[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658005":3},{"organization":4,"outcomesModule":7,"designInfo":51,"detailedDescription":54,"studyPopulation":55,"armGroups":56,"interventions":62,"overallOfficials":68,"centralContacts":72,"locations":82,"responsibleParty":100,"collaborators":102,"id":108,"slug":109,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":52,"eligibilityCriteria":113,"healthyVolunteers":110,"sex":114,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":52,"studyType":120,"phases":52,"briefSummary":121,"conditions":122,"keywords":125,"overallStatus":131,"whyStopped":52,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"University of Edinburgh","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":26,"otherOutcomes":34},[9,13,16,20,23],{"measure":10,"description":11,"timeFrame":12},"Change from baseline in HVAS shear viscosity parameters","Shear viscosity (SV, in Pa·s) values of epidermis (SVE) and dermis (SVD), measured by the HVAS.\n\nChange from baseline (week 0) in each parameter is calculated as percentage for each participant at each weekly visit.","Weekly, for 10 weeks",{"measure":14,"description":15,"timeFrame":12},"Change from baseline in HVAS shear elasticity parameters","Shear elasticity (SE, in Pa) values of epidermis (SEE) and dermis (SED), measured by the HVAS.\n\nChange from baseline (week 0) in each parameter is calculated as percentage for each participant at each weekly visit.",{"measure":17,"description":18,"timeFrame":19},"Change from baseline in dermatologist-assessed PASI score","Change from baseline in dermatologist-assessed Psoriasis Area and Severity Index (PASI) for psoriasis participants (score range 0-72)\n\nChange from baseline (week 0) is calculated as percentage for each participant at each visit.\n\nWeeks 0, 2, 4, 6, 8, 10","Weeks 0, 2, 4, 6, 8, 10",{"measure":21,"description":22,"timeFrame":19},"Change from baseline in dermatologist-assessed EASI score","Change from baseline in dermatologist-assessed Eczema Area and Severity Index (EASI) for eczema participants (score range 0-72). Change from baseline (week 0) is calculated as percentage for each participant at each visit. Weeks 0, 2, 4, 6, 8, 10",{"measure":24,"description":25,"timeFrame":19},"Correlation between changes in HVAS biomechanical parameters and clinical severity scores changes","Kendall's tau-b correlation coefficient (95% CI) between change from baseline in HVAS parameters (SVE, SVD, SEE, SED) and change from baseline in clinical severity score (EASI or PASI). Each HVAS parameter analysed separately across matched timepoints.",[27,30],{"measure":28,"description":29,"timeFrame":12},"Within participant ratios (affected vs healthy skin) for each HVAS parameter","Within-participant dimensionless ratio for each HVAS parameter (SVE, SVD, SEE, SED) calculated as: affected skin divided by adjacent healthy skin (e.g., SVE\\_ratio = SVE\\_affected \u002F SVE\\_healthy).",{"measure":31,"description":32,"timeFrame":33},"Incidence of device-related adverse events","Incidence proportion (% participants) and severity (mild\u002Fmoderate\u002Fsevere) of device-related discomfort, transient skin irritation, Serious Adverse Events (SAE), and Serious Adverse Device Effects (SADE). Upper limit of 95% CI reported for SAE\u002FSADE rates.","Weekly for 10 weeks",[35,39,42,45,48],{"measure":36,"description":37,"timeFrame":38},"Participant-reported experience and acceptability of investigational procedures","Semi-structured qualitative interviews on participant experience of eczema\u002Fpsoriasis and acceptability of vibroacoustic sensor measurements and skin assessments.\n\nThematic analysis to identify themes on acceptability, perceived burden, and perceived value.","At week 1 and 9",{"measure":40,"description":41,"timeFrame":12},"Skin photographs","Optional non-identifiable photographic images of the test sites will be collected.",{"measure":43,"description":44,"timeFrame":12},"Skin Surface temperature measurements","Skin surface temperature (infra-red thermometry, °C) at affected and adjacent healthy sites. This will be measured separately for each skin site at each study visit.",{"measure":46,"description":47,"timeFrame":12},"Skin thickness measurements","Epidermal and dermal thickness (OCT, µm) at affected and adjacent healthy sites. Each measurement will be summarised separately for each skin site at each study visit.",{"measure":49,"description":50,"timeFrame":12},"Skin colour measurements","Quantitative structural and physiological skin measurements Skin colour (L\\*a\\*b colourimetry) at affected and adjacent healthy sites. Each measurement will be summarised separately for each skin site at each study visit.",{"allocation":52,"interventionModel":52,"interventionModelDescription":52,"primaryPurpose":52,"observationalModel":6,"timePerspective":53,"maskingInfo":52},null,"PROSPECTIVE","Over 300 million people worldwide suffer from Inflammatory Skin Diseases (ISDs) like eczema and psoriasis, experiencing chronic discomfort, pain and psychosocial challenges. Current treatment follows a stepwise approach depending on severity, starting with topical agents, then progressing to phototherapy, conventional systemic drugs, and finally modern, highly targeted (and highly expensive) agents.\n\nProgress up this therapeutic ladder is based on a combination of subjective scores provided by patients, and relatively objective scores from dermatologists. While generally reproducible, skin assessment is notoriously unreliable when assessing features such as erythema in darker skin types. The rate limiting step for patients being treated for ISDs is access to clinicians for assessment of disease response. A lack of objective measures of ISDs means that each stage of treatment requires visual skin assessment, which is time consuming and creates a major bottleneck in care delivery, leading to long wait times (with an average 54-week wait for urgent dermatology in the NHS Lothian alone and 145-week for routine appointments), and increased public healthcare costs (NHS spends £179 million\u002Fyear for mild-moderate eczema).\n\nAddressing these challenges, our goal is to introduce an objective measurement device to clinical and non-clinical environments where data-driven care can improve patient pathways. From a management perspective, increased understanding of how skin responds to therapy will enable more precise and efficient strategies, reducing time and costs while helping identify which patients are most likely to benefit from specific treatments or interventions.\n\nThus, the technology that the investigators are seeking to progress is a vibroacoustic sensor which measures the material properties of skin's layers using small vibrations on the surface of the skin. Crucially, our innovation is the ability to measure the elasticity (stiffness) and viscoelasticity (fluid content) of the epidermis, dermis and hypodermis of the skin (its key constituent layers) at high resolution from the surface of the skin (i.e. non-invasively). Our acoustic technology avoids the biases that can be common in optical or visual methods of skin assessment of darker skin as the acoustic properties are pigment independent.\n\nFor inflammatory skin disease - and eczema and psoriasis in particular - the investigators want to measure epidermal and dermal changes as indicators of skin condition. Whilst the investigators have an early assessment of an eczema sufferer, they lack sufficient feasibility data that would justify larger scale investment in a clinical trial. Thus, within the current project they plan to test whether there are correlates between expert dermatologist skin assessment and the material metrics from our sensors. A strong correlation would indicate the potential for dermatologist-quality measures to be taken outside of a specialist centre thereby allowing treatment tracking, community treatment assessments and diagnostic confirmations, which would reduce wait times for patients.\n\nOur tests for this will be on up to twenty patients who are undergoing third\u002Ffourth-line treatments for different severity degrees of eczema and psoriasis, over a period of 12 weeks. This help us to understand (1) if our measurements provide beneficial and appropriate data for clinicians to help understand treatment response; (2) what perspectives are of patients having measurements taken; and (3) what methods are clinically acceptable. Gathering this data will position us to justify larger scale investment in clinical trials of our technology.","Patients with eczema or psoriasis being treated in the dermatology outpatient department.",[57],{"label":58,"type":52,"description":59,"interventionNames":60},"Study participants - all","This group will be the only group in the study as this is a comparator between device and clinician",[61],"Device: Vibroacoustic sensing device",[63],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":52},"DEVICE","Vibroacoustic sensing device","there is only one primary test device",[58],[69],{"name":70,"affiliation":5,"role":71},"Richard B Weller","PRINCIPAL_INVESTIGATOR",[73,78],{"name":74,"role":75,"phone":76,"phoneExt":52,"email":77},"Richard B Weller, MB BS MD","CONTACT","+441315362041","richard.weller@ed.ac.uk",{"name":79,"role":75,"phone":80,"phoneExt":52,"email":81},"Michael Crichton, PhD","+441314514367","m.crichton@hw.ac.uk",[83],{"facility":84,"status":52,"city":85,"state":86,"zip":87,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":95,"contacts":96},"Lauriston Building","Edinburgh","Edinburgh, City of","EH3 9EN","United Kingdom","UK",{"type":91,"coordinates":92},"Point",[93,94],-3.19648,55.95206,{"lat":94,"lon":93},[97],{"name":98,"role":75,"phone":52,"phoneExt":52,"email":99},"Richard Weller, MB BS MD","r.weller@ed.ac.uk",{"type":101,"investigatorFullName":52,"investigatorTitle":52,"investigatorAffiliation":52,"oldNameTitle":52,"oldOrganization":52},"SPONSOR",[103,106],{"name":104,"class":105},"NHS Lothian","OTHER_GOV",{"name":107,"class":6},"Heriot-Watt University","100658005","evidencing-vibroacoustic-sensing-for-inflammatory-skin-disease-monitoring-100658005",false,"NCT07846813","Evidencing Vibroacoustic Sensing for Inflammatory Skin Disease Monitoring","Inclusion Criteria:\n\n* Over 18 and under 75 years old.\n* Able to give informed consent.\n* Diagnosed with a moderate or severe inflammatory skin condition (in particular, eczema or psoriasis).\n* Scheduled to begin phototherapy within the next 21 days.\n* Able to attend the clinic for their weekly treatment sessions.\n* No known hypersensitivity to the material that will come into contact with skin during the study (i.e., Parylene-C).\n* Where there is childbearing potential , willing to use effective contraception throughout the study.\n\nExclusion Criteria:\n\n* Age below 18 or over 75\n* Unable to provide informed consent.\n* Patients with comorbidities or conditions that might slow down healing or confound measurements at this stage (e.g., diabetes, immunosuppressed, on blood thinning medication, with extensive scarring, or pregnant).\n* Patients whose phototherapy treatment has already started.\n* Patients with known hypersensitivity to the material that will come into contact with skin during the study (i.e., Parylene-C).\n* Patients who are not willing to use contraception throughout the study and are of childbearing potential.","ALL","18 Years","75 Years",{"count":118,"type":119},20,"ESTIMATED","OBSERVATIONAL","Over 300 million people around the world struggle with skin conditions like eczema and psoriasis, which cause ongoing discomfort and emotional stress. In the UK, these conditions are diagnosed by doctors looking at the skin to assess the severity of the disease, but delays in seeing specialists contribute to long waiting times in the NHS. To tackle these problems, the investigators have created a device that safely uses sound waves to measure skin properties, like stiffness and moisture. Unlike just looking, this device gives clear, data-based insights into skin health, which the investigators hope will enable us to accurately measure disease severity without the need to wait for a dermatologist appointment. This should speed up specialist referrals and allow us to tailor treatment options more effectively, earlier on.\n\nIn our study, we want to prove that these sound wave measurements match up with disease severity and treatment success in eczema and psoriasis cases. We'll compare the results with those from dermatologists.\n\nWe are looking for 20 volunteers with eczema or psoriasis who are about to start treatment. Volunteers will be scanned with our device alongside their regular skin examinations. We'll gather some extra information through questions and photos (optional), but no additional treatments or painful procedures are involved.",[123,124],"Eczema","Psoriasis",[126,127,128,129,130],"dermatology","skin","sensor","acoustic","elasticity","NOT_YET_RECRUITING","2026-09-22",{"date":134,"type":135},"2026-09-29","ACTUAL",{"date":137,"type":119},"2026-10-01",{"date":139,"type":119},"2026-12-31",{"name":5,"class":6},1]