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

Официальное название

Disease Trajectories in Atopic Dermatitis and Psoriasis

Обзор

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

Подробное описание

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.

Вмешательства

• Другое Biosampling for molecular analysis
  Observational study with no therapeutic intervention. Biosampling for molecular analysis

Первичные конечные точки

• Disease progression [Срок оценки: 10 years]
• Molecular signature changes [Срок оценки: 10 years]

Вторичные конечные точки (1)

• Development of comorbidities [Срок оценки: 10 years]

Критерии участия

Критерии включения

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

Критерии исключения

• Patients who decline participation

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Германия · 1 центр

• Department of Dermatology, University Hospital Schleswig Holstein, Campus Kiel — Kiel

Идентификаторы

NCT: NCT03361215 · A100/12a1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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