EczemaNCT07846813
Evidencing Vibroacoustic Sensing for Inflammatory Skin Disease Monitoring
An observational study of Eczema and Psoriasis, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- Vibroacoustic sensing device
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with eczema or psoriasis being treated in the dermatology outpatient department.
Who may be able to join
- Over 18 and under 75 years old.
- Able to give informed consent.
- Diagnosed with a moderate or severe inflammatory skin condition (in particular, eczema or psoriasis).
- Scheduled to begin phototherapy within the next 21 days.
- Able to attend the clinic for their weekly treatment sessions.
- No known hypersensitivity to the material that will come into contact with skin during the study (i.e., Parylene-C).
- Where there is childbearing potential , willing to use effective contraception throughout the study.
Who cannot join
- Age below 18 or over 75
- Unable to provide informed consent.
- 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).
- Patients whose phototherapy treatment has already started.
- Patients with known hypersensitivity to the material that will come into contact with skin during the study (i.e., Parylene-C).
- Patients who are not willing to use contraception throughout the study and are of childbearing potential.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Lauriston Building
Edinburgh, Edinburgh, City of, EH3 9EN
Richard Weller, MB BS MD, r.weller@ed.ac.uk
About this study
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.
In 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.
We 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.
Read the detailed description
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.
Progress 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/year for mild-moderate eczema).
Addressing 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.
Thus, 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.
For 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.
Our tests for this will be on up to twenty patients who are undergoing third/fourth-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.
- Being tested
- Vibroacoustic sensing device
- Keywords
- dermatology, skin, sensor, acoustic, elasticity
- Medical subject headings
- Eczema, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibroacoustic sensing deviceDevice
there is only one primary test device
| Study group | Role | What they receive |
|---|---|---|
| Study participants - all | This group will be the only group in the study as this is a comparator between device and clinician Receives: Device: Vibroacoustic sensing device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Change from baseline (week 0) in each parameter is calculated as percentage for each participant at each weekly visit.
Measured: Weekly, for 10 weeks
Change from baseline in HVAS shear elasticity parameters
Shear elasticity (SE, in Pa) values of epidermis (SEE) and dermis (SED), measured by the HVAS.
Change from baseline (week 0) in each parameter is calculated as percentage for each participant at each weekly visit.
Measured: Weekly, for 10 weeks
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)
Change from baseline (week 0) is calculated as percentage for each participant at each visit.
Weeks 0, 2, 4, 6, 8, 10
Measured: Weeks 0, 2, 4, 6, 8, 10
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
Measured: Weeks 0, 2, 4, 6, 8, 10
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.
Measured: Weeks 0, 2, 4, 6, 8, 10
Secondary outcomes (2)
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 / SVE_healthy).
Measured: Weekly, for 10 weeks
Incidence of device-related adverse events
Incidence proportion (% participants) and severity (mild/moderate/severe) 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/SADE rates.
Measured: Weekly for 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EczemaStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian, Heriot-Watt University
- Responsible party
- Sponsor
- Investigators
- Richard B Weller, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846813
- Sponsor's protocol ID
- UEdinburgh AC26032
- Status last verified
- Sep 2026
- First submitted
- 28 Apr 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data following publication.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidencing Vibroacoustic Sensing for Inflammatory Skin Disease Monitoring
- ClinicalTrials.gov ID
- NCT07846813
- Acronym / sponsor ID
- UEdinburgh AC26032
- Keywords
- dermatology, skin, sensor, acoustic, elasticity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian, Heriot-Watt University
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
In 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.
We 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.
Detailed description
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.
Progress 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/year for mild-moderate eczema).
Addressing 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.
Thus, 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.
For 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.
Our tests for this will be on up to twenty patients who are undergoing third/fourth-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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study participants - all | – | Device: Vibroacoustic sensing deviceThis group will be the only group in the study as this is a comparator between device and clinician |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with eczema or psoriasis being treated in the dermatology outpatient department.
Key inclusion criteria (7 listed)
- Over 18 and under 75 years old.
- Able to give informed consent.
- Diagnosed with a moderate or severe inflammatory skin condition (in particular, eczema or psoriasis).
- Scheduled to begin phototherapy within the next 21 days.
- Able to attend the clinic for their weekly treatment sessions.
Key exclusion criteria (6 listed)
- Age below 18 or over 75
- Unable to provide informed consent.
- 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).
- Patients whose phototherapy treatment has already started.
- Patients with known hypersensitivity to the material that will come into contact with skin during the study (i.e., Parylene-C).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibroacoustic sensing devicethere is only one primary test device | Device | Study participants - all |
Primary outcome
Change from baseline in HVAS shear viscosity parameters
Time frame: Weekly, for 10 weeks
Shear viscosity (SV, in Pa·s) values of epidermis (SVE) and dermis (SVD), measured by the HVAS. Change from baseline (week 0) in each parameter is calculated as percentage for each participant at each weekly visit.
Change from baseline in HVAS shear elasticity parameters
Time frame: Weekly, for 10 weeks
Shear elasticity (SE, in Pa) values of epidermis (SEE) and dermis (SED), measured by the HVAS. Change from baseline (week 0) in each parameter is calculated as percentage for each participant at each weekly visit.
Change from baseline in dermatologist-assessed PASI score
Time frame: Weeks 0, 2, 4, 6, 8, 10
Change from baseline in dermatologist-assessed Psoriasis Area and Severity Index (PASI) for psoriasis 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
Change from baseline in dermatologist-assessed EASI score
Time frame: Weeks 0, 2, 4, 6, 8, 10
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
Correlation between changes in HVAS biomechanical parameters and clinical severity scores changes
Time frame: Weeks 0, 2, 4, 6, 8, 10
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.
2 secondary outcomes
Within participant ratios (affected vs healthy skin) for each HVAS parameter
Time frame: Weekly, for 10 weeks
Incidence of device-related adverse events
Time frame: Weekly for 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Yes. Anonymised data following publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard B Weller principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eczema and Psoriasis, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Richard B Weller, MB BS MD (+441315362041, richard.weller@ed.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in HVAS shear viscosity parameters (time frame: Weekly, for 10 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.