NCT04718870

Dupilumab-PEdiatric Skin Barrier Function and LIpidomics STudy in Patients With Atopic Dermatitis

Open-label Exploratory Study to Evaluate the Effect of Dupilumab on Skin Barrier Function in Pediatric Patients With Moderate to Severe Atopic Dermatitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: Accepted

Summary

Primary Objective: \- Evaluate changes in skin barrier function with transepidermal water loss (TEWL) assessed after skin tape stripping (STS) in predefined lesional skin in pediatric participants with moderate to severe atopic dermatitis (AD) treated with dupilumab. Secondary Objectives: * Evaluate changes in skin barrier function with TEWL assessed after STS in predefined lesional and non-lesional skin in pediatric participants with moderate to severe AD treated with dupilumab in reference to normal skin of healthy volunteers. * Evaluate time course of change in skin barrier function with TEWL assessed before and after STS in predefined lesional and non-lesional skin in pediatric participants with moderate to severe AD during dupilumab treatment phase and follow-up period in reference to normal skin of healthy volunteers.

Detailed description

Total study duration including screening and follow-up was 32 weeks.

Conditions

• Dermatitis Atopic

Interventions

Type	Name	Description
DRUG	Dupilumab SAR231893	Pharmaceutical form: solution for injection Route of administration: subcutaneous (SC)

Timeline

• Start date: 2021-02-19
• Primary completion: 2022-09-07
• Completion: 2022-11-30
• First posted: 2021-01-22
• Last updated: 2025-09-15
• Results posted: 2023-10-17

Locations

3 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study