NCT03687359

Observational Evaluation of Atopic Dermatitis in Pediatric Patients

Prospective, Observational, Longitudinal Study in Pediatric Patients With Moderate to Severe Atopic Dermatitis Whose Disease is Not Adequately Controlled With Topical Prescription Therapies or When Those Therapies Are Not Medically Advisable

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,860 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 0 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

Primary Objectives: * To describe the characteristics of pediatric patients with moderate to severe atopic dermatitis (AD) whose disease is not adequately controlled with topical therapies or when those therapies are not medically advisable. * To evaluate the time-course of AD and selected atopic comorbidities. Secondary Objectives: * To characterize disease burden and unmet need. * To describe real-world treatment patterns (eg, dosing regimens, treatment duration, and reasons for discontinuation and/or switching). * To document the real-world effectiveness and safety of treatments.

Detailed description

The study duration is 120 months.

Conditions

• Dermatitis Atopic

Interventions

Type	Name	Description
OTHER	Standard of care	Treatment as per standard practice

Timeline

• Start date: 2019-08-15
• Primary completion: 2035-07-23
• Completion: 2035-07-23
• First posted: 2018-09-27
• Last updated: 2025-08-15

Locations

182 sites across 20 countries: United States, Argentina, Australia, Brazil, Canada, China, Colombia, Denmark, France, Greece, Israel, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, South Korea, Spain

Regulatory

• FDA-regulated drug study