Validation of a novel composite of skin biomarkers as a primary outcome measure for evaluating the safety of treatments for atopic dermatitis study 2: a randomised controlled trial (phase 2) comparing the effects of crisaborole 2% ointment to betamethasone valerate 0.025% cream on skin structure and function in participants with atopic dermatitis.

Sheffield Teaching Hospitals NHS Foundation Trust0 sites40 target enrollmentNovember 28, 2022

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Not specified
Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Enrollment: 40
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 28, 2022

End Date

December 31, 2024

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Eligibility 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

•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.