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ImportanceSafe and effective long-term treatments for adolescents with moderate to severe atopic dermatitis (AD) are limited.ObjectiveTo evaluate the efficacy and safety of interleukin-13–targeted treatment with tralokinumab monotherapy in adolescents with AD.Design, Setting, and ParticipantsThe 52-week, randomized, double-blinded, placebo-controlled, phase 3 ECZTRA 6 trial was conducted from July 17, 2018, through March 16, 2021, at 72 centers across 10 countries in North America, Europe, Asia, and Australia. Enrolled patients were 12 to 17 years old with moderate to severe AD (Investigator’s Global Assessment [IGA] score ≥3; Eczema Area and Severity Index [EASI] ≥16).InterventionsPatients were randomized (1:1:1) to tralokinumab (150 or 300 mg) or placebo every 2 weeks for 16 weeks. Patients with an IGA score of 0 (clear) or 1 (almost clear) and/or 75% or higher improvement in EASI (EASI 75) at week 16 without rescue medication received maintenance treatment; other patients switched to open-label tralokinumab, 300 mg, every 2 weeks.Main Outcomes and MeasuresPrimary end points at week 16 were an IGA score of 0 or 1 and/or achieving EASI 75. Key secondary end points were a reduction of Adolescent Worst Pruritus Numeric Rating Scale of 4 or more, change in SCORing AD, and change in Children’s Dermatology Life Quality Index from baseline to week 16. Safety end points were the number of adverse events and serious adverse events.ResultsOf 301 patients randomized, 289 comprised the full analysis set (median [IQR] age, 15.0 [13.0-16.0] years; 149 [51.6%] male). More patients receiving tralokinumab, 150 mg, (n = 98), and tralokinumab, 300 mg (n = 97), achieved an IGA score of 0 or 1 without rescue medication at week 16 (21 [21.4%] and 17 [17.5%], respectively) vs placebo (n = 94; 4 [4.3%]) (adjusted difference, 17.5% [95% CI, 8.4%-24.6%]; P P = .002, respectively). More patients receiving tralokinumab, 150 mg (28 [28.6%]), and tralokinumab, 300 mg, (27 [27.8%]) vs placebo (6 [6.4%]) achieved EASI 75 without rescue at week 16 (adjusted difference, 22.5% [95% CI, 12.4%-32.6%]; P P Conclusions and RelevanceIn this randomized clinical trial, tralokinumab was efficacious and well tolerated, supporting its value for treating adolescents with moderate to severe AD.Trial RegistrationClinicalTrials.gov Identifier: NCT03526861

Members of the European Academy of Dermatology and Venereology (EADV) Task Force on Quality of Life (QoL) and Patient Oriented Outcomes reviewed the instruments available for health-related (HR) QoL assessment in vitiligo and together with external vitiligo experts (including representatives of the EADV Vitiligo Task Force) have made practical recommendations concerning the assessment of QoL in vitiligo patients. The Dermatology Life Quality Index (DLQI) was the most frequently used HRQoL instrument, making comparison of results between different countries possible. Several vitiligo-specific instruments were identified. The vitiligo Impact Scale (VIS) is an extensively validated vitiligo-specific HRQoL instrument with proposed minimal important change and clinical interpretation for VIS-22 scores. VIS-22 was developed for use in India, where there are some specific cultural beliefs concerning vitiligo. The EADV Task Force on QoL and Patient Oriented Outcomes recommends use of the DLQI and the Children's Dermatology Life Quality Index (CDLQI) as dermatology-specific instruments in vitiligo. There is a strong need for a valid (including cross-cultural validation) vitiligo-specific instrument that can be either a new instrument or the improvement of existing instruments. This validation must include the proof of responsiveness.

The overall objective of the guideline is to provide up-to-date, evidence-based recommendations for the management of delusional infestation (DI) in adults. Linked Comment: I. Coulson. Br J Dermatol 2022; 187:457.

To undertake a comparison of Cal/BDP cream versus foam for the treatment of plaque psoriasis, with cross-trial population differences accounted for.An anchored matching-adjusted indirect comparison was undertaken, using individual patient data for Cal/BDP cream and published aggregated data for Cal/BDP foam. Altogether, 11 outcomes were analyzed, including PGA success, mPASI75, DLQI-related outcomes and treatment satisfaction across numerous domains. For each outcome an odds ratio or mean difference was calculated to represent the relative efficacy of Cal/BDP cream versus foam. Methods were guided by NICE Decision Support Unit recommendations.After adjustment, baseline characteristics were balanced across treatment arms in each analysis. There were no statistically significant differences in PGA success, mPASI75 or DLQI outcomes between Cal/BDP cream and foam when they were compared after their recommended treatment durations (8 weeks for cream and 4 weeks for foam). For treatment satisfaction after 1 week of treatment, Cal/BDP cream was significantly superior to the Cal/BDP foam in all but one domain of the questionnaire.Cal/BDP cream and Cal/BDP foam have equivalent efficacy and HRQoL (measured in DLQI) outcomes when used for the topical treatment of plaque psoriasis at their recommended treatment durations. A comparison of treatment satisfaction assessments after 1 week of treatment demonstrated that patients find Cal/BDP cream to be more convenient than foam.

Prurigo nodularis (PN), or chronic prurigo, is a distinct disease characterized by the presence of chronic pruritus and multiple localized or generalized pruriginous lesions. While there are few epidemiologic studies describing the prevalence of PN, it is thought to be relatively rare, but is likely underdiagnosed and underrecognized. Management of PN is challenging, and there are no approved drugs that can relieve the distress as well as signs and symptoms caused by PN and its pruritus. Improved understanding of the neuroimmune pathways involved in management of PN have led to discovery and trial of emerging treatments for PN. This publication provides an overview of PN and discusses several of the most promising treatments that are undergoing evaluation.

Background Topical steroid withdrawal (TSW) is a newly described disease characterised by erythema and burning following discontinuation of prolonged use of mid- to high-potency topical corticosteroids. No consensus diagnostic criterion exists. TSW is frequently interpreted as flaring of the underlying disorder or contact allergy to topical treatment. Objectives To better characterise TSW symptomatology, detail our experience with management, and assess the proportion of patients who pursue nonconventional management. Methods A retrospective review of case notes collected from our multidisciplinary service between January 2019 and June 2021 was carried out to identify patients presenting with TSW. Results Nineteen cases of TSW were identified, 15 females and four males. The majority were under 35 years old. Eighteen had atopic dermatitis. The most frequently reported features were redness, skin pain (typically ‘burning’), skin sensitivity, excessive skin flaking, insomnia, and severe itching. There was a high burden of anxiety and depression, with three patients expressing suicidal thoughts. Nonconventional treatments were pursued by approximately half the cohort, some of whom sought private consultation with international dermatologists. Improvements were noted in the context of open psychodermatology consultations with an earlier introduction of conventional management options. Conclusion Many patients report dismissal by dermatology healthcare professionals, often driving them to seek help from unregulated online sources, heightening the burden of mental, social and physical morbidity. Dermatology healthcare professionals need to be aware of TSW, and offer support with shared decision-making when considering treatments.

Atopic dermatitis (AD) is a chronic inflammatory skin disease associated with itch, eczematous lesions and impaired quality of life (QoL). Although the frequency of skin pain in AD is often underestimated, it is associated with a substantial health burden, similar to itch and is known to contribute to sleep disruption and mood disturbance. Abrocitinib is an oral, once-daily, selective Janus kinase-1 inhibitor approved for the treatment of moderate-to-severe AD. In phase 3 clinical trials JADE MONO-1 (NCT03349060) and JADE MONO-2 (NCT03575871), abrocitinib demonstrated rapid relief from itch and skin pain, as well as meaningful improvements in QoL compared with placebo. The interrelationships between abrocitinib treatment and improvements in itch, skin pain and QoL have not yet been investigated. This mediation analysis aimed to characterize the effect of abrocitinib treatment via itch and skin pain on dermatology-specific QoL in patients with AD. Data from JADE MONO-1 and JADE MONO-2 were pooled in this analysis. Adult patients with moderate-to-severe AD received abrocitinib (200 or 100 mg) as monotherapy or placebo for 12 weeks. Three separate models were evaluated whereby QoL was assessed using the Dermatology Life Quality Index (DLQI) score, and itch and skin pain were assessed via the Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) items #1 (How itchy was your skin over the past 24 h?) and #2 (How painful was your skin over the past 24 h?), respectively. The cross-sectional mediation model (CSMM) was run separately at weeks 2, 4, 8 and 12 using all available data at each timepoint. The longitudinal mediation model (LMM), which does not assume independence among measurements of itch, skin pain and DLQI at each timepoint, estimated relationships using all available data from all weeks simultaneously. Based on the results of the CSMM and LMM, a pseudo-steady-state model, in which the relationship among variables was assumed to be the same across timepoints, was applied. Effects with P < 0.05 were considered statistically significant. In the CSMM, the indirect effect of abrocitinib on DLQI mediated via itch was considered approximately stable (24–30%) for the first 8 weeks before increasing at week 12 (42%), while the indirect effect mediated via skin pain was considered approximately stable from week 2 to week 12 (33–41%). In the LMM, the indirect effect of abrocitinib treatment on DLQI mediated via both itch and skin pain was considered approximately stable from week 2 to week 12 (17–26% and 42–48%, respectively). The cross-sectional and longitudinal models were generally consistent and indicated a pseudo-steady-state period between weeks 2 and 12. Using the pseudo-steady-state model, the direct effect of abrocitinib on DLQI was estimated to be 34.8% (P < 0.0001), and the indirect effects mediated via itch and skin pain were estimated to be 19.5% and 45.8%, respectively (P ≤ 0.0001 for both). Improvements in dermatology-specific QoL with abrocitinib are mostly mediated indirectly via a reduction in skin pain and less so by relief of itch. These findings warrant further research to examine to what extent patients consider itch and skin pain as separate concepts in terms of their impact on dermatology-specific QoL.

Atopic dermatitis (AD) is a chronic inflammatory skin disorder characterized by intense itch, skin pain and impaired quality of life. Skin pain is a common and bothersome symptom of AD and increases in prevalence and intensity with worsening disease severity. Abrocitinib is an oral, once-daily, selective Janus kinase-1 inhibitor approved for the treatment of moderate-to-severe AD. Abrocitinib treatment resulted in improvements in skin clearance as well as rapid itch reduction in patients with moderate-to-severe AD across multiple phase 3 studies. Work productivity loss and activity impairment were assessed in the phase 3 JADE MONO-2 (NCT03575871) trial, with greater improvements being associated with abrocitinib treatment compared with placebo. The mechanism(s) through which abrocitinib reduces work productivity loss and activity impairment are unclear. To describe the interrelationships among abrocitinib treatment, itch, skin pain, and work productivity and activity impairment using a mediation modelling analysis in patients with AD. Data from adult patients treated with abrocitinib monotherapy (200 or 100 mg) or placebo in JADE MONO-2 were included in this analysis. As separate outcomes, work productivity loss and activity impairment (outcome variables) were measured by the Work Productivity and Activity Impairment Questionnaire: Atopic Dermatitis version 2.0 (WPAI-AD 2.0). Itch and skin pain (mediator variables) were evaluated using the Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) item #1 (How itchy was your skin over the past 24 h?) and item #2 (How painful was your skin over the past 24 h?), respectively. Mediation modelling was conducted independently for work productivity loss and activity impairment. All available data at week 12 were used in the modelling. Effects with P < 0.05 were considered statistically significant. The direct effects of abrocitinib were estimated to be 7.3% (P = 0.779) and 17.5% (P = 0.258) on work productivity loss and activity impairment, respectively. The indirect effects of abrocitinib treatment on work productivity loss and, separately, on activity impairment mediated via itch were estimated to be 50.6% (P = 0.017) and 20.9% (P = 0.062), respectively, and via skin, pain were estimated to be 42.1% and 61.5%, respectively, (P < 0.05 for both). The indirect effect of abrocitinib treatment on work productivity loss is mediated approximately equally through the reduction in itch severity and skin pain. The effect of abrocitinib treatment on activity impairment is mostly mediated indirectly through the reduction of skin pain, along with a smaller indirect contribution from the reduction in itch. These findings support further research into the extent that patients consider itch and skin pain as separate concepts in terms of their impact on work productivity.

Background\ud Skin conditions have a large emotional, psychological and psychiatric impact on the individual. The ‘All-Party Parliamentary Group on Skin’ (APPGS) commissioned a qualitative survey in order to further explore this relationship alongside the experiences of those accessing services in relation to these difficulties in the UK.\ud \ud Objectives\ud To examine the experiences of UK individuals living with a skin condition and their views of seeking and receiving psychological treatment. This survey formed part of the evidence collected in the preparation of the APPGS, Mental Health and Skin Disease report.\ud \ud Methods\ud A free-text electronic survey was widely distributed by professional bodies and skin related charities. Responses were analysed using descriptive thematic analysis and descriptive statistics. Data for each question was classified and labelled, leading to the development of a coding frame. Inter-rater reliability was assessed using Cohen’s Kappa.\ud \ud Results\ud Five hundred and forty four participants (84% female) completed the survey. The majority of respondents had inflammatory skin diseases such as eczema (43%) or psoriasis (33%). The thematic analysis revealed five key themes associated with: impact on mood; impact of intimacy; impact on activities of daily living; lack of recognition from others of impact; lack of accessible services.\ud \ud Conclusions\ud The survey demonstrates that there is an urgent need to improve both awareness of the impact that skin conditions can have, and for the provision of psychological services to address this impact.

Acne vulgaris is the most common inflammatory dermatosis treated worldwide.1 Acne typically affects younger age groups during a time of physical and social transitions. Acne is often considered a non-serious condition and can be overlooked by medical professionals.2 Recent studies have highlighted the importance of assessing the psychosocial aspect of dermatological conditions to intervene early, provide the necessary psychological support and help prevent suicide.

Introduction Determining optimal treatment for moderate plaque psoriasis can be challenging. Recent studies have demonstrated the effectiveness of calcipotriol and betamethasone dipropionate (Cal/BD) foam in patients with moderate-to-severe plaque psoriasis. Methods This research explored the use of Cal/BD foam in patients with beyond-mild psoriasis (defined as patients eligible for topical treatment, systemic treatment, or combined topical/systemic treatments) using an online questionnaire, retrospective medical-record review, and by capturing the attitudes and treatment approaches of dermatology specialists. Results Data from 409 patients with beyond-mild psoriasis treated with Cal/BD foam were provided by 120 dermatology specialists from Germany, Spain, and the UK. Cal/BD foam was prescribed as monotherapy for most (58%) patients and was considered to be effective. Cal/BD foam was infrequently used in combination with biologics (7%) in this segment; 26% of patients received Cal/BD foam in combination with a non-biologic systemic treatment. Cal/BD foam prescribers generally use topical agents to bridge the waiting time to non-biologic/biologic systemic treatment, and as an add-on to systemic treatment for residual lesions. Conclusions In patients with beyond-mild psoriasis, the most commonly prescribed topical medication was Cal/BD foam, which was regarded as an effective treatment. Further research is needed to determine optimal use of Cal/BD foam in these patients. Supplementary Information The online version contains supplementary material available at 10.1007/s13555-021-00501-3.

Background Chronic urticaria (CU) is a skin condition characterised by repeated occurrence of itchy wheals and/or angioedema for >6 weeks. Aim To provide data demonstrating the real‐life burden of CU in the UK. Methods This UK subset of the worldwide, prospective, non‐interventional AWARE study included patients aged 18–75 years diagnosed with H1‐antihistamine (H1‐AH)‐refractory chronic spontaneous urticaria (CSU) for >2 months. Baseline characteristics, disease activity, treatments, comorbidities and healthcare resource use were documented. Quality of life, work productivity and activity impairment were assessed. Results Baseline analysis included 252 UK patients. Mean age and body mass index were 45.0 years and 29.0 kg/m2, respectively. Most patients were female (77.8%) and had moderate/severe disease activity (mean Urticaria Activity Score over 7 days, 18.4) and a ‘spontaneous’ component to their CU (73.4% CSU; 24.6% CSU and chronic inducible urticaria). Common comorbidities included depression/anxiety (24.6%), asthma (23.8%) and allergic rhinitis (12.7%). A previous treatment was recorded for 57.9% of patients. Mean Dermatology Life Quality Index score was 9.5 and patients reported impairments in work productivity and activity. Healthcare resource use was high. Severity of CSU was associated with gender, obesity, anxiety and diagnosis. Only 28.5% of patients completed all nine study visits, limiting analysis of long‐term treatment patterns and disease impact. Conclusions Adult H1‐AH‐refractory CU patients in the UK reported high rates of healthcare resource use and impairment in quality of life, work productivity and activity at baseline. The differing structures of UK healthcare may explain the high study discontinuation rates versus other countries.

Introduction Clinical trials have shown that psoriasis patients who achieve complete skin clearance are more likely to report no impairment in health-related quality of life (HRQoL) and no psoriasis symptoms versus patients who achieve almost complete skin clearance. However, real-world data are lacking. The objective of this study was to estimate the real-world proportion of moderate-to-severe psoriasis patients on biologic treatment who achieved a Psoriasis Symptom Inventory (PSI) total score of 0 (PSI 0; no symptoms) and a Dermatology Life Quality Index (DLQI) score of 0/1 (DLQI 0/1; no impact on HRQoL), and to study the relationship between patient-reported symptoms and HRQoL versus physician-reported psoriasis severity (Psoriasis Area and Severity Index [PASI]). Methods The PSO-BIO-REAL study was a multinational, prospective, real-world, non-interventional study that included patients aged ≥ 18 years with moderate-to-severe plaque psoriasis who had initiated biologic therapy (either biologic-naïve or had switched biologics [biologic-experienced]). Psoriasis symptoms were evaluated using the PSI, and HRQoL was assessed using the DLQI. Assessments were conducted at baseline and at 6 and 12 months after initiating biologic treatment. Associations between PSI and DLQI with PASI were evaluated using Spearman correlation coefficients. Post-hoc analyses evaluated individual PSI items and the association to PASI response, DLQI and PSI by index biologic. Results At 12 months, 25.5% of patients achieved PSI 0, and 51.2% achieved DLQI 0/1, with greater proportions achieving these scores among biologic-naïve than among biologic-experienced patients. There was a moderate-to-strong correlation between PSI and DLQI scores and PASI scores, with 64.8% of patients with absolute PASI 0 and 19.4% with absolute PASI > 0 ≤ 2 achieving PSI 0 (6 and 12 months pooled). Achievement of response varied by index biologic. Conclusion This study demonstrates that in a real-world setting patients’ QoL improves with skin clearance. The results also demonstrate that the correlation between skin clearance and improvements in HRQoL (DLQI) and psoriasis symptoms (PSI) is not complete, which highlights the importance of considering both patient- and physician-reported outcomes in the assessment of psoriasis treatment outcomes.

The pandemic of COVID‐19 is a global challenge for health care and dermatologists are not standing apart from trying to meet this challenge. The European Academy of Dermatology and Venereology (EADV) has collected recommendations from its Task Forces (TFs) related to COVID‐19. The Journal of the EADV has established a COVID‐19 Special Forum giving free access to related articles. The psychosocial effects of the pandemic, an increase in contact dermatitis and several other skin diseases because of stress, disinfectants and protective equipment use, especially in health care workers, the temporary limited access to dermatologic care, the dilemma whether or not to pause immunosuppressive therapy, and, finally, the occurrence of skin lesions in patients infected by COVID‐19 all contribute to significant quality of life (QoL) impairment. Here we present detailed recommendations of the EADV TF on QoL and Patient Oriented Outcomes on how to improve QoL in dermatologic patients during the COVID‐19 pandemic for several different groups of patients and for the general population.

Background Anti‐tumour necrosis factor (TNF) and anti‐interleukin (IL)‐12/23 biologics revolutionized plaque psoriasis treatment by enabling ≥75% improvement in the Psoriasis Area and Severity Index (PASI 75) in clinical trials. Modern biologics are now reported to achieve PASI 100 (complete skin clearance) in clinical trials. However, real‐world evidence of skin clearance rates with biologics is limited. PSO‐BIO‐REAL was conducted to understand the real‐world burden of plaque psoriasis. Objective The primary objective of this observational study was to estimate the proportion of patients who achieved complete skin clearance at 6 months. Secondary objectives included maintenance of response and evaluation of complete skin clearance at 12 months. Methods PSO‐BIO‐REAL was a multinational, prospective, real‐world, non‐interventional study of skin clearance and patient‐reported outcomes (PROs) with biologics. A total of 846 patients from the United States (32%), France (28%), Italy (22%), the United Kingdom (11%) and Germany (8%) were enrolled and followed for one year. Eligible patients were aged ≥18 years with moderate‐to‐severe plaque psoriasis who had initiated a biologic for plaque psoriasis. Patients could be biologic‐naïve or switching biologics (biologic‐experienced). Assessments were made at baseline and at months 6 and 12. Results At 6 and 12 months, 23% and 26% of patients achieved complete skin clearance, respectively. Prior to study entry, 60% were biologic‐naïve. The proportion of patients achieving complete skin clearance was lower among biologic‐experienced patients (20% at both months 6 and 12) compared with biologic‐naïve patients (25% at month 6, 30% at month 12). The rate of complete skin clearance decreased as the number of prior biologics and baseline comorbidities increased. Conclusion Only one in four patients achieved complete skin clearance after 6 months of treatment with biologics. The study indicates there still is an unmet need for more efficacious biologics for patients with psoriasis.

The overall objective of the guideline is to provide up-to-date, evidence-based recommendations for the management of urticaria. The document aims to: offer an appraisal of all relevant literature up to March 2020, focusing on any key developments address important, practical clinical questions relating to the primary guideline objective provide guideline recommendations and if appropriate research recommendations The guideline is presented as a detailed review with highlighted recommendations for practical use in primary, secondary and tertiary care, in addition to an updated Patient Information Leaflet (PIL; available on the BAD Skin Health Information website, https://www.skinhealthinfo.org.uk/a-z-conditions-treatments/).

Background: Nonattendance is common among patients suffering from delusional infestation (DI) with a risk factor for poorer patient outcomes. Objective: The aim of this study was to determine the incidence rate and predictors of nonattendance among patients presenting to a psychodermatology department with DI and the subsequent effect on the success of prescribing new antipsychotics. Methods: Data of 265 patients were reviewed of the Amsterdam UMC, the Erasmus University Medical Center, the Royal London Hospital, and the Liverpool School of Tropical Medicine between January 2008 and October 2019. Results: We observed that among the patients who attended the first consultation, 57% (n = 144) did not attend their second visit. Recreational drug use was significantly higher in the nonattendance group compared to the attendance group (25% against 18%). Patients who had a history of previously prescribed antipsychotics at the time of the first consultation were less likely to get prescribed antipsychotics from the psychodermatology departments for DI; however, prescribing antipsychotic drugs by the psychodermatology department did not influence nonattendance significantly. Conclusions: People suffering from DI are at high risk of nonattendance, even in specialist settings. Patients with current illicit drug use and younger patients are particularly at risk of this.

Background: Physician-reported clinical outcome and quality of life (QoL) measures are currently used to assess outcomes and direct treatment of plaque psoriasis. However, people with psoriasis may have different criteria for judging treatment success. Objectives: To build a unified consensus on the definition of ‘freedom from disease’ from a European stakeholder group, including people with psoriasis, dermatologists and nurses. Methods: The modified Delphi consensus methodology was used to define ‘freedom from disease’, with a consensus group consisting of people with psoriasis, nurses and dermatologists. This methodology involved people with psoriasis during the entire process and consisted of a 15-member Facilitating Consensus Panel to drive the programme content and a larger Voting Consensus Panel to vote on defining ‘freedom from disease’. The Facilitating Panel agreed on disease domains, and aspects of each domain were put forward to the Voting Consensus Panel to establish relative importance. Following two voting rounds, a meeting was held to agree on a final consensus statement. Results: The Facilitating Panel consisted of six patient advocacy group representatives, three specialist nurses and six dermatologists. Voting rounds 1 and 2 were completed by 166 and 130 respondents from the Voting Consensus Panel, respectively. The outputs from both rounds of voting were similar, focusing on normality of living, symptom control, and a relationship of mutual respect and trust between the individual with psoriasis and their healthcare professional. The consensus statement emphasizes that ‘freedom from disease’ is multifaceted and includes the following domains ‘management of clinical symptoms’, ‘psychosocial elements’, ‘QoL and well-being’, ‘treatment’ and ‘healthcare team support’. ‘Freedom from disease’ means all aspects are addressed. Conclusions: Freedom from disease in psoriasis is a multicomponent concept including five main domains. This diverse and multifaceted patient perspective will help us to improve understanding of the outcomes of treatment interventions in people with psoriasis.

IntroductionIchthyoses comprise a heterogenous group of rare genetic skin disorders that involves the entire skin surface, often with additional syndromic features, and pose many clinical challenges. Without curative intervention, the mainstay of life-long symptom management is supportive in nature and can remain the responsibility of the caregiver. Although impact on the wider family is considered an important outcome of policies and services, there is a lack of caregiver consensus on what outcome domains to measure to fully assess the impact of ichthyosis on the patient and the caregiver. This project aims to identify a set of core outcome domains towards a core outcome set for ichthyosis that can measure all relevant concepts of ichthyosis in clinical practice, service delivery and research.Methods and analysisFollowing the COMET (Core Outcome Measures in Effectiveness Trials) initiative, this project will employ a mixed-method study design which was developed using public and patient involvement and an international multidisciplinary expert group (clinical experts, patients and their representatives, policymakers, researchers and service providers). Experts by experience, or caregivers, will be recruited through online ichthyosis support groups. Phase one will focus on item generation and involve: (1) a systematic literature review, (2) a multimethods international qualitative study with ichthyosis caregivers and (3) co-development of items for an e-survey. Phase two, item refinement, will employ a novel four-pronged consensus approach: (1) an e-Delphi survey, (2) statistical analysis of e-Delphi survey results, (3) online qualitative feedback and (4) an online consensus discussion. All methodological considerations will be clearly linked with each Core Outcome Set-STAndards for Developing recommendation.Ethics and disseminationResearch Ethics Committee approval obtained from the School of Psychology, Ulster University (UK)(Ref:REC/20/0004). Results will be presented in published international peer-reviewed journals, at scientific meetings and support groups.RegistrationCOMET database (January 2019).

Psoriasis is a common chronic, systemic inflammatory disease, affecting approximately 2% of the population worldwide. Psoriasis is associated with profound psychosocial comorbidity with a burden that extends well beyond the physical signs and symptoms. Psychosocial comorbidities strongly associated with psoriasis include anxiety and depression, suicidal ideation, and substance misuse. There is a substantial unmet need for access to psychological support for people with skin disease in the UK. Recent reports found that while up to 98% of patients felt that their skin disease had affected their emotional or psychological well-being, only 18% sought help. This care gap is largely due to a lack of awareness about the limited available services alongside poor recognition, diagnosis, and triaging. Addressing psychosocial support needs starts with early identification, which can be complex and challenging. Once patients who need further support are identified, outcomes can be improved through prompt and effective treatment of inflammation, cognitive behavioural therapy, meditation and mindfulness-based therapy (including motivational interviewing), and to some extent psychotropic medication. Finally, resources for mental health support are notoriously limited, with dire consequences for patients. It is imperative that a proportion of the new funding promised for mental health services is bookmarked for dermatology patients and adequate provision of multidisciplinary psychodermatology teams to best serve the needs of this population. Ultimately, psoriasis is a complex condition with multifactorial psychological and biological drivers. Psoriasis is associated with high levels of distress, which is often under-recognized. Fully addressing this condition requires a holistic approach to the physical and psychosocial aspects to maximise adherence, efficacy, and optimise patient quality of life.

Core outcome sets (COSs) are an agreed standardized collection of outcomes that should be measured and reported in all clinical trials for a specific clinical condition. Tsekhe aim of our position paper by the European Academy of Dermatology and Venereology (EADV) Task Force on Quality of Life and Patient Oriented Outcomes was to identify the challenges and Patient Oriented Outcomes advantages in the development of COSs within dermatological QoL research. Twelve EADV Task Force multidisciplinary team members presented a total of 101 items (51 advantages and 50 disadvantages). All participants considered that COS are beneficial for comparison between different studies, treatments, dermatological diseases, geographical location and ethnicities. In conclusion, the EADV Task Force on Quality of Life and Patient Oriented Outcomes has recognized the primacy of advantages of COS and deliberated that the disadvantages in COS are related to development process and use of COS.