Status:
COMPLETED
Skin Pathology Assessment With Optical Technologies
Lead Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborating Sponsors:
University of Sheffield
Sheffield Children's NHS Foundation Trust
Conditions:
Atopic Dermatitis Eczema
Eligibility:
All Genders
11-60 years
Brief 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 ...
Detailed Description
A total of 80 participants will be recruited for the study spread equally across 4 cohorts, those with healthy skin, and those with a mild/moderate/severe eczema/dermatitis \[AD\] lesion on their inne...
Eligibility Criteria
Inclusion
- Healthy subjects and AD patients
- Male or female
- Aged between 11-60 years
- Volunteer understands the purpose, modalities and potential risk of the trial
- Volunteers able to read and understand English
- Volunteers willing to sign the informed consent
- AD patients:
- Volunteers with AD defined according to the UK working party diagnostic criteria
- Must have an AD lesion present at either the right or left forearm (Proximal end).
- For 10 participants in each AD group: visible AD lesion present on either the right or left cheek.
- For 10 participants in each AD group: Global severity score (EASI) that matches their cohort allocation (Mild/Moderate/Severe).
- According to the UK working party diagnostic criteria, eczema is defined as exhibiting an itchy skin condition plus 3 or more of:
- History of involvement of the skin creases
- Personal history of asthma or hay fever
- History of generally dry skin in past year
- Visible flexural dermatitis
- Onset below age 2
- Instructions to participants 1. Do not ingest caffeine (e.g Coffee) or take anti-inflammatory drugs (e.g Ibuprofen) on the imaging day (until after imaging).
Exclusion
- Treatment with the following medications within 4 weeks: systemic immunosuppressive/immunomodulating drugs (e.g. methotrexate, cyclosporine, azathioprine, mycophenolate-mofetil, Janus kinase inhibitors, etc.), systemic corticosteroids.
- Three or more bleach baths during any week within 4 weeks.
- Treatment with biologics within 5 half-lives (if known) or 12 weeks.
- Treatment with the following medications within 2 weeks if mild/moderate global severity or 1 week if severe global severity: topical corticosteroids, topical calcineurin inhibitors.
- Treatment with any topical leave-on product on the test areas 7 days prior to participation if healthy/mild and 24 hours prior to participation if moderate/severe global severity.
- Volunteers with acne, suntan, birth marks, multiple nevi, tattoos, blemishes or dense body hair that obstruct the test areas.
- Volunteers with a condition that in the opinion of the investigator contradicts participation in the study.
- Volunteer is incapable of giving fully informed consent.
- Volunteers judged by the PI to be inappropriate for the trial.
Key Trial Info
Start Date :
August 6 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 29 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04295824
Start Date
August 6 2020
End Date
July 29 2022
Last Update
May 6 2024
Active Locations (1)
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1
Sheffield Dermatology Research, University of Sheffield Medical School, The Royal Hallamshire Hospital
Sheffield, South Yorkshire, United Kingdom, S10 2JF