MedTrace Logo

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

NCT04718870 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2025-09-15

Study results available
· View outcomes & findings →

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.

Conditions

  • Dermatitis Atopic

Interventions

DRUG

Dupilumab SAR231893

Pharmaceutical form: solution for injection Route of administration: subcutaneous (SC)

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-19
Primary Completion
2022-09-07
Completion
2022-11-30
FDA Drug
Yes

Countries

  • United States
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04718870 on ClinicalTrials.gov