Evidencing Vibroacoustic Sensing for Inflammatory Skin Disease Monitoring

NCT07846813 | Not Yet Recruiting

• 1 other identifier: UEdinburgh AC26032
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Eczema; Psoriasis

Keywords

dermatology; skin; sensor; acoustic; elasticity

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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

  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

  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.

  Weeks 0, 2, 4, 6, 8, 10

Secondary Outcomes (2)

• Within participant ratios (affected vs healthy skin) for each HVAS parameter

  Weekly, for 10 weeks

• Incidence of device-related adverse events

  Weekly for 10 weeks

Other Outcomes (5)

• Participant-reported experience and acceptability of investigational procedures

  At week 1 and 9

• Skin photographs

  Weekly, for 10 weeks

• Skin Surface temperature measurements

  Weekly, for 10 weeks

Study Arms (1)

Study participants - all

This group will be the only group in the study as this is a comparator between device and clinician

Device: Vibroacoustic sensing device

Interventions

Vibroacoustic sensing device DEVICE

there is only one primary test device

Study participants - all

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with eczema or psoriasis being treated in the dermatology outpatient department.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heriot-Watt University: collaborator
• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (1)

Lauriston Building

Edinburgh, Edinburgh, City of, EH3 9EN, United Kingdom

Location

MeSH Terms

Conditions

Eczema; Psoriasis

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Skin Diseases, Papulosquamous

Study Officials

• Richard B Weller

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard B Weller, MB BS MD

CONTACT

+441315362041; richard.weller@ed.ac.uk

Michael Crichton, PhD

CONTACT

+441314514367; m.crichton@hw.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: September 29, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Following publication and subject to request for additional data related to the study. End date is not restricted at present.
• Access Criteria: Publication data will be available on request following publication. Raw data will be accessible by other researchers subject to our data management and sharing plan.

Locations

GB (1)