin cancer, but octocrylene has been recently incriminated to potentially induce adverse effects on the endocrine system in addition to having allergic and/or photoallergic potential. However, the substance has the advantage to work synergistically with other filters allowing a beneficial broad photoprotection, e.g. it stabilizes the UVA filter avobenzone (i.e. butylmethoxydibenzoylmethane). Like all chemicals used in cosmetics, the safety profile of octocrylene is constantly under assessment by the European Chemical Agency (ECHA) since it has been registered according to the European regulation Registration, Evaluation, Authorisation and Restriction of Chemicals. Summaries of safety data of octocrylene are publicly available on the ECHA website. This review aims to present the main safety data from the ECHA website, as well as those reported in scientific articles from peer‐reviewed journals. The available data show that octocrylene does not have any endocrine disruption potential. It is a rare sensitizer, photocontact allergy is more frequent and it is considered consecutive to photosensitization to ketoprofen. Based on these results, octocrylene can be considered as safe when used as a UV filter in cosmetic products at a concentration up to 10%. [ABSTRACT FROM AUTHOR]

Indoor and outdoor airborne pollutants modify our environment and represent a growing threat to human health worldwide. Airborne pollution effects on respiratory and cardiac health and diseases have been well established, but its impact on skin remains poorly described. Nonetheless, the skin is one of the main targets of pollutants, which reach the superficial and deeper skin layers by transcutaneous and systemic routes. In this review, we report the outcomes of basic and clinical research studies monitoring pollutant levels in human tissues including the skin and hair. We present a current understanding of the biochemical and biophysical effects of pollutants on skin metabolism, inflammatory processes and oxidative stress, with a focus on polyaromatic hydrocarbons and ground‐level ozone that are widespread outdoor pollutants whose effects are mostly studied. We reviewed the literature to report the clinical effects of pollutants on skin health and skin ageing and their impact on some chronic inflammatory skin diseases. We also discuss the potential interactions of airborne pollutants with either ultraviolet radiation or human skin microbiota and their specific impact on skin health. [ABSTRACT FROM AUTHOR]

The skin is a complex barrier organ made of a symbiotic relationship between microbial communities and host tissue via complex signals provided by the innate and the adaptive immune systems. It is constantly exposed to various endogenous and exogenous factors which impact this balanced system potentially leading to inflammatory skin conditions comprising infections, allergies or autoimmune diseases. Unlike the gut and stool microbiome which has been studied and described for many years, investigations on the skin or scalp microbiome only started recently. Researchers in microbiology and dermatology started using modern methods such as pyrosequencing assays of bacterial 16S rRNA genes to identify and characterize the different microorganisms present on the skin, to evaluate the bacterial diversity and their relative abundance and to understand how microbial diversity may contribute to skin health and dermatological conditions. This article aims to provide an overview on the knowledge about the skin microbiota, the microbiome and their importance in dermatology. [ABSTRACT FROM AUTHOR]

Background. The therapeutic management of psoriasis includes conventional treatments as well as the new generation of highly effective TNF-α inhibitors. However, psoriasis has proven to be a complex therapeutic challenge and treatment failures are not uncommon.Thus, laboratory biomarkers of disease progression/therapeutic efficacy may greatly help in the clinical management of psoriasis. Aims. To identify laboratory biomarkers for clinical management and therapeutic monitoring of psoriasis. Methods. An observational study performed on 59 patients, presenting moderate to severe psoriasis, undergoing treatment with anti-TNF-α agents (etanercept, adalimumab, and infliximab). Soluble and cellular immune/inflammatory parameters were assessed at baseline and after 12 and 24weeks of treatment. Results. Clinical efficacy was achieved in 88% of the subjects at 12 weeks, reaching 90% after 24 weeks. IL-6 and IL-22, which were elevated at baseline, were significantly reduced, in association with a significant decrease of CLA+ T cells and an increase of Treg lymphocytes. T, B, and NK cell subsets and T cell response to recall antigens did not show any evidence of immune suppression. Conclusions. Immune/inflammatory parameters including IL-6 and IL-22, CLA+ T cells, and Treg lymphocytes may prove to be valuable laboratory tools for the clinical and therapeutic monitoring of psoriasis. [ABSTRACT FROM AUTHOR]

Background: Radiographic examination (Rx) is still the best method to obtain an accurate diagnosis of psoriatic arthritis (PsA). Nevertheless, ultrasound (US) examination of the potentially involved joints has started to play a leading role. The sensitivity and specificity of a scan can be determined by contrast enhancement in the diagnosis of arthritis during PsA in comparison with basal US with MRI. Methods: Our study was made on 22 uninformed patients showing clinical suspicion of PsA. The patients were submitted to clinical evaluation, Rx, US with and without contrast enhancement and MRI. The parameters evaluated by basal US were effusion, synovial hypertrophy, positiveness to color power Doppler signals and bone erosion. Results: Contrast-enhanced US (CEUS) seems to amplify small alterations previously detected by US and, moreover, increases the diagnostic confidence in cases of suspected symptomatology with a negative diagnosis. Finally, CEUS appears to have a concordance of almost 100% with the results of MRI with contrast enhancement. Conclusion: US appears to be an effective method for detecting the alterations in bone outline and soft tissues, such as synovitis. Furthermore, US provides useful information concerning the evolution of vascularization and the dynamic behavior of tendons. [ABSTRACT FROM AUTHOR]

This study was designed to assess the efficacy and tolerability of MAS065D (Xclair™) compared to a vehicle control in the management of radiation dermatitis in patients receiving radiotherapy for breast cancer. Twenty patients were randomized blindly to use the two study substances, three times daily, on separate sections of irradiated skin throughout the duration of radiotherapy and for two weeks afterwards. Patients were monitored before therapy, weekly during therapy, and for 2 weeks after radiotherapy was completed. Skin appearance according to National Cancer Institute (NCI) toxicity criteria, erythema rating, transepidermal water loss (TEWL), skin hydration, patients' view of itch, pain, acceptance, and view of each cream and adverse events, were monitored; at the final visit patients and investigators expressed their preference for one of the creams. MAS065D showed statistically significant superiority in the outcomes of NCI grading for radiation dermatitis and erythema. Patients' and investigators' preferences for one of the study substances were statistically in favor of MAS065D. Very few patients recorded nonzero itch and pain scales, so no significant differences emerged between the two groups. It was concluded that MAS065D can provide an effective option for managing radiation dermatitis although further studies are needed to assess its effect on pain and itch. [ABSTRACT FROM AUTHOR]

Erosive pustular dermatosis of the scalp (EPDS) is a rare entity characterized by pustular, erosive and crusted lesions of the scalp with progressive scarring alopecia. The aetiology is unknown, but predisposing factors have been reported such as trauma, skin grafting, prolonged exposure to UV light of a bald scalp as well as co-existence of auto-immune diseases. Laboratory data, bacteriological and mycological investigations and histopathology are generally not diagnostic. A 45-year-old Caucasian man with 1-year-old pustular, erosive and crusted lesions on his bald scalp was seen. Laboratory data, including auto-immunity, bacteriological and mycological investigations were negative. Histopathology was not diagnostic showing a diffuse polymorphous infiltrate involving the dermis. A diagnosis of EPDS was made. The patient was treated with topical and systemic antibiotics and steroids as well as oral nimesulide with no or partial response. Consequently, isotretinoin (0.75 mg/kg/day) was started obtaining complete resolution in few months. No relapse after 1 year of follow-up was seen. EPDS represents a distinct disease with a history of relapsing and unsatisfactory response to common treatments. Systemic retinoids may be considered as a potentially resolutive choice. Copyright © 2005 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]