NCT Number: NCT05099315
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Berlin, State of Berlin, 10117, Germany
Location status: Recruiting
Margitta Worm, Prof. Dr. med.
PRINCIPAL_INVESTIGATOR
Sabine Dölle-Bierke, PhD
CONTACT
Wojciech Francuzik, Dr. med.
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients undergoing systemic therapy according to international accepted guidelines for the therapy of atopic dermatitis, observational study
Time frame: 1 year
Comparison of the microbial composition of the skin before, 6 and 12 months after the initiation of systemic therapy.
Time frame: 1 year
Comparison of microbial composition of the skin with serological biomarkers (z.B.TARC, TSLP, CCL27).
Time frame: 1 year
Comparison of the microbial composition of the skin with the skin physiology (including transepidermal water loss, sebumetry)
Time frame: 1 year
Correlation of the S. aureus to the P. acnes ratio
Time frame: 2 years
Correlation of the microbiome with the Eczema Area and Severity Index (EASI). EASI ranges from 0-72, increasing severity with increasing score.
Time frame: 2 years
Correlation of the microbiome with Scoring of Atopic Dermatitis (SCORAD). SCORAD ranges from 0-103, increasing severity with increasing score.
Time frame: 2 years
Correlation of the main representants of skin microbiota and the Eczema Area and Severity Index (EASI). EASI ranges from 0-72, increasing severity with increasing score.
Time frame: 2 years
Correlation of the main representants of skin microbiota and Scoring of Atopic Dermatitis (SCORAD). SCORAD ranges from 0-103, increasing severity with increasing score.
Contact information is provided by the study sponsor or research team.
Margitta Worm, Prof
CONTACT
Sabine Dölle-Bierke, PhD
CONTACT
Charite University, Berlin, Germany
Other
Identification of Skin-associated Microbiota in Atopic Dermatitis Patients Undergoing Systemic Therapy
Acronym: BIO-AD
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