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A single-center clinical cohort study of dupilumab in the treatment of moderate-to-severe atopic dermatitis aged 6 years and older

A single-center clinical cohort study of dupilumab in the treatment of moderate-to-severe atopic dermatitis aged 6 years and older

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053167
Enrollment
Unknown
Registered
2021-11-13
Start date
2021-12-15
Completion date
Unknown
Last updated
2022-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis (AD)

Interventions

Sponsors

Children's Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 18 Years

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

MeasureTime 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

Public ContactLuo Xiaoyan

Children's Hospital of Chongqing Medical University

luoxycq@hotmail.com+86 13012381671

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026