Skin Pathology Assessment With Optical Technologies

NCT04295824 | Completed

• 1 other identifier: STH20628
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis Eczema

Keywords

atopic dermatitis; atopic eczema; optical coherence tomography; skin biopsy

Outcome Measures

Primary Outcomes (1)

• Local clinical severity

  Primary endpoint: Local clinical severity (erythema, papulation, excoriation and lichenification) of test skin sites

  baseline visit 1

Secondary Outcomes (9)

• Skin epidermal thickness

  baseline visit 1

• Skin vascular plexus depth

  baseline visit 1

• Skin vascular density/diameter

  baseline visit 1

• Skin collagen index

  baseline visit 1

• Skin surface roughness

  baseline visit 1

Study Arms (4)

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

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

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

Healthy

20 healthy volunteers

Diagnostic Test: Skin imaging and Skin biopsy

Interventions

Skin imaging and Skin biopsy DIAGNOSTIC_TEST

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; Mild AD; Moderate AD; Severe AD

Eligibility Criteria

• Age: 11 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patient with atopic dermatitis/atopic eczema and Healthy Controls

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• University of Sheffield: collaborator
• Sheffield Children's NHS Foundation Trust: collaborator

Study Sites (1)

Sheffield Dermatology Research, University of Sheffield Medical School, The Royal Hallamshire Hospital

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

Related Publications (43)

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Related Links

• J. Ring, B. Przybilla, and T. Ruzicka, Handbook of Atopic Eczema, J. Ring, B. Przybilla, and T. Ruzicka, Eds., Springer-Verlag, Berlin/Heidelberg (2006) \[doi:10.1007/3-540-29856-8\]
• J. Ring, "General Introduction and Epidemiology," in Atopic Dermatitis, pp. 1-25, Springer International Publishing, Cham (2016) \[doi:10.1007/978-3-319-22243-1\_1\].
• Lu, Boadi et al., "Optical coherence tomography demonstrates differential epidermal thinning of human forearm volar skin after 2 weeks application of a topical corticosteroid vs a non- steroidal anti-inflammatory alternative," 85650C (2013) \[doi:10.111

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

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Michael J Cork, MD+PhD

  University of Sheffield & Sheffield Teaching Hospitals

  PRINCIPAL INVESTIGATOR

• Simon G Danby, PhD

  University of Sheffield

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: March 5, 2020
• Study Start: August 6, 2020
• Primary Completion: July 29, 2022
• Study Completion: July 29, 2022
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)