跳至主要内容
临床试验/NCT05928169
NCT05928169招募中不适用

Determinants of Chronic Inflammatory Skin Disease Trajectories

University Hospital Schleswig-Holstein2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2023年5月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
2
主要终点
Physician-assessed global disease activity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
0 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • dermatologist-diagnosed inflammatory skin disease
  • informed consent

排除标准

  • subject and/or the legal guardians are not able to give written informed consent
  • pregnant and breastfeeding women
  • concurrent participation in a clinical trial
  • use of systemic immunosuppressive 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 corticosteroids, calcineurin inhibitors or emollients 24 hours before sample collection

结局指标

主要结局

Physician-assessed global disease activity

时间窗: Baseline, week 2, week 4, every 3 months up to 2 years

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

Patient-reported global disease activity

时间窗: Baseline, week 2, week 4, every 3 months up to 2 years

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

Physician-assessed global disease activity

时间窗: Baseline, week 2, week 4, every 3 months up to 2 years

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

Patient-reported global disease activity

时间窗: Baseline, week 2, week 4, every 3 months up to 2 years

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

次要结局

  • Molecular features(Baseline, week 2, week 4, every 3 months up to 2 years)

研究者

发起方
University Hospital Schleswig-Holstein
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Stephan Weidinger

Prof. Dr. Stephan Weidinger

University Hospital Schleswig-Holstein

研究点 (2)

Loading locations...

相似试验