Phase
Condition
Rash
Allergy
Atopic Dermatitis
Treatment
crisaborole (2%) ointment
betamethasone valerate 0.1% cream
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
Exclusion Criteria:
Participants with a known allergy/hypersensitivity to any of the excipients of thetrial preparations.
Participants with acne, suntan, birth marks, multiple nevi, tattoos, blemishes ordense body hair that obstruct the test areas.
Investigator assessment of eczema severity at the treatment (anatomical) sites isalmost clear or greater (score ≥1) based on the Investigators static globalassessment scale at screening and baseline. At the start of the study the skin ofthe test sites (forearms) will therefore be clear (0) of the signs of eczema
Participants with a condition that in the opinion of the investigator contradictsparticipation in the study.
Pregnant female participants; breastfeeding female participants; and femaleparticipants of childbearing potential who are unwilling or unable to use a highlyeffective method of contraception as outlined in this protocol for the duration ofthe 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. Participants using any topicalproducts on the test areas within 7 days at the screening visit will be eligible ifthey are willing and able to wash-out these products for 7 days in total and for theduration of the trial. Such participants will be potentially eligible at screeningand will be confirmed as eligible if adequate washout is confirmed at visit 1. Useof moisturizers and/or sunscreen is permitted during the study to manage dry skinand sun exposure in areas surrounding but not on or overlapping the test areas.
Participants who have used a tanning bed within 28 days of baseline (visit 1).Participants who have used a sunbed within 28 days at the screening visit will beeligible if they are willing and able to wash-out for 28 days in total and for theduration of the trial. Such participants will be potentially eligible at screeningand will be confirmed as eligible if adequate washout is confirmed at visit 1.
Participants who have used any medication that could interfere with the trial aimprior to the start of the study (baseline/visit 1). Participants using suchmedication at the screening visit will be eligible if they are willing and able towash-out these treatments for the applicable washout period as defined by in section 8.8 'Prior and Concomitant Medication' and for the duration of the trial. Suchparticipants will be potentially eligible at screening and will be confirmed aseligible if adequate washout is confirmed at visit 1.
Participants currently participating in another interventional clinical trial.
Volunteer is incapable of giving fully informed consent.
Participants judged by the PI to be inappropriate for the trial.
Study Design
Study Description
Connect with a study center
Sheffield Dermatology Research, University of Sheffield Medical School, The Royal Hallamshire Hospital
Sheffield, South Yorkshire S10 2JF
United KingdomSite Not Available

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