Understanding skin structure in atopic dermatitis

Characterisation of Skin Microstructure Under Normal and Atrophied States

This study looks at the skin of people with atopic dermatitis to see how it changes and to help improve treatment options.

Quick facts

• Study type: Observational
• Enrollment: 180 (estimated)
• Ages: 6 Months and up
• Sex: All
• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust (other)
• Locations: 1 site (Sheffield, South Yorkshire)
• Trial ID: NCT06954272 on ClinicalTrials.gov

What this trial studies

This observational study aims to characterize the skin microstructure in individuals with atopic dermatitis, particularly focusing on both normal and atrophied skin states. Utilizing Optical Coherence Tomography (OCT), the study will generate detailed volumetric scans of the skin to assess inflammation and structural features. The goal is to improve treatment decisions and long-term management of skin conditions by providing new insights into skin characteristics. Participants will include individuals diagnosed with atopic dermatitis who meet specific inclusion criteria.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 6 months and older diagnosed with atopic dermatitis who have controlled symptoms and a history of topical corticosteroid use.

Not a fit: Patients with active eczema or other skin conditions at the measurement sites may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better-informed treatment strategies for patients with atopic dermatitis, potentially improving their quality of life.

How similar studies have performed: While the use of OCT for skin characterization is promising, this specific approach in the context of atopic dermatitis is relatively novel and has not been extensively tested in previous studies.

Eligibility criteria

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 this trial is running

Sheffield, South Yorkshire

• Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS FT — Sheffield, South Yorkshire, United Kingdom (RECRUITING)

Study contacts

• Principal investigator: Michael J Cork, Professor — University of Sheffield
• Study coordinator: Haleema AlFailakawi, MD

Conditions: Atopic Dermatitis