CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 80 enrolled
Drug / intervention
Skin imaging and Skin biopsyother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04295824
NCT04295824N/ACompleted

Skin Pathology Assessment With Optical Technologies (SPOT): a Cross- Sectional Clinical Study in Atopic Dermatitis Patients and Healthy Subjects

Sheffield Teaching Hospitals NHS Foundation Trust·observational·Posted Mar 5, 2020·Updated May 6, 2024

In Brief

An observational study evaluating Skin imaging and Skin biopsy for Atopic Dermatitis Eczema. Completed, enrolled 80 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMar 5, 2020
Enrollment StartAug 6, 2020
Primary CompletionJul 29, 2022
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 6.3 years ago

Interventions

Skin imaging and Skin biopsyother

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.