Clinical trial NCT05140239: Effects of Abrocitinib Treatment on Skin Barrier Function
Official title: Effects of Abrocitinib Treatment of Moderate to Severe Atopic Dermatitis on Skin Barrier Function
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atopic Dermatitis
Keywords: Skin Barrier
Atopic Dermatitis
Dermatology
Skin Physiology
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (n=20) with moderate to severe atopic dermatitis who are eligible for and will receive systemic therapy with abrocitinib by their treating dermatologist as part of standard healthcare. The choice of therapy is strictly done by the treating dermatologist only, and the reasons for the choice will be captured by a structured documentation.

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

Eligibility criteria: Inclusion Criteria:

1. Written informed consent obtained from the subject prior to performing any protocol-related pro-cedures, including screening evaluations
2. Age ≥ 18 years at time of study entry.
3. Diagnosis of chronic atopic dermatitis for at least 1 year prior to enrollment based on American Academy Criteria
4. Eczema Area and Severity Index (EASI) score ≥12 at baseline visit (Week 0)
5. Investigator Global Assessment (IGA) ≥3 at baseline visit (Week 0)
6. Subject is willing and able to comply with the protocol for the duration of the study
7. Subject receives abrocitinib by the treating dermatologist within routine care

Exclusion Criteria:

1. 1. Subject is unable to provide written informed consent or comply with the protocol
2. 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.
3. 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.
4. Known active allergic or irritant contact dermatitis that is likely to interfere with the assessment of severity of AD.
5. 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
6. 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.
7. Treatment of skin areas of examination with emollients 24 hours prior to baseline visit and throughout the study.
8. Involvement in the planning and/or conduct of the study.

Primary outcomes:
measure: 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).
timeFrame: 12 Weeks
Secondary outcomes:
measure: Number of epidermal barrier-related genes/pathways differentially expressed in a marker lesional skin site at week 2 and week 12 compared to baseline
timeFrame: 12 Weeks
measure: Epidermal thickness and epidermal differentiation markers in a marker lesional skin site at week 2 and week 12 compared to baseline
timeFrame: 12 Weeks
measure: Stratum corneum biomarker (cytokine) levels (pg/μg protein) in marker skin sites at week 2 and week 12 compared to baseline
timeFrame: 12 Weeks
measure: Composition of Bacterial Taxa of one lesional and non-lesional marker skin area at week 2 and week 12 compared to baseline
timeFrame: 12 Weeks
Other outcomes:
measure: Transcriptional profile of the keratinocytes in one lesional marker skin area at week 2 and 12 compared to baseline
timeFrame: 12 Weeks
Locations:
city: Kiel
country: Germany
facility: UKSH, Campus Kiel
state: Schleswig-Holstein
Study officials:
affiliation: UKSH Kiel, University of Kiel
name: Stephan Weidinger, MD
role: PRINCIPAL_INVESTIGATOR
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