Microbiome in Atopic Dermatitis Under Systemic Therapy

Atopic Dermatitis Clinical Trial

— BIO-AD  

Official title:

Identification of Skin-associated Microbiota in Atopic Dermatitis Patients Undergoing Systemic Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05099315
• Other study ID #: Microbiome and AD
• Status: Recruiting
• Start date: October 1, 2019
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2023
• Source: Charite University, Berlin, Germany
• Contact: Margitta Worm, Prof
• Phone: +49 30 450 518105
• Email: margitta.worm[@]charite.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with moderate to severe atopic dermatitis

• Indication for systemic therapy

Exclusion Criteria:

• Patients under 18 years of age upon introducing systemic therapy

• Pregnant and lactating women

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Other:
• not applicable, observational study
Patients undergoing systemic therapy according to international accepted guidelines for the therapy of atopic dermatitis, observational study

Locations

Country	Name	City	State
Germany	Dpt of Dermatology and Allergology, Charité - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the microbial composition	Comparison of the microbial composition of the skin before, 6 and 12 months after the initiation of systemic therapy.	1 year
Primary	Comparison of microbial composition of the skin with serological biomarkers	Comparison of microbial composition of the skin with serological biomarkers (z.B.TARC, TSLP, CCL27).	1 year
Secondary	Microbial composition and skin barrier function	Comparison of the microbial composition of the skin with the skin physiology (including transepidermal water loss, sebumetry)	1 year
Secondary	Correlation of main microbial representants of skin microbiome	Correlation of the S. aureus to the P. acnes ratio	1 year
Secondary	Correlation of microbiome and severity of atopic dermatitis EASI	Correlation of the microbiome with the Eczema Area and Severity Index (EASI). EASI ranges from 0-72, increasing severity with increasing score.	2 years
Secondary	Correlation of microbiome and severity of atopic dermatitis SCORAD	Correlation of the microbiome with Scoring of Atopic Dermatitis (SCORAD). SCORAD ranges from 0-103, increasing severity with increasing score.	2 years
Secondary	Association of the skin microbiome with the mRNA EASI	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.	2 years
Secondary	Association of the skin microbiome with the mRNA SCORAD	Correlation of the main representants of skin microbiota and Scoring of Atopic Dermatitis (SCORAD). SCORAD ranges from 0-103, increasing severity with increasing score.	2 years