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NCT Number: NCT05099315

Microbiome in Atopic Dermatitis Under Systemic Therapy

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dpt of Dermatology and Allergology, Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

not applicable, observational study

Other

Patients undergoing systemic therapy according to international accepted guidelines for the therapy of atopic dermatitis, observational study

Primary outcomes

  1. Comparison of the microbial composition

    Time frame: 1 year

    Comparison of the microbial composition of the skin before, 6 and 12 months after the initiation of systemic therapy.

  2. Comparison of microbial composition of the skin with serological biomarkers

    Time frame: 1 year

    Comparison of microbial composition of the skin with serological biomarkers (z.B.TARC, TSLP, CCL27).

Secondary outcomes

  1. Microbial composition and skin barrier function

    Time frame: 1 year

    Comparison of the microbial composition of the skin with the skin physiology (including transepidermal water loss, sebumetry)

  2. Correlation of main microbial representants of skin microbiome

    Time frame: 1 year

    Correlation of the S. aureus to the P. acnes ratio

  3. Correlation of microbiome and severity of atopic dermatitis EASI

    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.

  4. Correlation of microbiome and severity of atopic dermatitis SCORAD

    Time frame: 2 years

    Correlation of the microbiome with Scoring of Atopic Dermatitis (SCORAD). SCORAD ranges from 0-103, increasing severity with increasing score.

  5. Association of the skin microbiome with the mRNA EASI

    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.

  6. Association of the skin microbiome with the mRNA SCORAD

    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.

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Acronym: BIO-AD

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Oct 29, 2021
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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