Validation of a novel composite of skin biomarkers as a primary outcome measure for evaluating the safety of treatments for atopic dermatitis: a randomized controlled trial (phase 2) comparing the effects of crisaborole 2% ointment to betamethasone valerate 0.1% cream on skin structure and function in participants with atopic dermatitis. - Skin bioMARkers for atopic eczema Therapy evaluation

Sheffield Teaching Hospitals NHS Foundation Trust0 sites37 target enrollmentJanuary 6, 2020

Conditionsatopic eczema (synonym atopic dermatitis) and the adverse treatment side effect epidermal atrophy MedDRA version: 21.1Level: LLTClassification code 10003641Term: Atopic eczemaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 21.0Level: PTClassification code 10040799Term: Skin atrophySystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

DrugsEucrisa Betnovate Cream

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: atopic eczema (synonym atopic dermatitis) and the adverse treatment side effect epidermal atrophy
Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Enrollment: 37
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 6, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Eligibility Criteria

Inclusion Criteria

•1\.Adult participants with AD defined according to the UK working party diagnostic criteria
•2\.Male or female aged 18\-65 years old at baseline (Visit 1\)
•3\.Participants 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
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 37
•F.1\.3 Elderly (\>\=65 years) no

Exclusion Criteria

•1\.Participants undergoing active drug treatment for AD (excludes the use of emollients) at baseline (Visit 1\) and subject to any applicable washout period as defined by in section 8\.8 ‘Prior and Concomitant Medication’
•2\.Participants with a known allergy/hypersensitivity to any of the excipients of the trial investigational medicinal products.
•3\.Participants with acne, suntan, birth marks, multiple nevi, tattoos, blemishes or dense body hair that obstruct the test areas.
•4\.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.
•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. 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\).
•9\.Participants who have used any medication that could interfere with the trial aim prior to the start of the study (baseline/visit 1\) treatment, and subject to the applicable washout period, as define in section 8\.8 ‘Prior and Concomitant Medication’.
•10\.Participants currently participating in another interventional clinical trial.