Effects of Abrocitinib Treatment on Skin Barrier Function (NCT05140239) | Clinical Trial Compass
CompletedNot 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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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).
. 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.