Atopic DermatitisBIO-ADNCT05099315
Microbiome in Atopic Dermatitis Under Systemic Therapy
An observational study of Atopic Dermatitis, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- not applicable, observational study
- How many people
- 600 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2019to 31 Dec 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with moderate to severe atopic dermatitis presenting in the clinic of Dermatology, Charité - Universitätsmedizin Berlin, Germany.
Who may be able to join
- Patients with moderate to severe atopic dermatitis
- Indication for systemic therapy
Who cannot join
- Patients under 18 years of age upon introducing systemic therapy
- Pregnant and lactating women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Dpt of Dermatology and Allergology, Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, 10117
Sabine Dölle-Bierke, PhD, +49 30 450 518367, sabine.doelle@charite.de
Wojciech Francuzik, Dr. med.
About this study
Official title: Identification of Skin-associated Microbiota in Atopic Dermatitis Patients Undergoing 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.
Read the detailed 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.
- Conditions
- Atopic Dermatitis
- Being tested
- not applicable, observational study
- Keywords
- dupilumab, cyclosporine, skin microbiome, baricitinib
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
not applicable, observational studyOther
Patients undergoing systemic therapy according to international accepted guidelines for the therapy of atopic dermatitis, observational study
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab treated Patients (observational) | Patients with atopic dermatitis with indication for dupilumab treatment will be observed. Receives: Other: not applicable, observational study | |
| Cyclosporine treated Patients (observational) | Patients with atopic dermatitis with indication for cyclosporine treatment will be observed. Receives: Other: not applicable, observational study | |
| Baricitinib treated Patients (observational) | Patients with atopic dermatitis with indication for baricitinib treatment will be observed. Receives: Other: not applicable, observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the microbial composition
Comparison of the microbial composition of the skin before, 6 and 12 months after the initiation of systemic therapy.
Measured: 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).
Measured: 1 year
Secondary outcomes (6)
Microbial composition and skin barrier function
Comparison of the microbial composition of the skin with the skin physiology (including transepidermal water loss, sebumetry)
Measured: 1 year
Correlation of main microbial representants of skin microbiome
Correlation of the S. aureus to the P. acnes ratio
Measured: 1 year
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start1 Oct 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margitta Worm, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099315
- Sponsor's protocol ID
- Microbiome and AD
- Acronym
- BIO-AD
- Status last verified
- Oct 2026
- First submitted
- 20 Jul 2021
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided