ClinicalTrials.gg
RecruitingNCT03361215DiTrAPUpdated Jul 22, 2025

Disease Trajectories and Anti-cytokine Response Signatures in Atopic Dermatitis and Psoriasis

An observational study in Atopic Dermatitis, Psoriasis and Healthy, sponsored by University Hospital Schleswig-Holstein. Recruiting at 1 site in Germany. Open to participants aged 0 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-22.

Sponsored by University Hospital Schleswig-Holstein · Observational

From the registry’s dates

  • Started Mar 2015; still recruiting 11 years 7 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
1,000
Ages
0 Years to 100 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 229 studies in Dermatitis, Atopic with a site in Germany — 18 open to participants now, 41 under way, 9 of them phase 3. Dermatitis, Atopic · Germany.

Planned enrollment
7th of 20
1,000 · median 617
Started
2015
with 10 others
Observational
20 of 229
8 open now
Primary completion
2028-03
later than 29 of 40 live
Registered
93rd of 229
by date

Among the 229 studies in Dermatitis, Atopic with a site in Germany, this one is the 7th largest by planned enrollment of the 20 observational ones that give a count, is one of 11 that started in 2015, is one of 20 observational ones, reaches primary completion later than 29 of the 40 other live ones, and was the 93rd registered.

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 →

Open to participants now

18 of the 229 studies in Dermatitis, Atopic with a site in Germany are open now.

All 18 open studies →

A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →

Who these studies take

Of the 193 Dermatitis, Atopic studies recruiting now, 83 (43%) set no upper age limit and 94 (49%) stop at 75 or younger; 93 take children under 18; 51 take healthy volunteers.

This study: 0 Years to 100 Years · all sexes · healthy volunteers too.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 229 studies in Dermatitis, Atopic with a site in Germany, or all of them as a file.
02

Study summary

The clinical study investigates the long-term course of disease in patients with chronic inflammatory skin diseases (atopic eczema and psoriasis) and the impact of tarheted therapies on the clinical and molecular level. For this purpose, patients are asked to take part in regular examinations and data collections, and to donate biomaterials (blood, skin biopsies, skin swabs, tape strips, stool samples). Blood samples are used to analyze inflammation messengers. Punch biopsies from lesional and non-lesional skin areas are used to analyze gene expression. Tape strips are pieces of transparent adhesive tapes to strip off most of the horny layer that will be used to examine mRNA and protein expression. The skin smears are superficial smears of three areas of skin with cotton swabs, which are used to examine bacteria on the skin. Overall, the study will help to monitor the disease course clinically and on the molecular level in participating patients for at least ten years and to collect information about the impact of various external factors including treatments. The study has no effect on the therapies of the disease, it serves only the accompanying data collection

Read the detailed description

Atopic dermatitis and psoriasis are the most common chronic inflammatory skin diseases in dermatology. Due to genetic predispositions, inflammatory changes of the skin occur. The specific mechanisms are only partly understood for both diseases and targeted therapies are established in psoriasis therapy and are becoming available for atopic dermatitis. In order to better understand the course of the disease and to characterize the changes in the inflammatory mechanisms during the course of the disease and under the influence of external factors such as therapies, longitudinal prospective studies are needed to evaluate clinical data and biological samples. This study investigates long-term clinical and epidemiological data from affected patients, as well as biological samples, including blood samples, skin biopsies, non-invasive skin swabs for microbiome detection, and tape strips for the molecular characterization of the disease. Data collection and biosampling will be done during routine visits, typically at week 0, 2, 4, 12 and 52.

03

Conditions studied

  • Atopic Dermatitis
  • Psoriasis
  • Healthy

Keywords

  • Disease progression
  • Disease course
  • Immunological characterization
04

Who can participate

Ages eligible
0 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patient who are beeing treated in the routine care with chronic inflammatory skin diseases will be asked to participate in this project.

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

  • Patients with a clinical diagnosis of atopic dermatitis, psoriasis or skin disease
  • Written obtained from the subject

Exclusion criteria

Exclusion Criteria:

  • Patients who decline participation

In patients\<18 years of age no will be taken

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.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

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.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

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

Groups and cohorts

  • Atopic dermatitis

    Patients with dermatologist-diagnosed atopic dermatitis, psoriasis or autoimmune skin disease.

    Other: Biosampling for molecular analysis

  • Controls

    Healthy volunteers with no history of atopic, autoimmune or chronic inflammatory disease.

    Other: Biosampling for molecular analysis

Interventions

  • OtherBiosampling for molecular analysis

    Observational study with no therapeutic intervention. Biosampling for molecular analysis

06

What researchers measure

Primary outcomes

  1. Disease progression

    Epidemiological and phenotypical data of patients

    Time frame: 10 years

  2. Molecular signature changes

    Molecular signatures will be measured using OMICS and sequencing technologies

    Time frame: 10 years

Secondary outcomes

  1. Development of comorbidities

    Assessment of newly developed comorbid diseases over time

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
  • Department of Dermatology, University Hospital Schleswig Holstein, Campus Kiel
    Kiel, 24105, Germany
    Recruiting
    • Stephan Weidinger, MD · Contact
    • Sascha Gerdes, MD · Contact
08

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 Mar 2015 (actual). Primary completion is estimated for Mar 2028, 155 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 155 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
Nov 27, 2017
First posted
Dec 4, 2017
StartActual
Mar 16, 2015
Primary completionEst.
Mar 15, 2028
CompletionEst.
Dec 31, 2030
Last update
Jul 22, 2025
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 Jul 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03361215
Responsible party
Prof. Dr. Stephan Weidinger (Prof. Dr. med., University Hospital Schleswig-Holstein) — Principal investigator
First posted
Dec 4, 2017
Start date
Mar 16, 2015
Primary completion
Mar 15, 2028 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Jul 22, 2025

Study contacts

Stephan Weidinger, Prof. Dr.
Contact
sweidinger@dermatology.uni-kiel.de
+49431500 ext. 21110
Sascha Gerdes, PD Dr.
Contact
sgerdes@dermatology.uni-kiel.de
+49431500 ext. 21151
Stephan Weidinger, Prof. Dr.
principal investigator · Dept. of Dermatology University Hospital Kiel

Oversight

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

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