Atopic Dermatitis
Conditions
Interventions
Lidocaine group:Subjects will receive Intravenous lidocaine for 4 weeks at a dose of 4mg/Kg/d. They will receive treatment for the first two weeks during their hospitalization, with a frequency of onc
Dupilumab group:Subjects will be treated with subcutaneous injection of dupilumab for 16 weeks. The first dose of 600mg/400mg (adjusted according to the patient s individual age and weight) will be in
Sponsors
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
12 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age between 12-70 years old, not limited to men and women. 2. Diagnosed as Atopic Dermatitis according to Hanifin & Rajka diagnostic criteria. 3. Investigator’s global assessment = 3 points. 4. Eczema area and severity index = 16. 5. Peak Pruritus Numerical Rating Scale = 4. 6. Body surface area = 10%. 7. Poor response to topical anti-inflammatory therapy or significant medical risk in applying topical anti-inflammatory therapy. 8. Subjects and their guardians have signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Uncontrolled severe infection, parasitic infection, active hepatitis B, active tuberculosis; 2. Recent use of treatment regimens that may have affected the observations of the study results: Use of systemic therapy within 4 weeks prior to baseline (cyclosporin A, azathioprine, methotrexate, systemic glucocorticoids, etc.) Received phototherapy within 12 weeks prior to baseline Use of biologics within 12 weeks prior to baseline Use of lidocaine within 12 weeks prior to baseline 3. Recently participated in other drug research programs. 4. Past medical history of immunodeficiency disease. 5. Past medical history of arrhythmia, heart failure, severe heart block (second or third degree). 6. Abnormal indicators of liver and kidney function. (AST, ALT, bilirubin, alkaline phosphatase, uric acid, or serum creatinine values greater than the upper limit of normal) 7. Subjects have other skin diseases that may interfere with the observation of study results. 8. History of allergy to dupilumab, lidocaine, and other local anesthetics. 9. Subjects are pregnant, breastfeeding or have family planning during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Eczema area and severity index 50 Response Ratio; | — |
Secondary
| Measure | Time frame |
|---|---|
| Peak Pruritus Numerical Rating Scale;Eczema area and severity index;Investigator’s global assessment;Dermatology Life Quality Index;The Patient Oriented Eczema Measure; | — |
Countries
China
Contacts
Public ContactYao Zhirong
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed