Status:
RECRUITING
Characterisation of Skin Microstructure Under Normal and Atrophied States
Lead Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborating Sponsors:
University of Sheffield
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
6+ years
Brief Summary
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 phy...
Detailed Description
Around 24% of the United Kingdom (UK) population seeks medical attention regarding a skin condition each year, of which 6.1% are referred to specialist dermatology care. Skin conditions are the most c...
Eligibility Criteria
Inclusion
- Male or female aged ≥ 6 months old.
- Volunteers understand the purpose, modalities, and potential risks of the study.
- Volunteers are able to read and understand English.
- Volunteers are willing to sign the informed consent.
- \[Patient cohort only\] Patients diagnosed with AD and
- A recent history of persistent signs (last flare ≥3 months)
- Currently controlled signs (ISGA 0-1; clear-almost clear)
- At least 3 months of TCS use (continuous or intermittent, over the last 6 months)
Exclusion
- Participants with any of the following on the measurement skin site (acne, suntan, birthmarks, multiple nevi, tattoos, blemishes, or dense body hair that obstruct the test areas).
- Visible signs of eczema/inflammation at the general measurement sites. Excluding sites of specific interest (SSI) which are imaged in addition to the general measurement sites.
- Participants with a condition that in the opinion of the investigator contradicts participation in the study.
- \[Healthy cohort only\] Participants with a history of chronic skin conditions (except acne).
- Participants who have used any medication that could interfere with the trial aim prior to the start of the study (baseline/visit 1).
- \[Healthy cohort only\] Use of TCS at any point during the 6 months before the clinical visit (except hydrocortisone use for ≤4 weeks outside the target areas of skin).
- Use of any topical product on the measurement areas within 24 hours prior to the measurement visit (\>6 hours for patients with severe symptoms).
- Volunteers currently participating in an interventional clinical trial.
- Volunteers incapable of giving fully informed consent.
- Volunteers judged by the PI to be inappropriate for the study.
Key Trial Info
Start Date :
July 16 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06954272
Start Date
July 16 2024
End Date
December 1 2025
Last Update
May 1 2025
Active Locations (1)
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1
Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS FT
Sheffield, South Yorkshire, United Kingdom, S10 2JF