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
- Are there results?
- Not yet: the study is under way
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)
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Chronic Inflammatory Skin Disease Trajectories
- ClinicalTrials.gov ID
- NCT05928169
- Acronym / sponsor ID
- D452/23
- Conditions
- Atopic Dermatitis, Psoriasis, Lichen Planus, Alopecia Areata, Hidradenitis Suppurativa, Prurigo Nodularis
- Keywords
- Inflammatory Skin Diseases, Atopic Dermatitis, Psoriasis, Lupus erythematosus, Hidradenitis suppurativa, Vitiligo, Lichen planus, Prurigo nodularis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Apr 2032 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with chronic inflammatory skin disease Healthy control individuals
Key inclusion criteria (2 listed)
- dermatologist-diagnosed inflammatory skin disease
- informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical and systemic drugsObservational study, treatment decisions are made independently as part of routine clinical care. Recruitment and follow-up will be independent on the type of treatment | Drug | – |
Primary outcome
Physician-assessed global disease activity
Time frame: Baseline, week 2, week 4, every 3 months up to 2 years
Change in Investigator Global Assessment (IGA, 0-5)
Patient-reported global disease activity
Time frame: Baseline, week 2, week 4, every 3 months up to 2 years
Change in Patient Global Assessment (IGA, 0-5)
1 secondary outcome
Molecular features
Time frame: Baseline, week 2, week 4, every 3 months up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: 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)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sascha Gerdes, MD study director
University Hospital Schleswig-Holstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis and Psoriasis, run by University Hospital Schleswig-Holstein at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephan Weidinger, MD (0049431500 ext. 21101, sweidinger@dermatology.uni-kiel.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician-assessed global disease activity (time frame: Baseline, week 2, week 4, every 3 months up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.