Atopic eczema/dermatitis Skin and Connective Tissue Diseases
Conditions
Interventions
Twice-daily self-administered application of 1 finger-tip unit (FTU) of either crisaborole (2%) ointment or betamethasone valerate (0.025%) cream to the designated treatment areas on the arms (volar f
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Volunteers with AD, defined according to the UK working party diagnostic criteria, not currently undergoing, or requiring, active drug treatment at baseline (visit 1) 2. Male or female aged 18-64 years old at baseline (Visit 1) 3. Volunteer understands the purpose, modalities and potential risk of the trial 4. Participants able to read and understand English 5. Participants willing to sign the informed consent
Exclusion criteria
Exclusion criteria: 1. Participants with a known allergy/hypersensitivity to any of the excipients of the trial preparations. 2. Participants with acne, suntan, birth marks, multiple nevi, tattoos, blemishes or dense body hair that obstruct the test areas. 3. Investigator assessment of eczema severity at the measurement (anatomical) sites on the volar forearm and cheek is almost clear or greater (score =1) based on the Investigators static global assessment (ISGA) scale at screening and baseline. At the start of the study the skin of the volar forearm and cheek measurement sites will therefore be clear (0) of the signs of eczema. 4. Investigator assessment of eczema severity at the measurement (anatomical) sites on the antecubital fossae is moderate or severe (score =3) based on the Investigators static global assessment (ISGA) scale at screening and baseline. At the start of the study the skin of the antecubital fossa measurement sites will therefore be clear (0) of the signs of eczema, almost clear (1) or mild (2). 5. Participants with a condition that in the opinion of the investigator contradicts participation in the study. 6. 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. 7. 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 topical products on the test areas within 7 days at the screening visit will be eligible if they are willing and able to wash-out these products for 7 days in total and for the duration of the trial. Such participants will be potentially eligible at screening and will be confirmed as eligible if adequate washout is confirmed at visit 1. Use of moisturizers and/or sunscreen is permitted during the study to manage dry skin and sun exposure in areas surrounding but not on or overlapping the test areas. 8. 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 be eligible if they are willing and able to wash-out for 28 days in total and for the duration of the trial. Such participants will be potentially eligible at screening and will be confirmed as eligible if adequate washout is confirmed at visit 1. 9. Participants who have used any medication that could interfere with the trial aim prior to the start of the study (baseline/visit 1). Participants using such medication at the screening visit will be eligible if they are willing and able to wash-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. Such participants will be potentially eligible at screening and will be confirmed as eligible if adequate washout is confirmed at visit 1. 10. Participants currently participating in another interventional clinical trial. 11. Volunteer is incapable of giving fully informed consent. 12. Participants judged by the PI to be inappropriate for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in the change in epidermal thickness (day 29 – day 1) on the volar forearm, measured by structural OCT, between the sites treated with crisaborole (2%) ointment and betamethasone valerate (0.025%) cream. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The difference in the change in epidermal thickness (day 29 – day 1) on the antecubital fossa, measured by structural OCT, between the sites treated with crisaborole (2%) ointment and betamethasone valerate (0.025%) cream. 2. The difference in the change in epidermal thickness (day 15 – day 1) on the cheeks, measured by structural OCT, between the sites treated with crisaborole (2%) ointment and betamethasone valerate (0.025%) cream. 3. The difference in the change in epidermal thickness measured by structural OCT and angiographic OCT (superficial plexus depth in µm) during and after 28 days treatment on the volar forearms, antecubital fossae and cheeks on day 1, 15, 29 and day 57 from the volar forearm and antecubital fossa and on day 1, 15, and day 57 4. The difference in the change in visual redness/erythema score and objective redness during and after treatment on day 1, 15, 29 and day 57 from the volar forearm and antecubital fossa and on day 1, 15, and day 57 5. The difference in the change in TEWL during and after treatment on day 1, 15, 29 and day 57 from the volar forearm and antecubital fossa and on day 1, 15, and day 57 6. The difference in the change in skin barrier integrity/STS (day 29 – day 1) on the volar forearms (TEWLts20) and antecubital fossae (TEWLts10). 7. The difference in the change in visual skin dryness on the volar forearms, antecubital fossae and cheeks during and after treatment on day 1, 15, 29 and day 57 from the volar forearm and antecubital fossa and on day 1, 15, and day 57 | — |
Countries
United Kingdom
Outcome results
None listed