Microbiome in Atopic Dermatitis Under Systemic Therapy

NCT05099315 | Recruiting

• 1 other identifier: Microbiome and AD
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atopic Dermatitis

Keywords

dupilumab; cyclosporine; skin microbiome; baricitinib

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Microbial composition and skin barrier function

  1 year

• Correlation of main microbial representants of skin microbiome

  1 year

• Correlation of microbiome and severity of atopic dermatitis EASI

  2 years

• Correlation of microbiome and severity of atopic dermatitis SCORAD

  2 years

• Association of the skin microbiome with the mRNA EASI

  2 years

Study Arms (3)

Dupilumab treated Patients (observational)

Patients with atopic dermatitis with indication for dupilumab treatment will be observed.

Other: not applicable, observational study

Cyclosporine treated Patients (observational)

Patients with atopic dermatitis with indication for cyclosporine treatment will be observed.

Other: not applicable, observational study

Baricitinib treated Patients (observational)

Patients with atopic dermatitis with indication for baricitinib treatment will be observed.

Other: not applicable, observational study

Interventions

not applicable, observational study OTHER

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

Baricitinib treated Patients (observational); Cyclosporine treated Patients (observational); Dupilumab treated Patients (observational)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with moderate to severe atopic dermatitis presenting in the clinic of Dermatology, Charité - Universitätsmedizin Berlin, Germany.

You may qualify if:

• Patients with moderate to severe atopic dermatitis
• Indication for systemic therapy

You may not qualify if:

• Patients under 18 years of age upon introducing systemic therapy
• Pregnant and lactating women

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Dpt of Dermatology and Allergology, Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

1. Serum, 2. Peripheral blood mononuclear cells 3. Skin swab for microbiome analysis 4. Genetic examination of the filaggringen mutation status

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Observation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Margitta Worm, Prof

CONTACT

+49 30 450 518105; margitta.worm@charite.de

Sabine Dölle-Bierke, PhD

CONTACT

+49 30 450 518367; sabine.doelle@charite.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Margitta Worm

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: October 29, 2021
• Study Start: October 1, 2019
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

DE (1)