drugset / Trial / NCT04447417

Dupilumab Skin Barrier Function Study in Atopic Dermatitis

NCT04447417

Phase 4 Completed 52 enrolled Sanofi Regeneron Pharmaceuticals · collab
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2020-07-16
Primary completion
2021-06-17
Completion
2021-06-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Dupilumab Monoclonal antibody 200 mg Subcutaneous
Subject Dupilumab Monoclonal antibody 300 mg Subcutaneous

Indications