Systemic sclerosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria for the systemic sclerosis patient group: 1. Meet the 2013 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for systemic sclerosis (SSc); 2. Disease severity is mild to moderate (with an appropriate modified Rodnan skin score (mRSS) range and no severe internal organ involvement); 3. No use of glucocorticoids, disease-modifying antirheumatic drugs (DMARDs), biologics, or other immunosuppressive therapies within three months; 4. Subjects fully understand the study rationale and objectives, voluntarily participate in this study, and sign a written informed consent form. Inclusion criteria for the non-systemic sclerosis patient group: 1. Aged 18 to 70 years; 2. No history of autoimmune diseases; 3. No severe skin diseases; 4. Voluntarily participate in the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Exclusion criteria for the systemic sclerosis patient group: 1. Concurrent other autoimmune or rheumatic diseases (such as systemic lupus erythematosus, rheumatoid arthritis, dermatomyositis, etc.) or conditions that cannot be clearly distinguished from SSc; 2. Presence of active infection, pulmonary arterial hypertension, severe cardiac, hepatic, or renal insufficiency (based on laboratory tests and clinical evaluation), or a history of malignancy; 3. Women who are pregnant or lactating, or women of childbearing age who have not adopted effective contraceptive measures; 4. Any other condition that may interfere with study assessments, affect subject safety or compliance (such as psychiatric disorders, history of substance abuse), or at the investigator's discretion, deems the subject unsuitable for participation in this study. Exclusion criteria for the non-systemic sclerosis patient group: 1. Presence of conditions that cannot be clearly distinguished from systemic sclerosis; 2. Presence of active infection, pulmonary arterial hypertension, severe cardiac, hepatic, or renal insufficiency (based on laboratory tests and clinical evaluation), or a history of malignancy; 3. Any other condition that may interfere with study assessments, affect subject safety or compliance (such as psychiatric disorders, history of substance abuse), or at the investigator’s discretion, deems the subject unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The metabolic characteristics of SSc skin tissue; | — |
Secondary
| Measure | Time frame |
|---|---|
| The extent of fibrosis in skin tissue.;Basic information such as the subject’s gender, age, medical history, medication history, etc.;The expression levels of TGF-ß1, p-Smad2/3, Smad7, a-SMA, and Col I in skin tissue; | — |
Countries
China
Contacts
The First Affiliated Hospital of the Baotou Medical College of Inner Mongolia University of Science and Technology