Prospective study on effects of abrocitinib treatment of moderate to severe atopic dermatitis on skin barrier functio
- Conditions
- L20.9Atopic dermatitis, unspecified
- Registration Number
- DRKS00028981
- Lead Sponsor
- niversitätsklinikum Schleswig-Holstein, Campus Kiel, Abteilung für Dermatologie, Allergologie und Venerologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
1. Written informed consent obtained from the subject prior to performing any protocol-related procedures, 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
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 assessment 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 corticosteroids 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 therapy (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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in transepidermal water loss (TEWL) at one non-lesional and one lesional marker skin area at week 12 (day 84) compared to baseline/week 0 (day 0).
- Secondary Outcome Measures
Name Time Method To analyse the effect of abrocitinib treatment on the epidermal transcriptome.<br>To investigate the effect of abrocitinib treatment on the skin proteome.<br>To investigate the effect of abrocitinib treatment on the skin microbiome