Identification of Skin-associated Microbiota in Atopic Dermatitis Patients Undergoing Systemic Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Comparison of the microbial composition
研究概览
简要总结
The skin microbiome plays a role in the pathogenesis of atopic dermatitis. However, it is unclear whether the range of microbiota on the skin is the cause or consequence of atopic skin inflammation.
The influence of new systemic therapies for the treatment of moderate to severe atopic dermatitis (such as biologics or Janus kinase inhibitors) on the skin microbiome is largely unknown.
The main aim of this scientific exploratory study is to investigate whether and how the skin microbiome changes in patients with moderate to severe atopic dermatitis during systemic therapy. This not only allows new hypotheses to be generated on the pathogenesis of atopic dermatitis, but also new objective scales for the severity of atopic dermatitis can be developed.
详细描述
A better understanding of the pathology of atopic dermatitis could lead to the development of new therapeutic strategies for this disease and contribute to better and more targeted disease management - an advantage for all patients with atopic dermatitis.
The routine examinations are carried out every quarter with routine visits over two years. The dates before, 6, 12, and 24 months after the initiation of systemic therapy are relevant for this study. Deviations from normal practice are not intended.
Patients in whom a new initiation of systemic therapy is planned will be invited for a follow-up 6 weeks after initiation and quarterly follow-up visits.
Blood samples must be obtained for the examination. The blood is taken to determine the systemic level of inflammatory mediators (serological biomarkers, PBMCs) and for genetic examinations (e.g. filaggrin gene mutation - FLG) as well as mRNA / lncRNA profile. The skin physiological examinations are not invasive or pain-related procedures. Microbiome sampling will be conducted by a skin swab of the inter-scapular region.
The blood / skin samples taken as part of this scientific study are pseudonymized in the research laboratories. The samples are stored in the laboratories for a period of 5 years after the end of the study and then destroyed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with moderate to severe atopic dermatitis
- •Indication for systemic therapy
排除标准
- •Patients under 18 years of age upon introducing systemic therapy
- •Pregnant and lactating women
结局指标
主要结局
Comparison of the microbial composition
时间窗: 1 year
Comparison of the microbial composition of the skin before, 6 and 12 months after the initiation of systemic therapy.
Comparison of microbial composition of the skin with serological biomarkers
时间窗: 1 year
Comparison of microbial composition of the skin with serological biomarkers (z.B.TARC, TSLP, CCL27).
次要结局
- Association of the skin microbiome with the mRNA EASI(2 years)
- Correlation of microbiome and severity of atopic dermatitis EASI(2 years)
- Association of the skin microbiome with the mRNA SCORAD(2 years)
- Correlation of main microbial representants of skin microbiome(1 year)
- Microbial composition and skin barrier function(1 year)
- Correlation of microbiome and severity of atopic dermatitis SCORAD(2 years)
研究者
Margitta Worm
Prof. Dr. med. Margitta Worm
Charite University, Berlin, Germany