Characterisation of Skin Microstructure Under Normal and Atrophied States
Recruiting · NCT06954272 · Observational (researchers observe without assigning treatment) · Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
View the official record on ClinicalTrials.gov →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.
Who can take part
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed.
- Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS FT - Sheffield, South Yorkshire, United Kingdom