跳至主要内容
临床试验/NCT07846813
NCT07846813尚未招募不适用

Evidencing Vibroacoustic Sensing for Inflammatory Skin Disease Monitoring

University of Edinburgh1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
试验地点
1
主要终点
Change from baseline in HVAS shear viscosity parameters

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Study participants - all

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

干预措施: Vibroacoustic sensing device (Device)

结局指标

主要结局

Change from baseline in HVAS shear viscosity parameters

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验