Active — Not RecruitingNot Applicable

Effects of Abrocitinib Treatment on Skin Barrier Function

Germany20 participantsStarted 2022-09-01

Plain-language summary

Effects of abrocitinib treatment of atopic dermatitis on skin barrier function.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

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

Trial details

NCT IDNCT05140239

SponsorProf. Dr. Stephan Weidinger

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-09-30

View on ClinicalTrials.gov More Atopic Dermatitis trials