NCT06238765

CorEvitas International Adolescent Atopic Dermatitis (AD) Drug Safety and Effectiveness Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: CorEvitas · Network
• Sex: All
• Age: 12 Years – 15 Years
• Healthy volunteers: Accepted

Summary

Prospective observational registry for an adolescent cohort with AD under the care of a dermatology provider. Approximately 1500 subjects and 75 clinical sites in North America and select European countries will be recruited to participate with no defined upper limit for either target.

Detailed description

The objective of the registry is to create a cohort of adolescent subjects with AD to evaluate the long-term safety and effectiveness of AD treatments. Data collected will be used to better characterize the natural history of the disease and to extensively evaluate the effectiveness and safety of medications approved for the treatment of AD to support ongoing risk-benefit evaluation by drug manufacturers and regulators. Further, data collected will inform clinical decision making by patients and treating providers. This will be done through standardized data collection including validated instruments for patient-reported outcomes (PROs) and clinician-reported outcomes (ClinROs), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization patterns. This provides an opportunity to evaluate other aspects of the disease and its treatment, including but not limited to clinical and drug cost-effectiveness, health care resource utilization, and subject adherence.

Conditions

• Atopic Dermatitis

Timeline

• Start date: 2023-12-02
• Primary completion: 2099-12-31
• Completion: 2099-12-31
• First posted: 2024-02-02
• Last updated: 2026-02-09

Locations

1 site across 1 country: United States