Skin care types, frequencies and products: A cross-sectional study in German institutional long-term care.

AIM: The aim of the study was to describe types and frequencies of skin care interventions and products provided in institutional long-term care. MATERIALS AND METHODS: Baseline data from a cluster randomized controlled trial conducted in nursing homes in Berlin, Germany was collected before randomization. Numbers, proportions and frequencies of washing, showering and bathing, and the application of leave-on products were calculated. Product labels were iteratively and inductively categorized into overarching terms and concepts. RESULTS: A total of n = 314 residents participated in the study. In the majority, washing of the whole body was done once daily, and showering was performed once per week or more rarely. The majority received leave-on products daily on the face and once per week on the whole body. Most of the skin care interventions were delivered by nurses. There was marked heterogeneity in terms of product names, whereas the product names reveal little about the ingredients or composition. CONCLUSION: Personal hygiene and cleansing interventions are major parts of clinical practice in long-term care. Daily washing is a standard practice at the moment. In contrast, leave-on products are used infrequently. To what extent the provided care promotes skin integrity is unclear. Due to the heterogeneity and partly misleading labels of skin care products, informed decision making is difficult to implement at present. GOV IDENTIFIER: NCT03824886.

Effects of a mattress cover with special airflow technology on the structure and function of the sacral and heel skin during loading: A two-arm exploratory crossover trial.

Prolonged mechanical loading of the skin and underlying soft tissue cause pressure ulceration. The use of special support surfaces are key interventions in pressure ulcer prevention. They modify the degree and duration of soft tissue deformation and have an impact on the skin microclimate. The objective of this randomized cross-over trial was to compare skin responses and comfort after lying for 2.5 h supine on a support surface with and without a coverlet that was intended to assist with heat and moisture removal at the patient/surface interface. In addition, physiological saline solution was administered to simulate an incontinence episode on the mattress next to the participants' skin surface. In total, 12 volunteers (mean age 69 years) with diabetes mellitus participated. After loading, skin surface temperature, stratum corneum hydration and skin surface pH increased, whereas erythema and structural stiffness decreased at the sacral area. At the heel skin area, temperature, erythema, and stratum corneum hydration increased. These results indicate occlusion and soft tissue deformation which was aggravated by the saline solution. The differences in skin response showed only minor differences between the support surface with or without the coverlet.

Integrated safety analysis of baricitinib in adults with severe alopecia areata from two randomized clinical trials.

BACKGROUND: Baricitinib, an oral, selective, reversible Janus kinase (JAK)1/JAK2 inhibitor, is an approved treatment for adults with severe alopecia areata (AA) in the USA, European Union and Japan. OBJECTIVES: To report safety data for baricitinib in patients with severe AA from two clinical trials including long-term extension periods. METHODS: This analysis includes pooled patient-level safety data from two trials, an adaptive phase II/III trial (BRAVE-AA1) and a phase III trial (BRAVE-AA2) (ClinicalTrials.gov, NCT03570749 and NCT03899259). Data are reported in three datasets: (i) the placebo-controlled dataset (up to week 36): baricitinib 2 mg and 4 mg vs. placebo; (ii) the extended dataset (up to the data cutoff): patients remaining on continuous treatment with baricitinib 2 mg or 4 mg from baseline; and (iii) the all-baricitinib dataset (all-BARI, up to the data cutoff): all patients receiving any dose of baricitinib at any time during the trials. Safety outcomes include treatment-emergent adverse events (TEAEs), adverse events of special interest and abnormal laboratory changes. Proportions of patients with events and incidence rates (IR) were calculated. RESULTS: Data were collected for 1303 patients who were given baricitinib, reflecting 1868 patient-years of exposure (median 532 days). The most frequently reported TEAEs during the placebo-controlled period (based on the baricitinib 4-mg group) were upper respiratory tract infection, nasopharyngitis, headache, acne and elevated blood creatine phosphokinase (CPK). During the placebo-controlled period, the frequency of acne was higher with baricitinib than placebo, and elevated CPK was higher with baricitinib 4 mg than placebo and baricitinib 2 mg. In all-BARI, the IR of serious infections was low (n = 16, IR 0.8). There was one opportunistic infection (IR 0.1), and 34 cases of herpes zoster (IR 1.8). There was one positively adjudicated major adverse cardiovascular event (myocardial infarction) (IR 0.1), one pulmonary embolism (IR 0.1), three malignancies other than nonmelanoma skin cancer (IR 0.2) and one gastrointestinal perforation (IR 0.1). No deaths were reported. CONCLUSIONS: This integrated safety analysis in patients with severe AA is consistent with the overall safety profile of baricitinib. Some differences with atopic dermatitis were noted that may be attributable to the disease characteristics of AA.

Short anagen hair syndrome: association with mono- and biallelic variants in WNT10A and a genetic overlap with male pattern hair loss.

BACKGROUND: Short anagen hair (SAH) is a rare paediatric hair disorder characterized by a short anagen phase, an inability to grow long scalp hair and a negative psychological impact. The genetic basis of SAH is currently unknown. OBJECTIVES: To perform molecular genetic investigations in 48 individuals with a clinical phenotype suggestive of SAH to identify, if any, the genetic basis of this condition. METHODS: Exome sequencing was performed in 27 patients diagnosed with SAH or with a complaint of short, nongrowing hair. The cohort was screened for variants with a minor allele frequency (MAF) < 5% in the general population and a Combined Annotation Dependent Depletion (CADD) score > 15, to identify genes whose variants were enriched in this cohort. Sanger sequencing was used for variant validation and screening of 21 additional individuals with the same clinical diagnosis and their relatives. Genetic association testing of SAH-related variants for male pattern hair loss (MPHL) was performed using UK Biobank data. RESULTS: Analyses revealed that 20 individuals (42%) carried mono- or biallelic pathogenic variants in WNT10A. Rare WNT10A variants are associated with a phenotypic spectrum ranging from no clinical signs to severe ectodermal dysplasia. A significant association was found between WNT10A and SAH, and this was mostly observed in individuals with light-coloured hair and regression of the frontoparietal hairline. Notably, the most frequent variant in the cohort [c.682T>A;p.(Phe228Ile)] was in linkage disequilibrium with four common WNT10A variants, all of which have a known association with MPHL. Using UK Biobank data, our analyses showed that c.682T>A;p.(Phe228Ile) and one other variant identified in the SAH cohort are also associated with MPHL, and partially explain the known associations between WNT10A and MPHL. CONCLUSIONS: Our results suggest that WNT10A is associated with SAH and that SAH has a genetic overlap with the common phenotype MPHL. The presumed shared biologic effect of WNT10A variants in SAH and MPHL is a shortening of the anagen phase. Other factors, such as modifier genes and sex, may also play a role in the clinical manifestation of hair phenotypes associated with the WNT10A locus.

Health-related quality of life (hrQoL) among patients with primary cicatricial alopecia (PCA): A systematic review.

Cicatricial alopecia may lead to an enormous emotional burden, social distress, and psychological impairment affecting the quality of life. The objective of this review is to systematically describe the health-related quality of life in adults with primary cicatricial alopecia and its subtypes. Studies that (i) reported quality of life in patients with primary cicatricial alopecia or its subtypes; (ii) were original research and not a conference abstract or review (iii) with patients >18 years of age were included in the review. The studies not mentioning quality of life specifically for the cicatricial alopecia cohort were excluded. We searched for literature via OVID in Medline and Embase, in Web of Science, CINAHL, EBSCO (APA PsycArticles, APA PsycInfo, and PSYNDEX Literature), in the Cochrane Library and for grey literature from its inception date till 12 November 2022. The risk of bias was assessed by using the AXIS tool for cross-sectional studies by two independent authors. Thirteen observational cross-sectional and one single-arm study, including 572 patients and eight different instruments, fulfilled the inclusion criteria. Results are descriptively synthesized, and associated factors of quality of life are presented. The data from studies that used the Dermatology Life Quality Index tool (DLQI) showed that more than 70% of the patients have an impaired life quality. While trichodynia and anxiety have a negative effect on the quality of life, disease duration, education, employment, and marital status have no effect. The findings were inconsistent for other factors. Most of these studies failed to justify the sample size. Furthermore, the risk of bias assessment could not surely rule out a non-response bias. Our results suggest that cicatricial alopecia treatments must be integrated with psychosocial intervention and indicate the need for further research with homogenous and more comprehensive tools to identify and address this patient population's unmet mental health needs.

Quality of life in children and adolescents with alopecia areata-A systematic review.

Alopecia areata (AA) is an autoimmune-mediated non-scarring hair loss whose stigmatizing effect may have a severe psychosocial impact. AA has been reported to be correlated with bullying, reduced quality of life (QoL) and psychiatric comorbidities. The effect of AA on QoL in adult patients has been systematically reviewed and found to be detrimental. No systematic evaluation of QoL in children with AA has been performed. The aim of this review is to systematically describe QoL in the child and adolescent population affected by AA. A systematic review of multiple databases and grey literature sources was conducted. Search terms included, but were not limited to, alopecia areata and quality of life. Only studies reporting results on health-related QoL in children and adolescents were included. We evaluated the studies regarding the risk of bias, and conceptual rigour concerning the quality of life and performed a descriptive synthesis of findings. Eight studies met the inclusion criteria, encompassing 358 participants with AA and 64 healthy peers. Seven studies were quantitative using four different standardized questionnaires and scores to measure QoL. One study used a qualitative design. All studies described impairment of children and adolescents' QoL by AA. The most consistently affected QoL domain was embarrassment and self-consciousness. Further psychosocial implications of AA included bullying and limiting participation in school or spare time activities. Existing evidence indicates a substantial impact of AA on QoL in children. In daily clinical practice as well as for developing new treatments QoL in paediatric AA plays a critical role. It should be considered a key outcome in clinical research and decision-making.

Epidemiology of inherited epidermolysis bullosa in Germany.

BACKGROUND: Epidermolysis bullosa (EB) is a rare genetic disorder manifesting with skin and mucosal membrane blistering in different degrees of severity. OBJECTIVE: Epidemiological data from different countries have been published, but none are available from Germany. METHODS: In this population-based cross-sectional study, people living with EB in Germany were identified using the following sources: academic hospitals, diagnostic laboratories and patient organization. RESULTS: Our study indicates an overall EB incidence of 45 per million live births in Germany. With 14.23 per million live births for junctional EB, the incidence is higher than in other countries, possibly reflecting the availability of early molecular genetic diagnostics in severely affected neonates. Dystrophic EB was assessed at 15.58 cases per million live births. The relatively low incidence found for EB simplex, 14.93 per million live births, could be explained by late or missed diagnosis, but also by 33% of cases remaining not otherwise specified. Using log-linear models, we estimated a prevalence of 54 per million for all EB types, 2.44 for junctional EB, 12.16 for dystrophic EB and 28.44 per million for EB simplex. These figures are comparable to previously reported data from other countries. CONCLUSIONS: Altogether, there are at least 2000 patients with EB in the German population. These results should support national policies and pharmaceutical companies in decision-making, allow more precise planning of drug development and clinical trials, and aid patient advocacy groups in their effort to improve quality of life of people with this orphan disease.

Skin Care in Neonates and Infants: A Scoping Review.

BACKGROUND: Skin care is a basic, daily activity performed by formal and informal caregivers from birth until end of life. Skin care activities are influenced by different factors, e.g., culture, knowledge, industrial developments and marketing activities. Therefore, various preferences, traditions, and behaviors exist worldwide including skin care of neonates and infants. The objective of this scoping review was to obtain an overview about the evidence of skin care activities in neonates and infants. Studies from 2010 were eligible if the population was (skin) healthy neonates and infants; if the concept was skin care interventions; and if the context was at home, in a community setting, in a pediatric outpatient service, or in a hospital. We searched for the literature via OVID in MEDLINE and Embase, in the Cochrane Library, in trial registries and for gray literature. SUMMARY: We identified 42 studies since 2010, which examined four main skin care interventions: bathing, wiping, washing, and topical application of leave-on products. Details of interventions were often not reported, and if they were, they were not comparable. The four skin care interventions focused on 13 different care goals, mainly prevention of skin diseases, maintaining skin barrier function, and improving (skin) health. We evaluated effects of skin care interventions using 57 different outcome domains; 39 of 57 were skin-related and 18 were not. Mostly, laboratory or instrumental measurements were used. KEY MESSAGES: Our scoping review identified four skin care interventions with a broad heterogeneity of product categories and application details. Studies in skin care interventions should include all relevant information about product category and application details to ensure comparability of study results. This would be helpful in developing recommendations for formal and informal caregivers. We identified 13 skin care goals. "Maintaining healthy skin/skin barrier function/skin barrier integrity," "prevention of atopic dermatitis," "cleansing," and "improving skin barrier function" were most often allocated to skin care interventions. There is substantial variability regarding outcome domains in skin care research. Our results support the need of developing core outcome sets in the field of skin care in healthy skin, especially in this age-group of neonates and infants.

Enhanced piroctone olamine retention from shampoo for superior anti-dandruff efficacy.

BACKGROUND: Dandruff is a pervasive chronic condition which negatively impacts quality of life. Effective treatment requires efficient delivery of scalp benefit agents that control commensal scalp Malassezia levels. Delivery of benefit agents from shampoos requires balancing many technical parameters to achieve the desired outcome without sacrificing secondary parameters, such as cosmetic attributes. AIM: To develop formulation technologies that increase the shampoo delivery efficiency of the scalp benefit agent piroctone olamine (PO). Increased delivery should result in increased anti-dandruff efficacy. METHODS: Micellar Stability and Association parameters were quantified via dynamic surface tension and nuclear magnetic resonance (NMR) diffusion parameters, respectively. PO delivery has been assessed in vivo both on the scalp surface and follicular infindibula using extraction procedures and analytical analysis. Clinical anti-dandruff efficacy was assessed for an advanced delivery technology prototype in comparison to standard delivery technology. RESULTS: Shampoo prototypes have been developed that increase the delivery efficiency of PO. Both surfactant and polymer coacervate-based approaches have been developed. Decreased micellar stability results in weaker association between PO and micelles, resulting in more efficient PO retention on the scalp surface and delivery to the infundibula. Increased charge density of cationic polymers optimizes coacervation enabling improved PO delivery as well. Increased PO delivery has been shown clinically to result in higher anti-dandruff efficacy as measured by both visible flakes and underlying biomarkers. CONCLUSION: Increased efficiency PO delivery shampoos have been developed by optimization of both surfactant and coacervate parameters. The increased deposition efficiency results in significantly more products with significantly greater anti-dandruff efficacy.

CONTEXTE: Les pellicules sont une maladie chronique omniprésente qui a un impact négatif sur la qualité de vie. Un traitement efficace nécessite une administration efficace d'agents bénéfiques pour le cuir chevelu qui contrôlent les niveaux commensaux de Malassezia. L'administration d'agents bénéfiques à partir de shampooings nécessite d'équilibrer de nombreux paramètres techniques pour obtenir le résultat souhaité sans sacrifier des paramètres secondaires tels que les attributs cosmétiques. BUT: Développer des technologies de formulation qui augmentent l'efficacité d'administration du shampooing de l'agent bénéfique pour le cuir chevelu piroctone olamine (PO). Une livraison accrue devrait entraîner une efficacité antipelliculaire accrue. MÉTHODES: La stabilité micellaire et les paramètres d'association ont été quantifiés via les paramètres de tension superficielle dynamique et de diffusion RMN, respectivement. L'administration de PO a été évaluée in vivo à la fois sur la surface du cuir chevelu et sur l'indibula folliculaire à l'aide de procédures d'extraction et d'analyses analytiques. L'efficacité antipelliculaire clinique a été évaluée pour un prototype de technologie d'administration avancée par rapport à la technologie d'administration standard. RÉSULTATS: Des prototypes de shampooing ont été développés pour augmenter l'efficacité de livraison des PO. Des approches à base de tensioactifs et de coacervats polymères ont été développées. Une diminution de la stabilité micellaire entraîne une association plus faible entre le PO et les micelles, ce qui entraîne une rétention plus efficace du PO sur la surface du cuir chevelu et une livraison à l'infundibula. L'augmentation de la densité de charge des polymères cationiques optimise la coacervation, permettant également une meilleure administration de PO. Il a été démontré cliniquement que l'augmentation de l'administration de PO entraîne une efficacité antipelliculaire plus élevée, mesurée à la fois par les squames visibles et les biomarqueurs sous-jacents. CONCLUSION: Des shampooings à libération de PO à efficacité accrue ont été développés en optimisant à la fois les paramètres du tensioactif et du coacervat. L'efficacité de dépôt accrue se traduit par beaucoup plus de produits avec une efficacité antipelliculaire nettement supérieure.

The prevalence and severity of dry skin and related skin care in older adult residents in institutional long-term care: A cross-sectional study.

OBJECTIVES: To identify possible factors associated with different severities of xerosis cutis and to describe possible associations between (skin) care dependency and application of moisturizers. DESIGN: Cross-sectional study using baseline data from a cluster-randomized controlled trial. Demographic and health characteristics, skin physiological measurements, functional abilities and application of moisturizers were compared between the participants with mild and severe dry skin. Frequency of moisturization were also compared based on the participants' skin care dependency. RESULTS: The more distal the body area, the more severe xerosis were observed. There were no or minor differences between the groups, except for the stratum corneum hydration and skin surface pH. Participants with severe xerosis received moisturizers less often. Skin care dependent residents received moisturizers frequently. CONCLUSION: There is under-application regarding xerosis cutis treatment in long-term care. Skin care provided by nurses, in adequate frequencies, might be helpful compared to skin care performed by the residents themselves.

A multicentre, randomised, parallel-group, double-blind, vehicle-controlled and open-label, active-controlled study (versus amorolfine 5%), to evaluate the efficacy and safety of terbinafine 10% nail lacquer in the treatment of onychomycosis.

BACKGROUND: Onychomycosis is a difficult-to-treat fungal nail infection whose treatment can involve systemic or topical antifungal approaches. OBJECTIVES: To assess the efficacy and safety of terbinafine 10% nail lacquer in distal-lateral subungual onychomycosis (DLSO). PATIENTS/METHODS: Patients with mild-to-moderate DLSO were randomised (3:3:1) to receive double-blind topical terbinafine 10% (n = 406) or its vehicle (n = 410) administered once daily for 4 weeks and then once weekly for 44 weeks, or open-label topical amorolfine 5% (n = 137) for 48 weeks, with a 12-week follow-up period. The primary efficacy endpoint, complete cure rate at Week 60, was a composite of negative potassium hydroxide (KOH) microscopy, negative culture for dermatophytes and no residual clinical involvement of the target big toenail. RESULTS: Complete cure rates at Week 60 in the terbinafine, vehicle and amorolfine groups were 5.67%, 2.20% and 2.92%, respectively (odds ratio (OR) vs vehicle = 2.68; 95% confidence intervals (CI): 1.22-5.86; p = .0138). Statistically significant differences in responder (negative KOH and negative culture and ≤10% residual clinical involvement) and mycological cure rates (negative KOH and negative culture) at Week 60 were obtained between terbinafine and vehicle. Terbinafine was well-tolerated with no systemic adverse reactions identified; the most common topical adverse reactions were erythema and skin irritation. CONCLUSIONS: Terbinafine 10% nail lacquer was an effective treatment for mild-to-moderate onychomycosis improving both clinical and mycological criteria compared with vehicle. Furthermore, there may be some benefits compared to the currently available topical agent, amorolfine 5%. Treatment was well-tolerated and safe.

[Frontal fibrosing alopecia-update]. / Frontal fibrosierende Alopezie ­ aktuelles Wissen.

The number of patients presenting with frontal fibrosing alopecia (FAA) is increasing not only in hair clinics. The recognition of the peculiar clinical pattern and associated symptoms is an important prerequisite to ensure adequate counseling and therapeutic management of the patients. Experimental studies and a range of case series give first insights into the pathogenesis, possible trigger factors, clinical course of disease and treatment options. The clinical spectrum of FFA extends beyond the typical recession of the frontal hair line initially observed in postmenopausal women. Younger women, men and rarely adolescents may also be affected. Band-like extension to the occiput, diffuse bitemporal hair thinning, eyebrow and body hair involvement as well as facial papules are part of the clinical spectrum. Similar to lichen planopilaris, inflammation and fibrosis with involvement of the stem cell region result in permanent loss of hair follicles. Which additional factors contribute to the characteristic pattern remains to be elucidated. Currently, therapeutic management largely relies on anti-inflammatory treatment with combined topical, intralesional and systemic administration depending on disease activity. The chronic progressive course, sometimes even in the absence of pronounced inflammation remains a challenge for both the affected individuals and the treating physicians. Controlled studies are required to develop evidence-based recommendations and to explore novel treatment strategies.

Alopecia areata - Current understanding and management.

Alopecia areata (AA) is a chronic, immune-mediated disease characterized by acute or chronic non-scarring hair loss, with a heterogeneity in clinical manifestations ranging from patchy hair loss to complete scalp and body hair loss. An overview of the up-to-date pathophysiology and the underlying signaling pathways involved in AA together with diagnostic and therapeutic recommendations will be provided. Current treatments, including topical, systemic and injectable interventions show varying response and frequent relapses reflecting the unmet clinical need. Thus, the new emerging concepts and therapeutic approaches, including Janus kinase inhibitors are eagerly awaited. Traditional and emerging therapies of AA will be discussed, in order to provide physicians with guidance for AA management. Since the latter is so challenging and often tends to take a chronic course, it can have an enormous psychosocial burden on patients, compromising their quality of life and often causing depression and anxiety. Therefore, the psychosocial aspects of the disease need to be evaluated and addressed, in order to implement appropriate psychological support when needed.

The effect of a basic skin care product on the structural strength of the dermo-epidermal junction: An exploratory, randomised, controlled split-body trial.

Skin ageing is associated with various structural alterations including a decreased strength of the dermo-epidermal adhesion increasing the risk for shear type injuries (skin tears). Topical applications of basic skin care products seem to reduce skin tear incidence. The suction blister method leads to the artificial and controlled separation of dermis and epidermis. Therefore, time to blister formation may be used as outcome measuring the strength of dermo-epidermal adhesion. We conducted an exploratory, randomised, controlled trial with a split-body design on forearms in healthy female subjects (n = 12; mean age 70.3 [SD 2.1] years). Forearms assigned to the intervention were treated twice daily with petrolatum for 8 weeks. Suction blisters were induced on forearms after 4 and 8 weeks and time to blister formation was measured. Stratum corneum and epidermal hydration were measured and epidermal thickness was assessed via optical coherence tomography. Time to blistering was longer and stratum corneum as well as epidermal hydration was consistently higher in intervention skin areas. We conclude that topical application of basic skin care products may improve mechanical adhesion of the dermo-epidermal junction and that the parameter "time to blistering" is a suitable outcome to measure dermo-epidermal adhesion strength in clinical research.

Comparing the effects of three different multilayer dressings for pressure ulcer prevention on sacral skin after prolonged loading: An exploratory crossover trial.

Evidence suggests that preventive dressings applied on sacral skin help to prevent pressure ulcers. However, possible performance differences of different dressing types are unclear. An exploratory randomized crossover trial with intra-individual comparisons was conducted to compare the effects of three different multi-layer foam dressings (Mepilex Border Sacrum, ALLEVYN Life Sacrum and Optifoam Gentle Sacrum) compared to no dressing on the sacral skin. Healthy female volunteers (n = 12, mean age 72 years) wore three different dressings on their sacral skin for 3.5 hours while lying supine on a standard hospital mattress. At regular intervals, subjects performed standardized movements to enhance shear loads. Skin surface temperature, stratum corneum hydration, erythema, skin roughness and the interleukin 1 alpha (IL-1α) concentration per total protein were measured at baseline and after the lying periods. After 3.5 hours, the median skin temperature increased in all four groups between 3.0°C and 3.8°C with only minor differences between the no dressing and the dressing groups. Median stratum corneum hydration increased during the lying period in all groups with highest increases in the Optifoam Gentle Sacrum (7.3 arbitrary units) and no dressing group (7.0 arbitrary units). There was a median decrease of the mean roughness (Rz) in the Optifoam Gentle Sacrum group of -6.3 µm but no relevant changes in the other groups. After loading, the erythema index was highest in the ALLEVYN Life Sacrum and no dressing groups. Highest releases of IL-1α were observed in the ALLEVYN Life Sacrum and Optifoam Gentle Sacrum groups, in the Mepilex Border Sacrum group changes were minor. Study results indicate, that the application of preventive dressings on sacral skin during loading do not cause additional occlusion compared to loading without dressings when lying supine. Different dressings cause different cutaneous responses during loading.

The Alopecia Areata Consensus of Experts (ACE) study part II: Results of an international expert opinion on diagnosis and laboratory evaluation for alopecia areata.

BACKGROUND: We previously reported the Alopecia Areata Consensus of Experts study, which presented results of an international expert opinion on treatments for alopecia areata. OBJECTIVE: To report the results of the Alopecia Areata Consensus of Experts international expert opinion on diagnosis and laboratory evaluation for alopecia areata. METHODS: Fifty hair experts from 5 continents were invited to participate in a 3-round Delphi process. Consensus threshold was set at greater than or equal to 66%. RESULTS: Of 148 questions, expert consensus was achieved in 82 (55%). Round 1 consensus was achieved in 10 of 148 questions (7%). Round 2 achieved consensus in 47 of 77 questions (61%). The final face-to-face achieved consensus in 25 of 32 questions (78%). Consensus was greatest for laboratory evaluation (12 of 14 questions [86%]), followed by diagnosis (11 of 14 questions [79%]) of alopecia areata. Overall, etiopathogenesis achieved the least category consensus (31 of 68 questions [46%]). LIMITATIONS: The study had low representation from Africa, South America, and Asia. CONCLUSION: There is expert consensus on aspects of epidemiology, etiopathogenesis, clinical features, diagnosis, laboratory evaluation, and prognostic indicators of alopecia areata. The study also highlights areas where future clinical research could be directed to address unresolved hypotheses in alopecia areata patient care.

A Melanocortin-4 Receptor Agonist Induces Skin and Hair Pigmentation in Patients with Monogenic Mutations in the Leptin-Melanocortin Pathway.

BACKGROUND AND OBJECTIVES: Gene mutations within the leptin-melanocortin signaling pathway lead to severe early-onset obesity. Recently, a phase 2 trial evaluated new pharmacological treatment options with the MC4R agonist setmelanotide in patients with mutations in the genes encoding proopiomelanocortin (POMC) and leptin receptor (LEPR). During treatment with setmelanotide, changes in skin pigmentation were observed, probably due to off-target effects on the closely related melanocortin 1 receptor (MC1R). Here, we describe in detail the findings of dermatological examinations and measurements of skin pigmentation during this treatment over time and discuss the impact of these changes on patient safety. METHODS: In an investigator-initiated, phase 2, open-label pilot study, 2 patients with loss-of-function POMC gene mutations and 3 patients with loss-of-function variants in LEPR were treated with the MC4R agonist setmelanotide. Dermatological examination, dermoscopy, whole body photographic documentation, and spectrophotometric measurements were performed at screening visit and approximately every 3 months during the course of the study. RESULTS: We report the results of a maximum treatment duration of 46 months. Skin pigmentation increased in all treated patients, as confirmed by spectrophotometry. During continuous treatment, the current results indicate that elevated tanning intensity levels may stabilize over time. Lips and nevi also darkened. In red-haired study participants, hair color changed to brown after initiation of setmelanotide treatment. DISCUSSION: Setmelanotide treatment leads to skin tanning and occasionally hair color darkening in both POMC- and LEPR-deficient patients. No malignant skin changes were observed in the patients of this study. However, the results highlight the importance of regular skin examinations before and during MC4R agonist treatment.

Reliability and agreement of instrumental skin barrier measurements in clinical pressure ulcer prevention research.

In skin and wound research the instrumental measurement of skin function is established. Despite the widespread use, empirical evidence about measurement errors is widely lacking. The aim of this study was to measure reliability and agreement of skin temperature, transepidermal water loss, epidermal hydration, and erythema at the heel and sacral skin. Four experienced researchers performed skin measurements in 15 subjects. Lowest reliability was observed for transepidermal water loss at the sacral skin (ICC (1) 0.46 (95% CI 0.00-0.78)) and highest for skin temperature at the heel skin (ICC (1) 0.99 (95% CI 0.99-1.00)). Lowest Standard Errors of Measurement were calculated for skin temperature measurements at the heels (0.11°C) and highest for erythema measurements at the sacral skin (26.7 arbitrary units). There was a clear association between variability of estimates and reliability coefficients. Single measurements of skin temperature, stratum corneum, and epidermal hydration at the sacral and heel skin areas can be used in clinical research and practice. Means of at least two measurements should be used for estimating transepidermal water loss and erythema. Evidence is needed to inform researchers about relative and absolute measurement errors of commonly applied instruments and measurements in skin and wound research.

Effects of loading and prophylactic dressings on the sacral and heel skin: An exploratory cross-over trial.

Pressure ulcers/injuries are caused by sustained loading and deformation of skin and underlying soft tissues. Prophylactic dressings are recommended as an adjunct to other preventive measures such as repositioning and offloading. The aim of this study was to investigate the effects of prophylactic soft silicone multi-layered foam dressings on the skin structure and function of the two most common pressure areas, sacrum and heel, with and without loading. An exploratory randomised cross-over trial using intra-individual comparisons was conducted. Eight healthy volunteers (mean age 27.5 years) were assigned to three groups and either spent 2.5 hours on a standard hospital mattress lying in supine position with and without dressings or spent 2.5 hours with dressings applied but without loading. Skin temperature, stratum corneum, and epidermal hydration increased in all groups irrespective of wearing a dressing and/or loading. Mean roughness decreased at the heels. Reactive hyperaemia and the release of interleukin 1 alpha were associated with loading only. Results suggest that the occlusive effects of dressings are similar or only slightly greater than those observed with non-loading or loading without dressings. Thus, a dressing does not cause additional irritation or skin changes during loading but it may reduce the inflammatory response.

The role of the microbiome in scalp hair follicle biology and disease.

The skin surface microbiome and its role in skin diseases have received increasing attention over the past years. Beyond, there is evidence for a continuous exchange with the cutaneous immune system in healthy skin, where hair follicles (HFs) provide unique anatomical niches. Especially, scalp HFs form large tubular invaginations, which extend deeply into the skin and harbour a variety of microorganisms. The distinct immunology of HFs with enhanced immune cell trafficking in superficial compartments in juxtaposition to immune-privileged sites crucial for hair follicle cycling and regeneration makes this organ a highly susceptible structure. Depending on composition and penetration depth, microbiota may cause typical infections, but may also contribute to pro-inflammatory environment in chronic inflammatory scalp diseases. Involvement in hair cycle regulation and immune cell maturation has been postulated. Herein, we review recent insights in hair follicle microbiome, immunology and penetration research and discuss clinical implications for scalp health and disease.