ClinicalTrials.gg
RecruitingNCT05928169Updated Aug 28, 2026

Determinants of Chronic Inflammatory Skin Disease Trajectories

An observational study in Atopic Dermatitis, Psoriasis and Lichen Planus, sponsored by University Hospital Schleswig-Holstein. Recruiting at 1 site in Germany. Open to participants aged 0 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-28.

Sponsored by University Hospital Schleswig-Holstein · Observational

From the registry’s dates

  • Started May 2023; still recruiting 3 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
0 Years to 80 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Atopic Dermatitis
  • Psoriasis
  • Lichen Planus
  • Alopecia Areata
  • Hidradenitis Suppurativa
  • Prurigo Nodularis
  • Cutaneous Lupus
  • Rosacea

Keywords

  • Inflammatory Skin Diseases
  • Atopic Dermatitis
  • Psoriasis
  • Lupus erythematosus
  • Hidradenitis suppurativa
  • Vitiligo
  • Lichen planus
  • Prurigo nodularis
03

In context

Dermatitis, Atopic

1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 150 across 282 observational studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

University Hospital Schleswig-Holstein is the lead sponsor of 163 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients with chronic inflammatory skin disease Healthy control individuals

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • dermatologist-diagnosed inflammatory skin disease

Exclusion criteria

Exclusion Criteria:

  • subject and/or the legal guardians are not able to give written
  • pregnant and breastfeeding women
  • concurrent participation in a clinical trial
  • use of systemic 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 , calcineurin inhibitors or emollients 24 hours before sample collection
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • DrugTopical and systemic drugs

    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

06

What researchers measure

Primary outcomes

  1. Physician-assessed global disease activity

    Change in Investigator Global Assessment (IGA, 0-5)

    Time frame: Baseline, week 2, week 4, every 3 months up to 2 years

  2. Patient-reported global disease activity

    Change in Patient Global Assessment (IGA, 0-5)

    Time frame: 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

    Time frame: Baseline, week 2, week 4, every 3 months up to 2 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: 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)

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2023 (actual). Primary completion is estimated for Apr 2032, 107 months after the start.

Of 96 non-industry observational studies under Dermatitis, Atopic, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 19. This study's planned 107 months is above that.

Counting every sponsor, half of 170 studies reached it within 35 months; a quarter within 17.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 1, 2023
First posted
Jul 3, 2023
StartActual
May 1, 2023
Primary completionEst.
Apr 30, 2032
CompletionEst.
Dec 31, 2032
Last update
Aug 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05928169
Responsible party
Prof. Dr. Stephan Weidinger (Prof. Dr. Stephan Weidinger, University Hospital Schleswig-Holstein) — Principal investigator
First posted
Jul 3, 2023
Start date
May 1, 2023
Primary completion
Apr 30, 2032 (estimated)
Completion
Dec 31, 2032 (estimated)
Last update
Aug 28, 2026

Study contacts

Stephan Weidinger, MD
Contact
sweidinger@dermatology.uni-kiel.de
0049431500 ext. 21101
Stefanie Sievers
Contact
ssievers@dermatology.uni-kiel.de
0049431500 ext. 21102
Sascha Gerdes, MD
study director · University Hospital Schleswig-Holstein

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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