Skin bioMARkers for Atopic Eczema Therapy Evaluation
United Kingdom37 participantsStarted 2020-11-20
Plain-language summary
The study aims to investigate two new non-invasive technologies for assessing skin properties to identify and validate a range of safety biomarkers that may be considered useful as primary outcome measures for evaluating the safety of topical treatments in atopic dermatitis. The method of assessing these biomarker technologies will be to determine whether twice daily treatment with crisaborole (2%) ointment, compared to betamethasone valerate (0.1%) cream, for up to 4 weeks, may cause skin structure or function changes, like skin atrophy, in patients with atopic dermatitis (AD).
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Volunteers with AD defined according to the UK working party diagnostic criteria
* Male or female aged 18-65 years old at baseline (Visit 1)
* Volunteer understands the purpose, modalities and potential risk of the trial
* Participants able to read and understand English
* Participants willing to sign the informed consent
Exclusion Criteria:
* Participants with a known allergy/hypersensitivity to any of the excipients of the trial preparations.
* Participants with acne, suntan, birth marks, multiple nevi, tattoos, blemishes or dense body hair that obstruct the test areas.
* Investigator assessment of eczema severity at the treatment (anatomical) sites is almost clear or greater (score ≥1) based on the Investigators static global assessment scale at screening and baseline. At the start of the study the skin of the test sites (forearms) will therefore be clear (0) of the signs of eczema
* Participants with a condition that in the opinion of the investigator contradicts participation in the study.
* Pregnant female participants; breastfeeding female participants; and female participants of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
* Use of any topical product on the test areas within 7 days prior to Baseline/Day 1, including cosmetic moisturizers and sunscreen. Parti…
What they're measuring
1
Change in Epidermal Thickness
Timeframe: Day 1 - Day 57
Trial details
NCT IDNCT04194814
SponsorSheffield Teaching Hospitals NHS Foundation Trust