Trial Outcomes & Findings for Improvement In Scratch Behavior And Sleep In Patients With Atopic Dermatitis (NCT NCT05200403)
NCT ID: NCT05200403
Last Updated: 2025-03-14
Results Overview
The number of nighttime scratching episodes will be recorded on by accelerometry.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
72 participants
Primary outcome timeframe
2 weeks
Results posted on
2025-03-14
Participant Flow
Participant milestones
| Measure |
Crisaborole 2%
Adult caregivers of children participants will be asked to apply a thin even-layer of Crisaborole (2%) twice daily for 2 weeks.
Crisaborole 2%: The adult caregiver will apply a thin layer of Crisaborole 2% topically on their child participant twice a day for 2 weeks.
Accelerometry device for children: Children participants will wear two wrist worn (or wrist worn AND ankle worn for 3 months up to \<2 years) accelerometry devices. Devices will be optional for child participants who have active AD on location of device placement, with a minimum of at least one wrist device needed for enrollment.
Accelerometry device for adult caregivers: Adult caregiver participants will wear two accelerometry devices (one on each wrist) and complete daily assessments related to scratching, sleeping habits, pain, AD severity, quality of life, and device comfort questionnaires.
|
Vehicle Arm
Adult caregivers of children participants will be asked to apply a thin even-layer of vehicle treatment twice daily for 2 weeks.
Vehicle treatment: The adult caregiver will apply a thin layer of the vehicle treatment topically on their child participant twice a day for 2 weeks. The vehicle treatment is made of excipients of crisaborole ointment (non-medicated ointment).
Accelerometry device for children: Children participants will wear two wrist worn (or wrist worn AND ankle worn for 3 months up to \<2 years) accelerometry devices. Devices will be optional for child participants who have active AD on location of device placement, with a minimum of at least one wrist device needed for enrollment.
Accelerometry device for adult caregivers: Adult caregiver participants will wear two accelerometry devices (one on each wrist) and complete daily assessments related to scratching, sleeping habits, pain, AD severity, quality of life, and device comfort questionnaires.
|
Caregiver
Caregivers of Child Participants; caregivers did not receive treatment with crisaborole or vehicle.
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
15
|
36
|
|
Overall Study
COMPLETED
|
17
|
13
|
30
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
6
|
Reasons for withdrawal
| Measure |
Crisaborole 2%
Adult caregivers of children participants will be asked to apply a thin even-layer of Crisaborole (2%) twice daily for 2 weeks.
Crisaborole 2%: The adult caregiver will apply a thin layer of Crisaborole 2% topically on their child participant twice a day for 2 weeks.
Accelerometry device for children: Children participants will wear two wrist worn (or wrist worn AND ankle worn for 3 months up to \<2 years) accelerometry devices. Devices will be optional for child participants who have active AD on location of device placement, with a minimum of at least one wrist device needed for enrollment.
Accelerometry device for adult caregivers: Adult caregiver participants will wear two accelerometry devices (one on each wrist) and complete daily assessments related to scratching, sleeping habits, pain, AD severity, quality of life, and device comfort questionnaires.
|
Vehicle Arm
Adult caregivers of children participants will be asked to apply a thin even-layer of vehicle treatment twice daily for 2 weeks.
Vehicle treatment: The adult caregiver will apply a thin layer of the vehicle treatment topically on their child participant twice a day for 2 weeks. The vehicle treatment is made of excipients of crisaborole ointment (non-medicated ointment).
Accelerometry device for children: Children participants will wear two wrist worn (or wrist worn AND ankle worn for 3 months up to \<2 years) accelerometry devices. Devices will be optional for child participants who have active AD on location of device placement, with a minimum of at least one wrist device needed for enrollment.
Accelerometry device for adult caregivers: Adult caregiver participants will wear two accelerometry devices (one on each wrist) and complete daily assessments related to scratching, sleeping habits, pain, AD severity, quality of life, and device comfort questionnaires.
|
Caregiver
Caregivers of Child Participants; caregivers did not receive treatment with crisaborole or vehicle.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
6
|
Baseline Characteristics
Observer Reported Itch Assessment were not collected for Caregiver Arm/Group.
Baseline characteristics by cohort
| Measure |
Crisaborole 2%
n=21 Participants
Adult caregivers of children participants will be asked to apply a thin even-layer of Crisaborole (2%) twice daily for 2 weeks.
Crisaborole 2%: The adult caregiver will apply a thin layer of Crisaborole 2% topically on their child participant twice a day for 2 weeks.
Accelerometry device for children: Children participants will wear two wrist worn (or wrist worn AND ankle worn for 3 months up to \<2 years) accelerometry devices. Devices will be optional for child participants who have active AD on location of device placement, with a minimum of at least one wrist device needed for enrollment.
Accelerometry device for adult caregivers: Adult caregiver participants will wear two accelerometry devices (one on each wrist) and complete daily assessments related to scratching, sleeping habits, pain, AD severity, quality of life, and device comfort questionnaires.
|
Vehicle Arm
n=15 Participants
Adult caregivers of children participants will be asked to apply a thin even-layer of vehicle treatment twice daily for 2 weeks.
Vehicle treatment: The adult caregiver will apply a thin layer of the vehicle treatment topically on their child participant twice a day for 2 weeks. The vehicle treatment is made of excipients of crisaborole ointment (non-medicated ointment).
Accelerometry device for children: Children participants will wear two wrist worn (or wrist worn AND ankle worn for 3 months up to \<2 years) accelerometry devices. Devices will be optional for child participants who have active AD on location of device placement, with a minimum of at least one wrist device needed for enrollment.
Accelerometry device for adult caregivers: Adult caregiver participants will wear two accelerometry devices (one on each wrist) and complete daily assessments related to scratching, sleeping habits, pain, AD severity, quality of life, and device comfort questionnaires.
|
Caregiver
n=36 Participants
Caregivers of Child Participants; caregivers did not receive treatment with crisaborole or vehicle.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
21 Participants
n=21 Participants
|
15 Participants
n=15 Participants
|
0 Participants
n=36 Participants
|
36 Participants
n=72 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=21 Participants
|
0 Participants
n=15 Participants
|
36 Participants
n=36 Participants
|
36 Participants
n=72 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=21 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=72 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=21 Participants
|
6 Participants
n=15 Participants
|
34 Participants
n=36 Participants
|
51 Participants
n=72 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=21 Participants
|
9 Participants
n=15 Participants
|
2 Participants
n=36 Participants
|
21 Participants
n=72 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=21 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=72 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=21 Participants
|
0 Participants
n=15 Participants
|
2 Participants
n=36 Participants
|
3 Participants
n=72 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=21 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=72 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=21 Participants
|
9 Participants
n=15 Participants
|
19 Participants
n=36 Participants
|
40 Participants
n=72 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=21 Participants
|
4 Participants
n=15 Participants
|
10 Participants
n=36 Participants
|
19 Participants
n=72 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=21 Participants
|
1 Participants
n=15 Participants
|
1 Participants
n=36 Participants
|
4 Participants
n=72 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=21 Participants
|
1 Participants
n=15 Participants
|
4 Participants
n=36 Participants
|
6 Participants
n=72 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=21 Participants
|
15 participants
n=15 Participants
|
36 participants
n=36 Participants
|
72 participants
n=72 Participants
|
|
Observer Reported Itch Assessment (ORIA)
|
5.48 score on a scale
STANDARD_DEVIATION 2.09 • n=21 Participants • Observer Reported Itch Assessment were not collected for Caregiver Arm/Group.
|
6.61 score on a scale
STANDARD_DEVIATION 2.31 • n=15 Participants • Observer Reported Itch Assessment were not collected for Caregiver Arm/Group.
|
—
|
6.07 score on a scale
STANDARD_DEVIATION 2.30 • n=36 Participants • Observer Reported Itch Assessment were not collected for Caregiver Arm/Group.
|
|
Number of children's nighttime scratching episodes
|
104.83 scratch count per night
STANDARD_DEVIATION 54.49 • n=11 Participants • 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. The number of children's nighttime scratching episodes were not collected for the Caregiver Arm/Group.
|
103.82 scratch count per night
STANDARD_DEVIATION 69.22 • n=8 Participants • 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. The number of children's nighttime scratching episodes were not collected for the Caregiver Arm/Group.
|
—
|
104.33 scratch count per night
STANDARD_DEVIATION 61.86 • n=19 Participants • 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. The number of children's nighttime scratching episodes were not collected for the Caregiver Arm/Group.
|
|
Duration of children's nighttime scratching episodes
|
7.81 minutes
STANDARD_DEVIATION 4.33 • n=11 Participants • 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. The duration of children's nighttime scratching episodes were not collected for the Caregiver Arm/Group.
|
7.44 minutes
STANDARD_DEVIATION 5.50 • n=8 Participants • 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. The duration of children's nighttime scratching episodes were not collected for the Caregiver Arm/Group.
|
—
|
7.63 minutes
STANDARD_DEVIATION 4.92 • n=19 Participants • 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. The duration of children's nighttime scratching episodes were not collected for the Caregiver Arm/Group.
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: 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.
The number of nighttime scratching episodes will be recorded on by accelerometry.
Outcome measures
| Measure |
Crisaborole 2%
n=11 Participants
Adult caregivers of children participants will be asked to apply a thin even-layer of Crisaborole (2%) twice daily for 2 weeks.
Crisaborole 2%: The adult caregiver will apply a thin layer of Crisaborole 2% topically on their child participant twice a day for 2 weeks.
Accelerometry device for children: Children participants will wear two wrist worn (or wrist worn AND ankle worn for 3 months up to \<2 years) accelerometry devices. Devices will be optional for child participants who have active AD on location of device placement, with a minimum of at least one wrist device needed for enrollment.
Accelerometry device for adult caregivers: Adult caregiver participants will wear two accelerometry devices (one on each wrist) and complete daily assessments related to scratching, sleeping habits, pain, AD severity, quality of life, and device comfort questionnaires.
|
Vehicle Arm
n=8 Participants
Adult caregivers of children participants will be asked to apply a thin even-layer of vehicle treatment twice daily for 2 weeks.
Vehicle treatment: The adult caregiver will apply a thin layer of the vehicle treatment topically on their child participant twice a day for 2 weeks. The vehicle treatment is made of excipients of crisaborole ointment (non-medicated ointment).
Accelerometry device for children: Children participants will wear two wrist worn (or wrist worn AND ankle worn for 3 months up to \<2 years) accelerometry devices. Devices will be optional for child participants who have active AD on location of device placement, with a minimum of at least one wrist device needed for enrollment.
Accelerometry device for adult caregivers: Adult caregiver participants will wear two accelerometry devices (one on each wrist) and complete daily assessments related to scratching, sleeping habits, pain, AD severity, quality of life, and device comfort questionnaires.
|
|---|---|---|
|
Number of Children's Nighttime Scratching Episodes
|
93.04 scratch count per night
Standard Deviation 70.35
|
116.85 scratch count per night
Standard Deviation 62.17
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: 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.
The duration of nighttime scratching episodes will be recorded on by accelerometry.
Outcome measures
| Measure |
Crisaborole 2%
n=11 Participants
Adult caregivers of children participants will be asked to apply a thin even-layer of Crisaborole (2%) twice daily for 2 weeks.
Crisaborole 2%: The adult caregiver will apply a thin layer of Crisaborole 2% topically on their child participant twice a day for 2 weeks.
Accelerometry device for children: Children participants will wear two wrist worn (or wrist worn AND ankle worn for 3 months up to \<2 years) accelerometry devices. Devices will be optional for child participants who have active AD on location of device placement, with a minimum of at least one wrist device needed for enrollment.
Accelerometry device for adult caregivers: Adult caregiver participants will wear two accelerometry devices (one on each wrist) and complete daily assessments related to scratching, sleeping habits, pain, AD severity, quality of life, and device comfort questionnaires.
|
Vehicle Arm
n=8 Participants
Adult caregivers of children participants will be asked to apply a thin even-layer of vehicle treatment twice daily for 2 weeks.
Vehicle treatment: The adult caregiver will apply a thin layer of the vehicle treatment topically on their child participant twice a day for 2 weeks. The vehicle treatment is made of excipients of crisaborole ointment (non-medicated ointment).
Accelerometry device for children: Children participants will wear two wrist worn (or wrist worn AND ankle worn for 3 months up to \<2 years) accelerometry devices. Devices will be optional for child participants who have active AD on location of device placement, with a minimum of at least one wrist device needed for enrollment.
Accelerometry device for adult caregivers: Adult caregiver participants will wear two accelerometry devices (one on each wrist) and complete daily assessments related to scratching, sleeping habits, pain, AD severity, quality of life, and device comfort questionnaires.
|
|---|---|---|
|
Duration of Children's Nighttime Scratching Episodes
|
7.04 minutes
Standard Deviation 6.44
|
8.63 minutes
Standard Deviation 5.00
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: 1 participant from each group withdrew after visit 1, thus no at home data was collected.
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."
Outcome measures
| Measure |
Crisaborole 2%
n=20 Participants
Adult caregivers of children participants will be asked to apply a thin even-layer of Crisaborole (2%) twice daily for 2 weeks.
Crisaborole 2%: The adult caregiver will apply a thin layer of Crisaborole 2% topically on their child participant twice a day for 2 weeks.
Accelerometry device for children: Children participants will wear two wrist worn (or wrist worn AND ankle worn for 3 months up to \<2 years) accelerometry devices. Devices will be optional for child participants who have active AD on location of device placement, with a minimum of at least one wrist device needed for enrollment.
Accelerometry device for adult caregivers: Adult caregiver participants will wear two accelerometry devices (one on each wrist) and complete daily assessments related to scratching, sleeping habits, pain, AD severity, quality of life, and device comfort questionnaires.
|
Vehicle Arm
n=14 Participants
Adult caregivers of children participants will be asked to apply a thin even-layer of vehicle treatment twice daily for 2 weeks.
Vehicle treatment: The adult caregiver will apply a thin layer of the vehicle treatment topically on their child participant twice a day for 2 weeks. The vehicle treatment is made of excipients of crisaborole ointment (non-medicated ointment).
Accelerometry device for children: Children participants will wear two wrist worn (or wrist worn AND ankle worn for 3 months up to \<2 years) accelerometry devices. Devices will be optional for child participants who have active AD on location of device placement, with a minimum of at least one wrist device needed for enrollment.
Accelerometry device for adult caregivers: Adult caregiver participants will wear two accelerometry devices (one on each wrist) and complete daily assessments related to scratching, sleeping habits, pain, AD severity, quality of life, and device comfort questionnaires.
|
|---|---|---|
|
Scratch Assessment by Adult Caregiver
|
3.91 score on a scale
Standard Deviation 2.45
|
3.53 score on a scale
Standard Deviation 2.05
|
Adverse Events
Crisaborole 2%
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Vehicle Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Caregiver
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Crisaborole 2%
n=21 participants at risk
Adult caregivers of children participants will be asked to apply a thin even-layer of Crisaborole (2%) twice daily for 2 weeks.
Crisaborole 2%: The adult caregiver will apply a thin layer of Crisaborole 2% topically on their child participant twice a day for 2 weeks.
Accelerometry device for children: Children participants will wear two wrist worn (or wrist worn AND ankle worn for 3 months up to \<2 years) accelerometry devices. Devices will be optional for child participants who have active AD on location of device placement, with a minimum of at least one wrist device needed for enrollment.
Accelerometry device for adult caregivers: Adult caregiver participants will wear two accelerometry devices (one on each wrist) and complete daily assessments related to scratching, sleeping habits, pain, AD severity, quality of life, and device comfort questionnaires.
|
Vehicle Arm
n=15 participants at risk
Adult caregivers of children participants will be asked to apply a thin even-layer of vehicle treatment twice daily for 2 weeks.
Vehicle treatment: The adult caregiver will apply a thin layer of the vehicle treatment topically on their child participant twice a day for 2 weeks. The vehicle treatment is made of excipients of crisaborole ointment (non-medicated ointment).
Accelerometry device for children: Children participants will wear two wrist worn (or wrist worn AND ankle worn for 3 months up to \<2 years) accelerometry devices. Devices will be optional for child participants who have active AD on location of device placement, with a minimum of at least one wrist device needed for enrollment.
Accelerometry device for adult caregivers: Adult caregiver participants will wear two accelerometry devices (one on each wrist) and complete daily assessments related to scratching, sleeping habits, pain, AD severity, quality of life, and device comfort questionnaires.
|
Caregiver
n=36 participants at risk
Caregivers of Child Participants; caregivers did not receive treatment with crisaborole or vehicle.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Overall Study
|
4.8%
1/21 • Number of events 1 • 3 weeks
|
0.00%
0/15 • 3 weeks
|
0.00%
0/36 • 3 weeks
|
Additional Information
Kevin Thomas, PhD, MBA
Boston University School of Medicine
Phone: 617-358-9787
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place