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NCT04447417 · ClinicalTrials.gov registry record · Phase 4
Dupilumab Skin Barrier Function Study in Atopic Dermatitis
A Phase 4 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 4
- Development phase
- 52
- Enrollment target
NCT04447417: Completed Phase 4 study, sponsored by Sanofi.
NCT04447417 is a Phase 4 study that has completed, run by Sanofi. The registered enrollment target is 52 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04447417, a Phase 4 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 52 participants
- Enrollment target
Study 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.
Primary Outcome
TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize skin barrier function (SBF). TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. Lesional skin (LS) areas for TEWL assessment and STS was identified at Baseline ('predefined skin area'). Within the predefined LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measur
Interventions
- DRUG Dupilumab SAR231893
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2020-07-16 |
| Est. Completion | 2021-06-17 |
| Phase | Phase 4 |
What the finished NCT04447417 record still lists
NCT04447417 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Dupilumab SAR231893 is the first listed.
NCT04447417 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04447417 about?
NCT04447417 is a clinical study titled "Dupilumab Skin Barrier Function Study in Atopic Dermatitis". 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 chang...
What is the current status of trial NCT04447417?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 52 participants. The study started on 2020-07-16. Estimated completion is 2021-06-17.
What interventions are being tested in trial NCT04447417?
The interventions under investigation include: Dupilumab SAR231893 (DRUG).
Who is sponsoring clinical trial NCT04447417?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04447417's enrollment target sits among peer trials
52 1233rd of 2000 higher than 752 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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