This study is currently not recruiting participants.

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

Investigation of Skin Barrier Function in Pediatric Dermatology

Not Recruiting
6 years - 11 years
All
Phase 4
41 participants needed

Study Overview

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.

Study Details

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

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Dermatitis Atopic
  • Age: 6 years - 11 years
  • Gender: All

Inclusion criteria :

  • Participant must be between >=6 to <12 years of age (inclusive), at the time of signing the informed consent
  • 15 kg <= body weight <60 kg.

Atopic dermatitis participants:

  • Male or female pediatric participants.
  • Participants with AD diagnosis according to Hanifin and Rajka criteria at least 1 year before screening.
  • Investigator Global Assessment (IGA) score of >=3 (for US participants) or IGA >=4 (for EU participants) at screening (on the 0-4 scale) depending on approved label indication in the country.
  • Participants with moderate to severe AD those were eligible to be treated with dupilumab according to product label.
  • Participants with AD must have had active lesions on the upper limbs or lower limbs (including trunk, if needed), with severity for lesion erythema or edema/papulation >=2 at screening on the 0-3 scale of the Individual Signs Score.
  • Participants should have had a non-lesional (normal looking) skin area 4 centimeter (cm) from the edge of the lesional area. If unable to identify non-lesional skin 4 cm from the lesional area, it was acceptable to identify normal looking skin as close to the lesion as possible.

Healthy volunteers:

  • Age and gender matched (match on age ±2 years) to a selected AD participant by study site.

Exclusion criteria:

  • Previous treatment with dupilumab within 6 months prior to screening.
  • Skin conditions other than AD that can confound assessments in the area of TEWL assessments in the opinion of the Investigator (i.e., skin atrophy, ichthyosis, tinea infection, contact dermatitis).
  • Cracked, crusted, oozing, or bleeding AD lesions in the designated lesional assessment area leaving insufficient skin that was adequate for TEWL assessments.
  • Hypersensitivity to the active substance or to any of the excipients of dupilumab.
  • Ocular disorder that in the opinion of the Investigator could adversely affect the individual's risk for study participation. Examples include -but are not limited toindividuals with a history of active cases of herpes keratitis; Sjogren's syndrome, keratoconjunctivitis sicca, or individuals with ocular conditions that require the use of ocular corticosteroids or cyclosporine.
  • Healthy volunteers with a personal history of an atopic condition.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

This study investigates atopic dermatitis in children. It focuses on understanding changes in the skin's barrier function.

The study evaluates how effective a treatment is in maintaining the skin's barrier. It looks at the skin's ability to hold moisture and protect against external factors.

  • Who can participate: Children aged 6 to 11 years with moderate to severe atopic dermatitis are eligible. Participants must meet specific health criteria, including a body weight between 15 kg and 60 kg.
  • Study details: Participants will receive an investigational medication. Some participants may receive a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine.
  • Study timelines: The study will last 32 weeks.
Updated on 23 May 2026. Study ID: NCT04718870