Understanding skin structure in atopic dermatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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
• Email: hhalfailakawi1@sheffield.ac.uk
• Phone: 01142159539

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Roflumilast Cream 0.3% for moderate to severe atopic dermatitis in children, adolescents, and adults

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• ADBest TREAT Registry for adults with atopic dermatitis

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  Recruiting Universitätsklinikum Hamburg-Eppendorf · Hamburg · NCT07904546

• How lebrikizumab affects the skin microbiome and mycobiome in adults with atopic dermatitis

  This study looks at whether lebrikizumab changes the skin bacteria, fungi, and specifically Staphylococcus species, in adults with moderate-to-severe atopic dermatitis.

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• QX-4533 safety study in healthy volunteers and people with moderate-to-severe atopic dermatitis

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  Recruiting Phase 1 QuantX Biosciences US Inc. · Shanghai, Shanghai Municipality · NCT07800104

• Tilrekimig for moderate-to-severe eczema in teens and adults

  A 52-week study will test tilrekimig against dupilumab and a placebo to see if it helps people 12 and older with moderate-to-severe atopic dermatitis.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.