Skin Pathology Assessment With Optical Technologies

NCT04295824 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2024-05-06

No results posted yet for this study

Summary

The Skin Pathology assessment with Optical Technologies (SPOT) study aims to assess the feasibility of recently developed light-based skin imaging tools such as Optical Coherence Tomography (OCT) for the study of eczema (dermatitis \[AD\]).

Tools such as OCT have enabled us to see beneath the skin surface, allowing us to see changes in our skin which are hidden and impossible to assess by eye, simply by shining harmless light into the skin. The investigators want to understand what these changes represent in the broader context of eczema.

To do this, the investigators would like to recruit 60 volunteers who have a range of different eczema severities. The investigators would also like to recruit 20 healthy volunteers, who have never suffered from eczema. All volunteers would be aged between 11 and 60.

The study is based at the Royal Hallamshire Hospital in Sheffield, with consent and sample-collection taking place at either the hospital's Clinical Research Facility or the Sheffield Children's Hospital. The study consists of a single main visit, which is expected to take approximately 3 hours, and a short follow up visit 2-4 weeks later.

During the main study visit, the investigators will collect a range of measurements from the inner elbows and cheeks using harmless topical probes (Including OCT). These measurements include information about the skin's layers, blood flow, composition, water loss, acidity and redness. The investigators will also collect some samples, including tape-strips, a saliva sample and blood samples. For adult participants the investigators will also collect 2-4 skin biopsies from the inner elbows, which involves removing small pieces of skin under a local anaesthetic.

It is our hope that by demonstrating the advantages of new harmless imaging techniques, the investigators can reduce the need for invasive procedures in the future. Long term, this may help us to improve the way healthcare professionals monitor and treat eczema.

Conditions

  • Atopic Dermatitis Eczema

Interventions

DIAGNOSTIC_TEST

Skin imaging and Skin biopsy

Imaging includes: * Structural Optical Coherence Tomography (OCT) - Skin thickness/roughness. * Angiographic OCT- Vessel depth/morphology. * Polarisation-sensitive OCT - Tissue birefringence / collagen index. * Skin biopsies will be taken from the same volar forearm site as the imaging is performed.

Sponsors & Collaborators

  • University of Sheffield

    collaborator OTHER
  • Sheffield Children's NHS Foundation Trust

    collaborator OTHER
  • Sheffield Teaching Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Michael J Cork, MD+PhD · University of Sheffield & Sheffield Teaching Hospitals

  • Simon G Danby, PhD · University of Sheffield

Eligibility

Min Age
11 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-06
Primary Completion
2022-07-29
Completion
2022-07-29

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04295824 on ClinicalTrials.gov