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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 is a Phase 4 study that was terminated before completion, run by Boston University. The registered enrollment target is 72 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05200403
The ClinicalTrials.gov registry entry for NCT05200403 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston University, which has 185 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Crisaborole 2% is the first listed.
NCT05200403 reports 0 study locations.
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.
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