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NCT06192563
A Study to Observe How Adolescent Patients With Severe Atopic Dermatitis Despite Less Extensive Skin Lesions (Eczema Area and Severity Index Score < 16) Respond to Dupilumab Treatment
Conditions: Dermatitis Atopic
Sex: All
Ages: 12 Years – 17 Years
Healthy volunteers: No
Enrollment: 150
Sponsor: Sanofi
Location: Investigational Site Number: 002 Bologna
Summary
In adolescents treated with dupilumab, clinical trials showed significant improvement of atopic dermatitis (AD) signs and symptoms, with a good safety profile. In these clinical trials, only patients with Eczema Area and Severity Index (EASI) score greater than or equal to (≥) 16 were enrolled, and effectiveness on sensitive/visible areas was not specifically evaluated. Further data about the effectiveness of dupilumab in adolescent participants with moderate to mild EASI score and severe itching and/or localized AD are therefore necessary to better understand the potential clinical benefits of dupilumab in these populations.
This is an Italian multicenter, 52-week observational (non-interventional) study which will collect data on the characteristics of adolescent (aged 12 to 17 years) participants who suffer from severe AD with EASI score less than (\
Eligibility Criteria
Inclusion Criteria:
* Male or female, aged between 12 and 17 years at the baseline visit
* Patients with AD who have been prescribed dupilumab according to Agenzia Italiana del Farmaco (AIFA) reimbursement criteria and fulfilling the following criteria:
Patients with EASI\
Source: ClinicalTrials.gov (NCT06192563). StuddyBuddy aggregates publicly available trial information.