Atopic Dermatitis
Conditions
Interventions
Treatment group:Dupilumab+TCS
Sponsors
Children's Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
6 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 6 years or above; 2. AD was diagnosed by Williams criteria, and was determined as moderate to severe AD by IgA, Scorad score combined with DLQI and NRS; 3. Baseline IgA >= 3, Scorad >= 25; Or although IgA 7 or DLQI > 10; 4. Poor local treatment control within 6 months prior to the baseline visit; 5. At least 7 days prior to the baseline visit, a stable dose of emollient was administered topically twice a day; 6. Medium and effective TCS should be used once a day for 2 weeks prior to baseline visit; 7. The guardian has signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Baseline weight < 15kg; 2. Use of immunosuppressant, immunomodulator, or live (attenuated) vaccine within 4 weeks prior to baseline visit; 3. Use of TCI within 2 weeks prior to baseline visit; 4. Immunodeficiency, serious systemic disease (such as heart, liver, kidney), malignant tumor; 5. Patients with an active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitic drugs, or antifungal agents within 2 weeks prior to baseline visit; 6. According to the researcher's judgment, the guardian is unreliable or poor in compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Eczema Area and Severity Index (EASI) (EASI 75) from Baseline;Investigator's Global Assessment 0/1; | — |
Secondary
| Measure | Time frame |
|---|---|
| The Scoring Atopic Dermatitis (SCORAD) score;Patient-reported outcome of eczema mesure;The Children's Dermatitis Quality of Life Index;Peak Pruritus Numerical Rating Scale (NRS); | — |
Countries
China
Contacts
Public ContactLuo Xiaoyan
Children's Hospital of Chongqing Medical University
Outcome results
None listed