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Real-world efficacy and safety of dupilumab in chinese children aged 6 months to 5 years with severe atopic dermatitis: a single-centre, prospective, open-label study

Real-world efficacy and safety of dupilumab in chinese children aged 6 months to 5 years with severe atopic dermatitis: a single-centre, prospective, open-label study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200063385
Enrollment
Unknown
Registered
2022-09-05
Start date
2022-09-05
Completion date
Unknown
Last updated
2023-04-17

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
0.5 Years to 5 Years

Inclusion criteria

Inclusion criteria: 1. 6 months 50 points or EASI score > 20 points or IGA >= 4 points; 4. Poor response or intolerance to at least one topical drug (such as glucocorticoid, calcineurin inhibitor, phosphodiesterase inhibitor, etc.) in recent 6 months; 5. The guardian has signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Older than 6 years old; 2. Active chronic or acute infection requires systemic antibiotics and antiviral therapy within two weeks before the baseline visit;Patients treated with drugs, antigenic drugs or antifungal drugs were treated with TCI within 2 weeks before the baseline visit; 3. Patients who are vaccinated or ready to be vaccinated with live vaccine or attenuated live vaccine within 4 weeks; 4. Patients with primary / secondary immunodeficiency or suspected immunodeficiency; 5. Except for patients with genetic metabolic diseases, seborrheic dermatitis and other diseases that need to be identified; 6. Those who are allergic to doprilumab and any of its components; 7. According to the judgment of the researcher, the supervisor is untrustworthy or has poor compliance.

Design outcomes

Primary

MeasureTime frame
Eczema Area and Severity Index (EASI);Investigator Global Assessment (IGA) 0 or 1;

Secondary

MeasureTime frame
SCORing of Atopic Dermatitis;Patient-reported Outcome of Eczema Mesure Score;The Children's Dermatitis Quality of Life Index;Infants Dermatitis Quality of Life Index;Peak Pruritus Numerical Rating Scale (NRS);Atopic Dermatitis Control Tool;

Countries

China

Contacts

Public ContactHua Wang

Children's Hospital of Chongqing Medical University

huawang@hospital.cqmu.edu.cn+86 15123380348

Outcome results

None listed

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