Atopic dermatitis
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Gender unlimited; 2.Aged 18 to 70 years; 3. Meet the Hanifin-Rajka diagnostic criteria (see appendix 1), exclude infection, tumor and other connective tissue diseases and diagnose AD patients. 4. Meet the SCORAD score of =40 points or EASI index =10 points (see Annex 2) during the screening period; 5. Those who signed the informed consent form voluntarily participated in this project and were able to complete the follow-up as required.
Exclusion criteria
Exclusion criteria: 1. Suffering from malignant tumor or a history of malignant tumor within 5 years before screening; 2. There are other inflammatory skin diseases that may interfere with the evaluation of efficacy, including but not limited to psoriasis, parapsoriasis, eosinophilic dermatitis, seborrheic dermatitis, contact dermatitis, etc.; 3. Patients with serious heart, brain, lung, liver, kidney, blood and other important organ system diseases, and the researchers believe that they are not suitable to participate in this study; 4. Received systemic glucocorticoid, tripterygium, cyclosporine, methotrexate and other immunosuppressive therapy within 4 weeks before the first transplantation of the study, or received biological agent therapy within 3 months, such as Dupril Uzumumab and omalizumab, etc.; 5. Those who have used antimicrobial drugs, probiotics/meta-preparations, therapy to regulate intestinal microecology, and other drugs that have a greater impact on intestinal flora within 4 weeks; 6. Known active or recurrent serious infection such as active tuberculosis; 7. Congenital immunodeficiency or congenital immunosuppression; 8. Patients with drug addiction, alcohol abuse or mental disorders, unable to cooperate or adhere to treatment, and poor predictability; 9. Pregnant women, pregnant women and lactating women; 10. The patient is participating in other clinical trials at the same time; 11. Any person who is considered inappropriate by the investigator to participate in this trial for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Eczema Area and Severity Index 50 Response Ratio; | — |
Secondary
| Measure | Time frame |
|---|---|
| Eczema Area and Severity Index 75 Response Ratio;Eczema Area and Severity Index;Atopic Dermatitis Score;Overall Investigator Assessment;Atopic Dermatitis Evaluation Tool;Dermatology Life Quality Index;Visual Analog Pain Score;Patient Eczema Self-Examination Rating Scale;Hospital Anxiety and Depression Scale;The proportion of Th cell subsets and the changes of serum effector cytokines;total IgE; | — |
Countries
China
Contacts
Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences, Peking Union Medical College