Atopic Dermatitis Clinical Trials

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Characterisation of Skin Microstructure Under Normal and Atrophied States

Status: Recruiting
Location: See location...
Study Type: Observational
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
View:

• 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)

Locations
Other Locations
United Kingdom
Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS FT
RECRUITING
Sheffield
Contact Information
Primary
Haleema AlFailakawi, MD
hhalfailakawi1@sheffield.ac.uk
01142159539
Backup
Kirsty Brown, BSc
kirsty.kennedy@sheffield.ac.uk
01142159539
Time Frame
Start Date: 2024-07-16
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 180
Treatments
Healthy
Participants with healthy skin and no history of skin diseases with the exception of acne.
Atopic dermatitis
Participants with atopic dermatitis and signs of adverse skin changes caused by topical corticosteroid use.
Related Therapeutic Areas
Sponsors
Collaborators: University of Sheffield
Leads: Sheffield Teaching Hospitals NHS Foundation Trust

This content was sourced from clinicaltrials.gov

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