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NCT Number: NCT03361215

Disease Trajectories and Anti-cytokine Response Signatures 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

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Disease Attributes Disease Progression Genetic Diseases, Inborn Healthy Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Psoriasis Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

0 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Dermatology, University Hospital Schleswig Holstein, Campus Kiel

Kiel, 24105, Germany

Location status: Recruiting

Location contact

Sascha Gerdes, MD

CONTACT

Stephan Weidinger, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients who decline participation

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

Treatment and study plan

Biosampling for molecular analysis

Other

Observational study with no therapeutic intervention. Biosampling for molecular analysis

Primary outcomes

  1. Disease progression

    Time frame: 10 years

    Epidemiological and phenotypical data of patients

  2. Molecular signature changes

    Time frame: 10 years

    Molecular signatures will be measured using OMICS and sequencing technologies

Secondary outcomes

  1. Development of comorbidities

    Time frame: 10 years

    Assessment of newly developed comorbid diseases over time

Study contacts

Contact information is provided by the study sponsor or research team.

Sascha Gerdes, PD Dr.

CONTACT

[email protected]

+49431500 ext. 21151

Stephan Weidinger, Prof. Dr.

CONTACT

[email protected]

+49431500 ext. 21110

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Registry information

Official study title

Disease Trajectories in Atopic Dermatitis and Psoriasis

Acronym: DiTrAP

Important dates

Study start
2015
Primary completion
2028
Study completion
2030
First posted
Dec 4, 2017
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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