Actively Recruiting

Age: 6Months +
All Genders
NCT06954272

Characterisation of Skin Microstructure Under Normal and Atrophied States

Led by Sheffield Teaching Hospitals NHS Foundation Trust · Updated on 2025-05-01

180

Participants Needed

1

Research Sites

71 weeks

Total Duration

On this page

Sponsors

S

Sheffield Teaching Hospitals NHS Foundation Trust

Lead Sponsor

U

University of Sheffield

Collaborating Sponsor

AI-Summary

What this Trial Is About

Skin dermatoses are a major health concern around the world, with heavy economic, social, and psychological burdens. Due to their chronic and incurable nature, they are serious diseases that cause physical pain in patients and reduced quality of life. Atopic dermatitis is the most common inflammatory skin disease with a prevalence of almost 20% in children and 10% in adults. Current therapies are designed to control the condition rather than cure it. Therefore, these therapies are lifelong and, when the disease is flaring, must be used intensively to achieve control. Despite the emergence of various therapies, topical corticosteroids (TCS) remains the gold standard therapy generally used as a first-line treatment. However, if used inappropriately, it can act like a double-edged sword. With the beneficial action of TCS comes the potential for undesirable effects, like skin thinning, especially when used long-term or excessively. The objective of this study is to define the normal structural parameters for healthy skin in a diverse cohort, determine the effect of age, sex, and ethnicity and subsequently study how these values differ in clinically abnormal skin resulting from excessive or inappropriate use of topical corticosteroids (TCS). This will be achieved by using optical coherence tomography (OCT) to non-invasively image the skin. By undertaking this study, the investigators will gain real-world insight into the effects of long-term TCS use on the skin.

CONDITIONS

Official Title

Characterisation of Skin Microstructure Under Normal and Atrophied States

Who Can Participate

Age: 6Months +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 265 6 months old
  • Volunteers who understand the study purpose, procedures, and potential risks
  • Volunteers able to read and understand English
  • Volunteers willing to sign informed consent
  • Patients diagnosed with atopic dermatitis with recent persistent signs (flare within last 3 months)
  • Patients with currently controlled signs (ISGA 0-1; clear or almost clear)
  • Patients with at least 3 months of topical corticosteroid use (continuous or intermittent) in the last 6 months
Not Eligible

You will not qualify if you...

  • Skin issues on measurement sites such as acne, suntan, birthmarks, multiple nevi, tattoos, blemishes, or dense body hair obstructing test areas
  • Visible eczema or inflammation on general measurement sites (except specific sites of interest)
  • Any condition that investigators believe contradicts study participation
  • History of chronic skin conditions (except acne) for healthy cohort
  • Use of medications interfering with the study prior to baseline visit
  • Use of topical corticosteroids within 6 months before visit (except hydrocortisone for less than 4 weeks outside target skin areas) for healthy cohort
  • Use of any topical product on measurement areas within 24 hours prior to measurement visit (more than 6 hours for severe symptoms patients)
  • Current participation in an interventional clinical trial
  • Inability to give fully informed consent
  • Investigator judgment of unsuitability for the study

AI-Screening

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Trial Site Locations

Total: 1 location

1

Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS FT

Sheffield, South Yorkshire, United Kingdom, S10 2JF

Actively Recruiting

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Research Team

H

Haleema AlFailakawi, MD

CONTACT

K

Kirsty Brown, BSc

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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