Atopic DermatitisDiTrAPNCT03361215
Disease Trajectories and Anti-cytokine Response Signatures in Atopic Dermatitis and Psoriasis
An observational study of Atopic Dermatitis and Psoriasis, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, Psoriasis, Healthy
- What is being tested?
- Biosampling for molecular analysis
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 16 Mar 2015to 31 Dec 2030
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patient who are beeing treated in the routine care with chronic inflammatory skin diseases will be asked to participate in this project.
Who may be able to join
- Patients with a clinical diagnosis of atopic dermatitis, psoriasis or autoimmune skin disease
- Written informed consent obtained from the subject
Who cannot join
- Patients who decline participation
- In patients<18 years of age no biopsies will be taken
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, University Hospital Schleswig Holstein, Campus Kiel
Kiel, 24105
Stephan Weidinger, MD
Sascha Gerdes, MD
About this study
Official title: Disease Trajectories in Atopic Dermatitis and Psoriasis
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.
- Conditions
- Atopic Dermatitis, Psoriasis, Healthy
- Being tested
- Biosampling for molecular analysis
- Keywords
- Disease progression, Disease course, Immunological characterization
- Medical subject headings
- Dermatitis, Atopic, Psoriasis, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biosampling for molecular analysisOther
Observational study with no therapeutic intervention. Biosampling for molecular analysis
| Study group | Role | What they receive |
|---|---|---|
| Atopic dermatitis | Patients with dermatologist-diagnosed atopic dermatitis, psoriasis or autoimmune skin disease. Receives: Other: Biosampling for molecular analysis | |
| Controls | Healthy volunteers with no history of atopic, autoimmune or chronic inflammatory disease. Receives: Other: Biosampling for molecular analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease progression
Epidemiological and phenotypical data of patients
Measured: 10 years
Molecular signature changes
Molecular signatures will be measured using OMICS and sequencing technologies
Measured: 10 years
Secondary outcomes (1)
Development of comorbidities
Assessment of newly developed comorbid diseases over time
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start16 Mar 2015
- Primary completion15 Mar 2028 (estimated)
- Study completion31 Dec 2030 (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
- Case-control
- 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
- Stephan Weidinger, Prof. Dr., Principal investigator, Dept. of Dermatology University Hospital Kiel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361215
- Sponsor's protocol ID
- A100/12a1
- Acronym
- DiTrAP
- Status last verified
- Jul 2025
- First submitted
- 27 Nov 2017
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disease Trajectories in Atopic Dermatitis and Psoriasis
- ClinicalTrials.gov ID
- NCT03361215
- Acronym / sponsor ID
- DiTrAP / A100/12a1
- Conditions
- Atopic Dermatitis, Psoriasis, Healthy
- Keywords
- Disease progression, Disease course, Immunological characterization
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- 16 Mar 2015 (actual)
- Primary completion
- 15 Mar 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 4 Dec 2017 (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.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atopic dermatitis | – | Other: Biosampling for molecular analysisPatients with dermatologist-diagnosed atopic dermatitis, psoriasis or autoimmune skin disease. |
| Controls | – | Other: Biosampling for molecular analysisHealthy volunteers with no history of atopic, autoimmune or chronic inflammatory disease. |
Who may qualify
- Ages
- 0 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient who are beeing treated in the routine care with chronic inflammatory skin diseases will be asked to participate in this project.
Key inclusion criteria (2 listed)
- Patients with a clinical diagnosis of atopic dermatitis, psoriasis or autoimmune skin disease
- Written informed consent obtained from the subject
Key exclusion criteria (2 listed)
- Patients who decline participation
- In patients<18 years of age no biopsies will be taken
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 |
|---|---|---|
| Biosampling for molecular analysisObservational study with no therapeutic intervention. Biosampling for molecular analysis | Other | Atopic dermatitis, Controls |
Primary outcome
Disease progression
Time frame: 10 years
Epidemiological and phenotypical data of patients
Molecular signature changes
Time frame: 10 years
Molecular signatures will be measured using OMICS and sequencing technologies
1 secondary outcome
Development of comorbidities
Time frame: 10 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 22 Jul 2025.
Related trials for Atopic Dermatitis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
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.
Stephan Weidinger, Prof. Dr. principal investigator
Dept. of Dermatology University Hospital Kiel
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 2 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 22 Jul 2025. 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, Prof. Dr. (+49431500 ext. 21110, 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?
Disease progression (time frame: 10 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 22 Jul 2025.