Can a biologic drug heal the skin barrier in kids with eczema?
NCT ID NCT04718870
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study looked at how dupilumab, an injectable biologic drug, affects the skin barrier in 41 children aged 6 to 12 with moderate to severe atopic dermatitis (eczema). Researchers measured water loss through the skin after removing thin layers with tape to assess barrier function. The goal was to see if dupilumab improves the skin's ability to retain moisture.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dupilumab (a biologic drug given as an injection)
- What this could lead to
- If successful, this could show that dupilumab helps repair the skin barrier in children with eczema, potentially improving long-term skin health.
- What could go wrong
- This is a small, early-phase study with only 41 participants, so results may not apply to all children. It focuses on a skin measurement (water loss) rather than direct symptom relief.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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41 people
The number who actually took part.
- Started
-
Feb 2021
- Finished
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Nov 2022
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 to 11 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 to- individuals 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Investigational Site Number :8260001
Sheffield, S10 2TH, United Kingdom
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Investigational Site Number :8400001
Denver, Colorado, 80206, United States
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Investigational Site Number :8400002
Los Angeles, California, 90027, United States
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