NCT04447417

Dupilumab Skin Barrier Function Study in Atopic Dermatitis

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 12 Years – 65 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 pre-defined lesional skin in 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 pre-defined lesional and non-lesional skin in participants with moderate to severe AD treated with dupilumab in reference to normal skin of healthy volunteers. * Evaluate time course of skin barrier function with TEWL assessed before and after STS in pre-defined lesional and non-lesional skin in participants with moderate to severe AD treated with dupilumab in reference to normal skin of healthy volunteers.

Detailed description

The duration for each participant was a total of approximately 24 weeks.

Conditions

• Atopic Dermatitis

Interventions

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

Timeline

• Start date: 2020-07-16
• Primary completion: 2021-06-17
• Completion: 2021-06-17
• First posted: 2020-06-25
• Last updated: 2025-09-18
• Results posted: 2022-07-22

Locations

2 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study