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Skin Pathology Assessment With Optical Technologies (SPOT)

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ClinicalTrials.gov Identifier: NCT04295824
Recruitment Status : Not yet recruiting
First Posted : March 5, 2020
Last Update Posted : March 5, 2020
Sponsor:
Collaborators:
University of Sheffield
Sheffield Children's NHS Foundation Trust
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

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 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.


Condition or disease Intervention/treatment
Atopic Dermatitis Eczema Diagnostic Test: Skin imaging and Skin biopsy

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Skin Pathology Assessment With Optical Technologies (SPOT): a Cross- Sectional Clinical Study in Atopic Dermatitis Patients and Healthy Subjects
Estimated Study Start Date : March 2, 2020
Estimated Primary Completion Date : May 3, 2021
Estimated Study Completion Date : July 5, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Eczema Rashes

Group/Cohort Intervention/treatment
Mild AD
20 subjects with mild local AD on their volar forearm (At least 10 with lesions on the face | At least 10 which are globally mild).
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.

Moderate AD
20 subjects with moderate local AD on their volar forearm (At least 10 with lesions on the face | At least 10 which are globally moderate).
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.

Severe AD
20 subjects with severe local AD on their volar forearm (At least 10 with lesions on the face | At least 10 which are globally severe).
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.

Healthy
20 healthy volunteers
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.




Primary Outcome Measures :
  1. Local clinical severity [ Time Frame: baseline visit 1 ]
    Primary endpoint: Local clinical severity (erythema, papulation, excoriation and lichenification) of test skin sites


Secondary Outcome Measures :
  1. Skin epidermal thickness [ Time Frame: baseline visit 1 ]
    Inflammation associated endpoint using Vivosight OCT system

  2. Skin vascular plexus depth [ Time Frame: baseline visit 1 ]
    Inflammation associated endpoint using Vivosight OCT system

  3. Skin vascular density/diameter [ Time Frame: baseline visit 1 ]
    Inflammation associated endpoint using Vivosight OCT system

  4. Skin collagen index [ Time Frame: baseline visit 1 ]
    Inflammation associated endpoint using PS-OCT system

  5. Skin surface roughness [ Time Frame: baseline visit 1 ]
    Inflammation associated endpoint using Vivosight OCT system

  6. Epidermal layer scattering [ Time Frame: baseline visit 1 ]
    Inflammation associated endpoint putatively relating to tissue remodelling using Vivosight OCT system

  7. Erythema index [ Time Frame: baseline visit 1 ]
    Inflammation associated endpoint using c-cube images of skin lesions

  8. Stratum corneum structure [ Time Frame: baseline visit 1 ]
    Skin barrier associated endpoint using (ATR-FTIR) spectroscopy

  9. Protease activity [ Time Frame: baseline visit 1 ]
    Skin barrier associated endpoint, Ex vivo, using superficial stratum corneum samples collected on D-Squame tape discs


Biospecimen Retention:   Samples With DNA
Saliva sample (buccal swab) for FLG genotyping. Superficial stratum corneum sample collection by tape-stripping: For determination of protease activity ex vivo and determination of natural moisturizing factor (NMF) levels by HPLC. FibroTX SELF samples will be collected from the designated skin sites using a transdermal patch system to collect secreted and diffusible regulatory molecules directly from the skin surface according to the manufacturer's instructions. Using this system multiple analytes can be measured, including for example CXCL1, IL-1A, CCL27, and hBD2. Blood samples will be collected for future study of cytokine levels in relationship to the structural changes observed within the skin. Skin Biopsies


Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patient with atopic dermatitis/atopic eczema and Healthy Controls
Criteria

Inclusion Criteria:

Healthy subjects and AD patients

  1. Male or female
  2. Aged between 11-60 years
  3. Volunteer understands the purpose, modalities and potential risk of the trial
  4. Volunteers able to read and understand English
  5. Volunteers willing to sign the informed consent

AD patients:

  1. Volunteers with AD defined according to the UK working party diagnostic criteria
  2. Must have an AD lesion present at either the right or left forearm (Proximal end).
  3. For 10 participants in each AD group: visible AD lesion present on either the right or left cheek.
  4. 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 Criteria:

  1. 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.
  2. Three or more bleach baths during any week within 4 weeks.
  3. Treatment with biologics within 5 half-lives (if known) or 12 weeks.
  4. 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.
  5. 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.
  6. Volunteers with acne, suntan, birth marks, multiple nevi, tattoos, blemishes or dense body hair that obstruct the test areas.
  7. Volunteers with a condition that in the opinion of the investigator contradicts participation in the study.
  8. Volunteer is incapable of giving fully informed consent.
  9. Volunteers judged by the PI to be inappropriate for the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04295824


Contacts
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Contact: Aimee Card 01142265945 aimee.card@nhs.net
Contact: Simon Danby, PhD +44(0)1142459563 s.danby@sheffield.ac.uk

Locations
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United Kingdom
Sheffield Dermatology Research, University of Sheffield Medical School, The Royal Hallamshire Hospital
Sheffield, South Yorkshire, United Kingdom, S10 2JF
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
University of Sheffield
Sheffield Children's NHS Foundation Trust
Investigators
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Principal Investigator: Michael J Cork, MD+PhD University of Sheffield & Sheffield Teaching Hospitals
Study Chair: Simon G Danby, PhD University of Sheffield
Additional Information:
Publications:

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Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04295824    
Other Study ID Numbers: STH20628
First Posted: March 5, 2020    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
atopic dermatitis
atopic eczema
optical coherence tomography
skin biopsy
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases