Ignite Creation Date:
2024-05-06 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 2:22 PM
Study NCT ID:
NCT05200403
Status:
TERMINATED
Last Update Posted:
2024-03-29
First Post:
2022-01-07
Brief Title:
Improvement In Scratch Behavior And Sleep In Patients With Atopic Dermatitis
Sponsor:
Boston University
Organization:
Boston University
Study Overview
Official Title:
Quantification of Improvement In Scratch Behavior And Sleep In Patients With Atopic Dermatitis on Crisaborole Ointment 2
Status:
TERMINATED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding was stoppped by grantor
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAD
Brief 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
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
Detailed Description:
Approximately 270 children participants age 3 months to 11 years and their primary caregiver participants for a total of 540 participants 270 pairs will be randomized in 11 ratio to either Crisaborole 2 BID or vehicle treatment and will be followed for 2 weeks Participants will be asked to apply a thin even-layer of Crisaborole 2 or vehicle twice daily BID excluding mouth eyes and vagina per label to all locations with active lesions except for handsfingers or within 1 to 2 fingers of the mouth to avoid inadvertent ingestion of ointment and record location and time of application on the daily dosing form provided by study staff and as identified on the Dosing Record Sheet breastfeeding women will be instructed to use the provided gloves when applying Crisaborolevehicle The study will be comprised of an initial screeningbaseline visit for children participants who have an existing diagnosis of symptomatic AD screened and enrolled in the study along with their primary caregivers after signing an informed consent for parentsguardians and assent when appropriate
Primary Objective
1 Evaluate the effects of Crisaborole on itch and night-time scratch as measured by accelerometryactigraphy and Observer Reported Itch Assessment 3 months to 11 years old in children with mild to moderate AD between the ages of 3 months to 11 years old
Secondary Objectives
1 Evaluate the effects of Crisaborole on sleep in children ages 3 months to 11 years with mild to moderate AD
2 Evaluate sleep in primary caregivers
3 Evaluate the QoL measures in response to Crisaborole treatment children 3 months to 11 years
4 Evaluate QoL measures in response to the childs treatment to the parentscaregiversfamilies
5 Evaluate the effect of crisaborole treatment on AD signs symptoms and severity in children ages 3 months to 11 years with mild to moderate AD
The study will consist of a screeningbaseline in-laboratory visit on Day -7 V01 an in-laboratory visit Day 1 V02 an in-laboratory visit on Day 2 V03 for tape-striping and Day 8 V04 for a clinical assessment of the severity of the AD and a final in-laboratory visit on Day 15 V05 for an assessment of the AD tape-stripping completion of ObsROs and return devices Throughout the study the participants and caregivers will wear accelerometry devices continuously optional for those who have active AD on location of device placement with a minimum of at least one wrist device needed for enrollment devices may be removed for short periods of time for such things as the purposes of bathing etc Enrolled participants will be randomly assigned to each arm of the study Participants may come in for an unscheduled visit as needed ie to replace compound etc All in-person study activities including informed consent and pregnancy testing will be completed at the Laboratory for Human Neurobiology 650 Albany St X140 Boston MA 02118 All activities performed in the laboratory are accomplished in private rooms Primary caregivers will be provided with ample time and a privacy curtain to change into a gown during assessment for exclusion of Atopic Dermatitis and primary caregivers will accompany children during all activities to ensure participant privacy All at-home study activities will be completed in the participants home
Primary Objective
1 Evaluate the effects of Crisaborole on itch and night-time scratch as measured by accelerometryactigraphy and Observer Reported Itch Assessment 3 months to 11 years old in children with mild to moderate AD between the ages of 3 months to 11 years old
Secondary Objectives
1 Evaluate the effects of Crisaborole on sleep in children ages 3 months to 11 years with mild to moderate AD
2 Evaluate sleep in primary caregivers
3 Evaluate the QoL measures in response to Crisaborole treatment children 3 months to 11 years
4 Evaluate QoL measures in response to the childs treatment to the parentscaregiversfamilies
5 Evaluate the effect of crisaborole treatment on AD signs symptoms and severity in children ages 3 months to 11 years with mild to moderate AD
The study will consist of a screeningbaseline in-laboratory visit on Day -7 V01 an in-laboratory visit Day 1 V02 an in-laboratory visit on Day 2 V03 for tape-striping and Day 8 V04 for a clinical assessment of the severity of the AD and a final in-laboratory visit on Day 15 V05 for an assessment of the AD tape-stripping completion of ObsROs and return devices Throughout the study the participants and caregivers will wear accelerometry devices continuously optional for those who have active AD on location of device placement with a minimum of at least one wrist device needed for enrollment devices may be removed for short periods of time for such things as the purposes of bathing etc Enrolled participants will be randomly assigned to each arm of the study Participants may come in for an unscheduled visit as needed ie to replace compound etc All in-person study activities including informed consent and pregnancy testing will be completed at the Laboratory for Human Neurobiology 650 Albany St X140 Boston MA 02118 All activities performed in the laboratory are accomplished in private rooms Primary caregivers will be provided with ample time and a privacy curtain to change into a gown during assessment for exclusion of Atopic Dermatitis and primary caregivers will accompany children during all activities to ensure participant privacy All at-home study activities will be completed in the participants home
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| H-42240 | OTHER_GRANT | Pfizer | None |