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NCT Number: NCT07573735

Assessment of cfDNA-STING Axis as a Potential Pathological Marker in 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.

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.

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Key information

Conditions

Atopic Dermatitis (Eczema) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema 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

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, China

Location status: Recruiting

Location contact

meihong Da

CONTACT

[email protected]

025-83272015

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Age 18 years or older
Confirmed diagnosis of Atopic Dermatitis

Exclusion criteria

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

Treatment and study plan

Blood sampling

Biological

One-time peripheral venous blood collection and/or 4mm punch biopsy for biomarker analysis.

Primary outcomes

cfDNA

Time frame: enrollment

the quantification of circulating cell-free DNA

Sponsors and collaborators

Lead sponsor

Zhongda Hospital

Other

Registry information

Official study title

An Observational Study on the Correlation Between Circulating Cell-free DNA and Skin Macrophage STING Pathway Activation in Patients With Atopic Dermatitis

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: May 7, 2026
Registry last updated: Jun 11, 2026

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

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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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