Atopic DermatitisNCT05928169
Determinants of Chronic Inflammatory Skin Disease Trajectories
An observational study of Atopic Dermatitis and Psoriasis, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial summary
Although it is well known that the clinical expression and course of chronic inflammatory skin diseases are highly variable, there are insufficient epidemiological data on this, and the factors that determine the manifestation, clinical features and course are also largely unknown. Read more about this study
- Who is it for?
- Ages 0 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, Psoriasis, Lichen Planus
- What is being tested?
- Topical and systemic drugs
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2023to 31 Dec 2032
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with chronic inflammatory skin disease Healthy control individuals
Who may be able to join
- dermatologist-diagnosed inflammatory skin disease
- informed consent
Who cannot join
- subject and/or the legal guardians are not able to give written informed consent
- pregnant and breastfeeding women
- concurrent participation in a clinical trial
- use of systemic immunosuppressive therapy or phototherapy during the last 4 weeks or receipt of biologics therapy (e.g. dupilumab, tralokinumab) within the last 3 months
- treatment of the target skin areas with topical corticosteroids, calcineurin inhibitors or emollients 24 hours before sample collection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Dermatology and Allergy, University Hospital Schleswig-Holstein
Kiel, 24105
Stefanie Sievers, 0049431500 ext. 21102, ssievers@dermatology.uni-kiel.de
Jacline Wendler, 0049431500 ext. 21101, jwendler@dermatology.uni-kiel.de
About this study
Although it is well known that the clinical expression and course of chronic inflammatory skin diseases are highly variable, there are insufficient epidemiological data on this, and the factors that determine the manifestation, clinical features and course are also largely unknown. There are currently no reliable markers that could predict or delineate patient subgroups to support patient management. The aim of this project is to identify clinical and molecular factors that correlate with disease, disease subtypes and progression through in-depth long-term clinical characterization of patients with chronic inflammatory skin diseases and examination of individual biomaterials.
Read the detailed description
Chronic inflammatory skin diseases such as atopic dermatitis (AD), psoriasis (Pso), Hidradenitis suppurativa (HS), cutaneous Lupus erythematosus (LE), Lichen planus (Lp) and Vitiligo (V) are very heterogeneous diseases. Onset, clinical features, disease severity, individual trigger factors and response to therapy vary widely between patients and over time, presenting a clinical challenge for diagnosis, counseling, and individualization of management. With the growing interest in inflammatory skin diseases, the need has been recognized to better investigate their natural course and trajectories, associations with environmental and lifestyle factors, and clinical and molecular features underlying their heterogeneity. Initial pilot studies suggested disease subtypes that differ molecularly and/or clinically; however, molecular profiles in particular are subject to variation over time and not necessarily stable. To confirm and extend such preliminary observations, a larger cohort of patients will be studied with careful longitudinal clinical characterization as well as repeatedly obtained specimens, in order to gain deeper insights into disease dynamics. In particular, we will search for clinical and molecular factors that correlate with disease progression and subtypes, and investigate variability in the regulation of molecular mechanisms over time and at resolution and flare-ups.
- Conditions
- Atopic Dermatitis, Psoriasis, Lichen Planus, Alopecia Areata, Hidradenitis Suppurativa, Prurigo Nodularis
- Being tested
- Topical and systemic drugs
- Keywords
- Inflammatory Skin Diseases, Atopic Dermatitis, Psoriasis, Lupus erythematosus, Hidradenitis suppurativa, Vitiligo, Lichen planus, Prurigo nodularis
- Medical subject headings
- Dermatitis, Atopic, Psoriasis, Lichen Planus, Alopecia Areata, Hidradenitis Suppurativa, Rosacea, Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical and systemic drugsDrug
Observational study, treatment decisions are made independently as part of routine clinical care. Recruitment and follow-up will be independent on the type of treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician-assessed global disease activity
Change in Investigator Global Assessment (IGA, 0-5)
Measured: Baseline, week 2, week 4, every 3 months up to 2 years
Patient-reported global disease activity
Change in Patient Global Assessment (IGA, 0-5)
Measured: Baseline, week 2, week 4, every 3 months up to 2 years
Secondary outcomes (1)
Molecular features
Molecular and histopathological profiles in lesional skin and blood compared across diseases, over time and in response to therapy
Measured: Baseline, week 2, week 4, every 3 months up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 May 2023
- Primary completion30 Apr 2032 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Stephan Weidinger, University Hospital Schleswig-Holstein
- Investigators
- Sascha Gerdes, MD, Study director, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928169
- Sponsor's protocol ID
- D452/23
- Status last verified
- Aug 2026
- First submitted
- 1 Jun 2023
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD can be made available only to individual collaborating researchers in compliance with other researchers in line with national as well as international data protection laws (e.g. GDPR, DSGVO)