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.
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.
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.
Participants who have used any medication that could interfere with the trial aim prior to the start of the study (baseline/visit 1).
A cohort of 150 healthy skin participants will be identified through advertising to the public (local magazines, email lists, and social media). Healthy skin participants will be subdivided into five age groups (≤30 per group): 1. Children aged 6 months-10 years old. 2. Adolescents aged 11-24 years. 3. Adults aged 25-39 years. 4. Middle age 40-64 years old. 5. Adults of older age 65+. A separate patient cohort of ≤30 participants will also be recruited via clinic appointments at the Royal Hallamshire Hospital and Sheffield Children's Hospital.
Case-control
Cross-sectional
Not listed
To quantify epidermal thickness in people with healthy skin
To quantify epidermal thickness (µm) at various body locations in people with healthy skin
To determine tissue attenuation coefficient of whole skin
To determine tissue attenuation coefficient (mm-1)of whole skin, including the epidermis and dermis, at various body locations in people with healthy skin
To determine the vascular plexus depth in people with healthy skin
To determine the vascular plexus depth (µm) at various body locations in people with healthy skin
To determine the vascular density/diameter in people with healthy skin
To determine the vascular density/diameter (segments mm2/µm) at various body locations in people with healthy skin
To determine the effect of sex on epidermal thickness in people with healthy skin
To determine the effect of sex on epidermal thickness (µm) at various body locations in people with healthy skin
To determine the effect of sex on tissue attenuation coefficient in people with healthy skin
To determine the effect of sex on tissue attenuation coefficient (mm-1) at various body locations in people with healthy skin
To determine the effect of sex on vascular plexus depth in people with healthy skin
To determine the effect of sex on vascular plexus depth (µm) at various body locations in people with healthy skin
To determine the effect of sex on vascular density/diameter in people with healthy skin
To determine the effect of sex on vascular density/diameter (segments mm2/µm) at various body locations in people with healthy skin
To discuss the feasibility of conducting a larger study to ascertain the real-world impact of long-term TCS use.
To discuss the feasibility of conducting a larger study to ascertain the real-world impact of long-term TCS use. This is not a quantitative outcome, rather a discussion of practicalities.
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Sheffield Teaching Hospitals NHS Foundation Trust
Lead sponsor
University of Sheffield
Collaborator
