Atopic Dermatitis (AD)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 6 years and above; 2. The Williams standard is diagnosed as AD, and the IGA and SCORAD scores combined with DLQI and NRS are comprehensively judged to be moderate to severe AD; 3. Baseline IGA>=3 points, SCORAD>=25; or although IGA7 or DLQI>10; 4. Poor local treatment control within 6 months before the baseline visit; 5. Topical application of a stable dose of emollient twice daily for at least 7 days prior to the baseline visit; 6. Within 2 weeks before the baseline visit, use medium-acting TCS once a day; 7. The guardian has signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Aged over 18 years; 2. Baseline weight <15kg; 3. The use of immunosuppressants, immunomodulators or live (attenuated) vaccines within 4 weeks before the baseline visit; 4. Treatment with TCI within 2 weeks before the baseline visit; 5. Patients with immunodeficiency, serious systemic diseases (such as heart, liver, kidney), malignant tumors; 6. Those with active chronic or acute infection who need to be treated with systemic antibiotics, antiviral, antiparasitic or antifungal drugs within 2 weeks before the baseline visit; 7. According to the judgment of the researcher, the guardian is unreliable or has poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Eczema Area and Severity Index (EASI);Investigator Global Assessment (IGA) 0 or 1;Patient-reported Outcome of Eczema Mesure Score;The Children's Dermatitis Quality of Life Index;Peak Pruritus Numerical Rating Scale (NRS); | — |
Countries
China
Contacts
Children's Hospital of Chongqing Medical University