Atopic Dermatitis (Eczema)NCT07573735
Assessment of cfDNA-STING Axis as a Potential Pathological Marker in Atopic Dermatitis
An observational study of Atopic Dermatitis (Eczema), run by Zhongda Hospital at 1 site in China.
Trial summary
Study Overview Atopic dermatitis (AD), commonly known as eczema, is a chronic inflammatory skin condition characterized by intense itching and skin barrier damage. While researchers know that the immune system is overactive in AD, it is difficult to measure the exact level of "damage" or "inflammation" happening deep… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis (Eczema)
- What is being tested?
- blood sampling
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 31 Jul 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: This group consists of patients diagnosed with Atopic Dermatitis according to the Hanifin and Rajka criteria or the Williams diagnostic criteria.
Who may be able to join
- Age 18 years or older
- Confirmed diagnosis of Atopic Dermatitis
Who cannot join
- Use of systemic immunosuppressants, systemic corticosteroids, or biological agents within 4 weeks prior to enrollment
- Use of topical treatments within 2 weeks prior to enrollment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital, Southeast University
Nanjing, Jiangsu
meihong Da, 025-83272015, huyk1997@163.com
About this study
Official title: An Observational Study on the Correlation Between Circulating Cell-free DNA and Skin Macrophage STING Pathway Activation in Patients With Atopic Dermatitis
Study Overview Atopic dermatitis (AD), commonly known as eczema, is a chronic inflammatory skin condition characterized by intense itching and skin barrier damage. While researchers know that the immune system is overactive in AD, it is difficult to measure the exact level of "damage" or "inflammation" happening deep within the skin using only a physical exam.
The Purpose of This Study This study investigates a specific "danger signal" called circulating cell-free DNA (cfDNA). When skin cells are damaged or die due to inflammation, they release tiny fragments of DNA into the bloodstream. The investigators believe these fragments might act as a trigger for the immune system, worsening the disease.
Read more
What the Study Involves Researchers will collect blood samples and small skin biopsies from patients with AD and healthy volunteers.
The study aims to: Compare the levels of cfDNA in the blood of AD patients versus healthy individuals. Determine if higher levels of cfDNA correlate with more severe skin symptoms (measured by scores like SCORAD and EASI). Examine how immune cells in the skin (macrophages) respond to these DNA fragments through a specific biological switch called the STING pathway.
Potential Impact By understanding this "damage-signal" loop, this research may lead to new ways for doctors to monitor AD severity through simple blood tests and could identify new targets for future anti-inflammatory treatments.
Read the detailed description
Scientific Rationale AD is primarily driven by Type 2 (Th2) immune responses; however, the role of innate immune sensing of damage-associated molecular patterns (DAMPs) in maintaining chronic inflammation is less defined. Cell-free DNA (cfDNA) has emerged as a potent DAMP in various autoimmune conditions. This study explores the hypothesis that cfDNA released during epidermal injury and inflammatory cell turnover in AD serves as a ligand for the cyclic GMP-AMP synthase (cGAS) - Stimulator of Interferon Genes (STING) pathway within the skin microenvironment.
Study Objectives Quantification of Systemic DAMPs: To quantify plasma cfDNA concentrations in a cohort of AD patients (n=40) compared to age- and sex-matched healthy controls (n=40) using fluorometric assays. Tissue-Level Mechanism: To characterize the local immune landscape via immunofluorescence (IF) staining of skin biopsies. The study focuses on the infiltration density of CD68+ macrophages and the expression/co-localization of STING protein within these cells.
Methodology Clinical Assessment: Patients undergo standardized dermatological evaluation to determine disease severity. Bio-sampling: Peripheral blood is collected for baseline hematology and cfDNA isolation. For a subset of patients, 4mm punch biopsies are taken from active lesional skin. Data Analysis: Cross-sectional analysis will be used to determine the diagnostic value of cfDNA and its ability to stratify disease severity (Moderate vs. Severe AD). Immunohistochemical quantification will be used to verify the activation of the STING pathway in situ.
- Conditions
- Atopic Dermatitis (Eczema)
- Being tested
- blood sampling
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingBiological
One-time peripheral venous blood collection and/or 4mm punch biopsy for biomarker analysis.
| Study group | Role | What they receive |
|---|---|---|
| AD | This group consists of patients diagnosed with Atopic Dermatitis (AD) according to the Hanifin and Rajka criteria or the Williams diagnostic criteria. Receives: Biological: blood sampling | |
| Control | This group consists of healthy volunteers with no personal or family history of atopic dermatitis, asthma, allergic rhinitis, or other systemic inflammatory and autoimmune diseases. Receives: Biological: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
cfDNA
the quantification of circulating cell-free DNA
Measured: enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start1 Feb 2026
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atopic Dermatitis (Eczema)Studies of the same condition, open and under way.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yakun Hu, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07573735
- Sponsor's protocol ID
- 2025ZDSYLL537P01
- Status last verified
- Jun 2026
- First submitted
- 30 Apr 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect the privacy and confidentiality of the study participants in accordance with ethical committee guidelines and data protection regulations.
Publications
Dong L, Hou YR, Xu N, Gao XQ, Sun Z, Yang QK, Wang LN. Cyclic GMP-AMP synthase recognizes the physical features of DNA. Acta Pharmacol Sin. 2025 Feb;46(2):264-270. doi: 10.1038/s41401-024-01369-7. Epub 2024 Aug 7.
PubMed 39112770Decout A, Katz JD, Venkatraman S, Ablasser A. The cGAS-STING pathway as a therapeutic target in inflammatory diseases. Nat Rev Immunol. 2021 Sep;21(9):548-569. doi: 10.1038/s41577-021-00524-z. Epub 2021 Apr 8.
PubMed 33833439Kopfnagel V, Dreyer S, Zeitvogel J, Pieper DH, Buch A, Sodeik B, Rademacher F, Harder J, Werfel T. Free human DNA attenuates the activity of antimicrobial peptides in atopic dermatitis. Allergy. 2021 Oct;76(10):3145-3154. doi: 10.1111/all.14992. Epub 2021 Jul 16.
PubMed 34176149Schuler CF 4th, Tsoi LC, Billi AC, Harms PW, Weidinger S, Gudjonsson JE. Genetic and Immunological Pathogenesis of Atopic Dermatitis. J Invest Dermatol. 2024 May;144(5):954-968. doi: 10.1016/j.jid.2023.10.019. Epub 2023 Dec 11.
PubMed 38085213
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study on the Correlation Between Circulating Cell-free DNA and Skin Macrophage STING Pathway Activation in Patients With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07573735
- Acronym / sponsor ID
- 2025ZDSYLL537P01
- Conditions
- Atopic Dermatitis (Eczema)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Overview Atopic dermatitis (AD), commonly known as eczema, is a chronic inflammatory skin condition characterized by intense itching and skin barrier damage. While researchers know that the immune system is overactive in AD, it is difficult to measure the exact level of "damage" or "inflammation" happening deep within the skin using only a physical exam.
The Purpose of This Study This study investigates a specific "danger signal" called circulating cell-free DNA (cfDNA). When skin cells are damaged or die due to inflammation, they release tiny fragments of DNA into the bloodstream. The investigators believe these fragments might act as a trigger for the immune system, worsening the disease.
What the Study Involves Researchers will collect blood samples and small skin biopsies from patients with AD and healthy volunteers.
The study aims to: Compare the levels of cfDNA in the blood of AD patients versus healthy individuals. Determine if higher levels of cfDNA correlate with more severe skin symptoms (measured by scores like SCORAD and EASI). Examine how immune cells in the skin (macrophages) respond to these DNA fragments through a specific biological switch called the STING pathway.
Potential Impact By understanding this "damage-signal" loop, this research may lead to new ways for doctors to monitor AD severity through simple blood tests and could identify new targets for future anti-inflammatory treatments.
Detailed description
Scientific Rationale AD is primarily driven by Type 2 (Th2) immune responses; however, the role of innate immune sensing of damage-associated molecular patterns (DAMPs) in maintaining chronic inflammation is less defined. Cell-free DNA (cfDNA) has emerged as a potent DAMP in various autoimmune conditions. This study explores the hypothesis that cfDNA released during epidermal injury and inflammatory cell turnover in AD serves as a ligand for the cyclic GMP-AMP synthase (cGAS) - Stimulator of Interferon Genes (STING) pathway within the skin microenvironment.
Study Objectives Quantification of Systemic DAMPs: To quantify plasma cfDNA concentrations in a cohort of AD patients (n=40) compared to age- and sex-matched healthy controls (n=40) using fluorometric assays. Tissue-Level Mechanism: To characterize the local immune landscape via immunofluorescence (IF) staining of skin biopsies. The study focuses on the infiltration density of CD68+ macrophages and the expression/co-localization of STING protein within these cells.
Methodology Clinical Assessment: Patients undergo standardized dermatological evaluation to determine disease severity. Bio-sampling: Peripheral blood is collected for baseline hematology and cfDNA isolation. For a subset of patients, 4mm punch biopsies are taken from active lesional skin. Data Analysis: Cross-sectional analysis will be used to determine the diagnostic value of cfDNA and its ability to stratify disease severity (Moderate vs. Severe AD). Immunohistochemical quantification will be used to verify the activation of the STING pathway in situ.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AD | – | Biological: blood samplingThis group consists of patients diagnosed with Atopic Dermatitis (AD) according to the Hanifin and Rajka criteria or the Williams diagnostic criteria. |
| Control | – | Biological: blood samplingThis group consists of healthy volunteers with no personal or family history of atopic dermatitis, asthma, allergic rhinitis, or other systemic inflammatory and autoimmune diseases. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This group consists of patients diagnosed with Atopic Dermatitis according to the Hanifin and Rajka criteria or the Williams diagnostic criteria.
Key inclusion criteria (2 listed)
- Age 18 years or older
- Confirmed diagnosis of Atopic Dermatitis
Key exclusion criteria (2 listed)
- Use of systemic immunosuppressants, systemic corticosteroids, or biological agents within 4 weeks prior to enrollment
- Use of topical treatments within 2 weeks prior to enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplingOne-time peripheral venous blood collection and/or 4mm punch biopsy for biomarker analysis. | Biological | AD, Control |
Primary outcome
cfDNA
Time frame: enrollment
the quantification of circulating cell-free DNA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Background: PubMed 39112770Dong L, Hou YR, Xu N, Gao XQ, Sun Z, Yang QK, Wang LN. Cyclic GMP-AMP synthase recognizes the physical features of DNA. Acta Pharmacol Sin. 2025 Feb;46(2):264-270. doi: 10.1038/s41401-024-01369-7. Epub 2024 Aug 7.
- Background: PubMed 33833439Decout A, Katz JD, Venkatraman S, Ablasser A. The cGAS-STING pathway as a therapeutic target in inflammatory diseases. Nat Rev Immunol. 2021 Sep;21(9):548-569. doi: 10.1038/s41577-021-00524-z. Epub 2021 Apr 8.
- Background: PubMed 34176149Kopfnagel V, Dreyer S, Zeitvogel J, Pieper DH, Buch A, Sodeik B, Rademacher F, Harder J, Werfel T. Free human DNA attenuates the activity of antimicrobial peptides in atopic dermatitis. Allergy. 2021 Oct;76(10):3145-3154. doi: 10.1111/all.14992. Epub 2021 Jul 16.
- Background: PubMed 38085213Schuler CF 4th, Tsoi LC, Billi AC, Harms PW, Weidinger S, Gudjonsson JE. Genetic and Immunological Pathogenesis of Atopic Dermatitis. J Invest Dermatol. 2024 May;144(5):954-968. doi: 10.1016/j.jid.2023.10.019. Epub 2023 Dec 11.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. To protect the privacy and confidentiality of the study participants in accordance with ethical committee guidelines and data protection regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis (Eczema), run by Zhongda Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cfDNA (time frame: enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07573735, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.