Trial · NCT05200403
Improvement In Scratch Behavior And Sleep In Patients With Atopic Dermatitis
NCT05200403, Phase 4, Terminated, Boston University; results first posted 2025-03-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Improvement In Scratch Behavior And Sleep In Patients With Atopic Dermatitis. Trials, record NCT05200403. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05200403
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Improvement In Scratch Behavior And Sleep In Patients With Atopic Dermatitis
- NCT number
- NCT05200403
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 72 participants, actual
- Lead sponsor
- Boston University
- Conditions
- Atopic Dermatitis
- Interventions
- Crisaborole 2%, Vehicle treatment, Accelerometry device for children, Accelerometry device for adult caregivers
- First posted
- 2022-01-20
- Last updated
- 2025-03-14
- Results first posted
- 2025-03-14
- Limitations and caveats
- Funding was stopped by grantor.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Children's Nighttime Scratching Episodes | 2 weeks | The number of nighttime scratching episodes will be recorded on by accelerometry. |
| Primary | Duration of Children's Nighttime Scratching Episodes | 2 weeks | The duration of nighttime scratching episodes will be recorded on by accelerometry. |
| Primary | Scratch Assessment by Adult Caregiver | 2 weeks | Adult caregivers will fill out the Observer Reported Itch Assessment (ORIA) which is a single question assessment to assess the severity of the child participant's itch. The minimum score of "0" indicates "no itch" and the maximum score of "10" indicates "worst itch imaginable." |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Children's Nighttime Scratching Episodes | 2 weeks | For the crisaborole group, there were 11 participants that had sufficient processable data. For the Vehicle group, there were 8 participants that had sufficient processable data. The rest were not included due to device malfunction, non-wear, or missing data. | scratch count per night | MEAN |
| PRIMARY | Duration of Children's Nighttime Scratching Episodes | 2 weeks | For the crisaborole group, there were 11 participants that had sufficient processable data. For the Vehicle group, there were 8 participants that had sufficient processable data. The rest were not included due to device malfunction, non-wear, or missing data. | minutes | MEAN |
| PRIMARY | Scratch Assessment by Adult Caregiver | 2 weeks | 1 participant from each group withdrew after visit 1, thus no at home data was collected. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Children's Nighttime Scratching Episodes | Crisaborole 2% | 93.04 | Standard Deviation 70.35 | scratch count per night | |
| Number of Children's Nighttime Scratching Episodes | Vehicle Arm | 116.85 | Standard Deviation 62.17 | scratch count per night | |
| Duration of Children's Nighttime Scratching Episodes | Crisaborole 2% | 7.04 | Standard Deviation 6.44 | minutes | |
| Duration of Children's Nighttime Scratching Episodes | Vehicle Arm | 8.63 | Standard Deviation 5.00 | minutes | |
| Scratch Assessment by Adult Caregiver | Crisaborole 2% | 3.91 | Standard Deviation 2.45 | score on a scale | |
| Scratch Assessment by Adult Caregiver | Vehicle Arm | 3.53 | Standard Deviation 2.05 | score on a scale |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Crisaborole 2% | 21 | |
| Overall Study | STARTED | Vehicle Arm | 15 | |
| Overall Study | STARTED | Caregiver | 36 | |
| Overall Study | COMPLETED | Crisaborole 2% | 17 | |
| Overall Study | COMPLETED | Vehicle Arm | 13 | |
| Overall Study | COMPLETED | Caregiver | 30 | |
| Overall Study | NOT COMPLETED | Crisaborole 2% | 4 | |
| Overall Study | NOT COMPLETED | Vehicle Arm | 2 | |
| Overall Study | NOT COMPLETED | Caregiver | 6 |
Source ClinicalTrials.gov
Adverse events3
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Overall Study | Skin and subcutaneous tissue disorders | Crisaborole 2% | 1 | 21 | 1 |
| other | Overall Study | Skin and subcutaneous tissue disorders | Vehicle Arm | 0 | 15 | 0 |
| other | Overall Study | Skin and subcutaneous tissue disorders | Caregiver | 0 | 36 | 0 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Crisaborole 2% | 0 | 21 |
| Total, all-cause mortality | Vehicle Arm | 0 | 15 |
| Total, all-cause mortality | Caregiver | 0 | 36 |
| Total, other adverse events | Crisaborole 2% | 1 | 21 |
| Total, other adverse events | Vehicle Arm | 0 | 15 |
| Total, other adverse events | Caregiver | 0 | 36 |
| Total, serious adverse events | Crisaborole 2% | 0 | 21 |
| Total, serious adverse events | Vehicle Arm | 0 | 15 |
| Total, serious adverse events | Caregiver | 0 | 36 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05200403
GET https://conductscience.org/api/trials/v1/NCT05200403/registered