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NCT05200403 · ClinicalTrials.gov registry record · Phase 4
Improvement In Scratch Behavior And Sleep In Patients With Atopic Dermatitis
A Phase 4 study, sponsored by Boston University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 72
- Enrollment target
NCT05200403: Clinical Trial Phase 4 study, sponsored by Boston University.
NCT05200403 is a Phase 4 study that was terminated before completion, run by Boston University. The registered enrollment target is 72 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05200403, a Phase 4 study, was terminated before completion, sponsored by Boston University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 72 participants
- Enrollment target
Study Summary
This single blind study is to primarily evaluate wearable devices and Observer Reported Itch Assessment in children to assess reduction of itch and night-time scratch in response to Crisaborole treatment vs. vehicle treatment (active control comparator without crisaborole) in children with atopic dermatitis (AD). Participants, age 3 months to 11 years with symptomatic mild to moderate AD, along with their primary caregivers will be recruited. The goal of this study is to more fully evaluate the rapid onset of night-time itch and scratch relief, as well as improvements in sleep following treatment with Crisaborole in comparison to vehicle treatment in children with AD. the study will also assess the quality of life (QoL) and sleep within the associated caregivers.
Primary Outcome
The number of nighttime scratching episodes will be recorded on by accelerometry.
Interventions
- DRUG Crisaborole 2%
- DRUG Vehicle treatment
- DEVICE Accelerometry device for children
- DEVICE Accelerometry device for adult caregivers
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2022-07-26 |
| Est. Completion | 2024-02-15 |
| Phase | Phase 4 |
Why NCT05200403 stopped before completion
NCT05200403 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 4 interventions - of which Crisaborole 2% is the first listed.
NCT05200403 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05200403 about?
NCT05200403 is a clinical study titled "Improvement In Scratch Behavior And Sleep In Patients With Atopic Dermatitis". This single blind study is to primarily evaluate wearable devices and Observer Reported Itch Assessment in children to assess reduction of itch and night-time scratch in response to Crisaborole treatment vs. vehicle treatment (active control comparator without crisaborole) in children with atopic de...
What is the current status of trial NCT05200403?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 72 participants. The study started on 2022-07-26. Estimated completion is 2024-02-15.
What interventions are being tested in trial NCT05200403?
The interventions under investigation include: Crisaborole 2% (DRUG), Vehicle treatment (DRUG), Accelerometry device for children (DEVICE), Accelerometry device for adult caregivers (DEVICE).
Who is sponsoring clinical trial NCT05200403?
This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05200403's enrollment target sits among peer trials
72 1035th of 2000 higher than 961 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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