Atopic dermatitis
Conditions
Interventions
Case group:None
Healthy control group:None
Sponsors
Department of Dermatology, The Second Affiliated Hospital, Health Science Center, Xi’an Jiaotong University
Eligibility
Sex/Gender
All
Age
12 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Be able to read, understand and give informed consent in writing (electronic or paper signature); 2) Atopic dermatitis diagnosed at least 12 months before screening; 3) Moderate to severe AD, including eczema area and Severity Index (EASI) score = 16 at screening; Certified Investigator Global Assessment of Atopic Dermatitis (vIGA-ADTM) =3; =10% body surface area (BSA) involved.
Exclusion criteria
Exclusion criteria: 1) Patients who do not wish to participate in the study; 2) Pregnant or lactating women; 3) Systemic glucocorticoid therapy, systemic immunosuppressive therapy/immunomodulatory therapy (e.g., cyclosporine, mycophenolate, IFN-?, phototherapy (NBUVB, UVB, UVA1, PUVA), azathioprine, methotrexate) within 4 weeks prior to screening; 4) Systemic acute or chronic infection requiring antibiotic, antiviral, antiparasitic, antiparasitic, or antifungal treatment within 4 weeks prior to screening, or herpes simplex infection within 2 weeks prior to screening, or superficial skin infection within 1 week prior to screening. (Note: After the infection resolves, the patient can be re-screened, only once); 5) Have a history of active tuberculosis, or active or latent tuberculosis infection at the time of screening, or suspected tuberculosis infection at the time of screening; 6) Have a history of clinically significant diseases, such as circulatory system abnormalities, endocrine system abnormalities, nervous system diseases or blood system diseases, immune system diseases, mental diseases; 7) When screening or baseline examination, laboratory examination indicators meet any of the following criteria: a) Liver function :AST or ALT or total bilirubin >2 times the upper limit of normal (2×ULN); b) Renal function: serum creatinine >ULN; C) blood routine: hemoglobin (male) < 10.0 g/dL (100.0 g/L), or (female) < 9.0 g/dL (90.0 g/L); Total WBC <3.0×109 /L; Neutrophil count <1.5×109 /L; d. Platelet count <90×109 /L. 8) Situations in which the investigator believes there is a risk to the safety of the subject, or an aggravation of the subject's disease/condition during the study period would affect the efficacy or safety analysis of the drug. 9) Any medical or mental illness or abnormal laboratory parameters that the investigator believes will interfere with the participant's participation in the study or with the interpretation of the study results. 10) For any other reason, the investigator does not consider it appropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MRGPRX2; | — |
Secondary
| Measure | Time frame |
|---|---|
| Siglecs;CST-14; | — |
Countries
China
Contacts
Public ContactWang Zhao
The Second Affiliated Hospital, Health Science Center, Xi’an Jiaotong University
Outcome results
None listed