NCT05140239CompletedNot Applicable
Effects of Abrocitinib Treatment of Moderate to Severe Atopic Dermatitis on Skin Barrier Function
Prof. Dr. Stephan Weidinger2 sites in 1 country20 target enrollmentStarted: September 1, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Change in transepidermal water loss (TEWL) at one non-lesional and one lesional marker skin area at week 2 and week 12 compared to baseline/week 0 (day 0).
Study Overview
Brief Summary
Effects of abrocitinib treatment of atopic dermatitis on skin barrier function.
Detailed Description
Open-label, non-randomized, single-arm, 12-weeks observational clinical and translational study
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Written informed consent obtained from the subject prior to performing any protocol-related pro-cedures, including screening evaluations
- •Age ≥ 18 years at time of study entry.
- •Diagnosis of chronic atopic dermatitis for at least 1 year prior to enrollment based on American Academy Criteria
- •Eczema Area and Severity Index (EASI) score ≥12 at baseline visit (Week 0)
- •Investigator Global Assessment (IGA) ≥3 at baseline visit (Week 0)
- •Subject is willing and able to comply with the protocol for the duration of the study
- •Subject receives abrocitinib by the treating dermatologist within routine care
Exclusion Criteria
- •1. Subject is unable to provide written informed consent or comply with the protocol
- •Concurrent enrolment in another clinical trial where the subject is receiving an IMP or participation in another clinical trial with investigational product during the last 30 days before inclusion or 7 half-lives of previously used trial medication, whichever is longer.
- •Active dermatologic conditions that may confound the diagnosis of AD or would interfere with as-sessment of treatment, such as scabies, cutaneous lymphoma, or psoriasis.
- •Known active allergic or irritant contact dermatitis that is likely to interfere with the assessment of severity of AD.
- •Having used systemic immunosuppressive/immunomodulating therapy (e.g. systemic corticoster-oids methotrexate, cyclosporine, azathioprine, mycophenolate mofetil, JAK inhibitors) or tanning beds or phototherapy during any week within the 4 weeks or receipt of any marketed biologic ther-apy (e.g., dupilumab, tralokinumab) within 3 months or 5 half-lives, whichever is longer, prior to baseline
- •Treatment of selected marker skin areas (non-lesional skin at volar forearm and extensor forearm, lesional skin) with topical corticosteroid or topical calcineurin inhibitor 1 week prior to baseline visit and throughout the study.
- •Treatment of skin areas of examination with emollients 24 hours prior to baseline visit and throughout the study.
- •Involvement in the planning and/or conduct of the study.
Outcomes
Primary Outcomes
Change in transepidermal water loss (TEWL) at one non-lesional and one lesional marker skin area at week 2 and week 12 compared to baseline/week 0 (day 0).
Time Frame: 12 Weeks
To determine the mean change of TEWL in g/m2/h at one non-lesional and one lesional marker skin site at week 2 and week 12 compared to baseline
Secondary Outcomes
- Number of epidermal barrier-related genes/pathways differentially expressed in a marker lesional skin site at week 2 and week 12 compared to baseline(12 Weeks)
- Epidermal thickness and epidermal differentiation markers in a marker lesional skin site at week 2 and week 12 compared to baseline(12 Weeks)
- Stratum corneum biomarker (cytokine) levels (pg/μg protein) in marker skin sites at week 2 and week 12 compared to baseline(12 Weeks)
- Composition of Bacterial Taxa of one lesional and non-lesional marker skin area at week 2 and week 12 compared to baseline(12 Weeks)
Investigators
Prof. Dr. Stephan Weidinger
Vice Head, Department of Dermatology and Allergy
University Hospital Schleswig-Holstein
Study Sites (2)
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