About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Patients with eczema or psoriasis being treated in the dermatology outpatient department.
Trial design
Other
Prospective
Treatments tested in this trial
Vibroacoustic sensing device
Devicethere is only one primary test device
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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
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
Secondary outcomes
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).
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.
Other outcomes
Participant-reported experience and acceptability of investigational procedures
Semi-structured qualitative interviews on participant experience of eczema/psoriasis and acceptability of vibroacoustic sensor measurements and skin assessments. Thematic analysis to identify themes on acceptability, perceived burden, and perceived value.
Skin photographs
Optional non-identifiable photographic images of the test sites will be collected.
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.
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: