Wearable Skin Sensors to Assess Nocturnal Scratch Behavior | NCT03770858

Studies
Wearable Skin Sensors to Assess Nocturnal Scratch Behavior

NCT03770858

Sponsor

Northwestern University

Status

Completed

Last Update Posted

Oct 13, 2023Actual

Enrollment

23Actual

Phase

Not provided

Conditions

Atopic Dermatitis

Interventions

Crisaborole
Scratch sensor

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 18, 2019Actual

Primary Completion Date

Aug 30, 2021Actual

Completion Date

Aug 24, 2022Actual

First Submitted Date

Sep 6, 2018

First Submission Date that Met QC Criteria

Dec 7, 2018

First Posted Date

Dec 10, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2023

Last Update Posted Date

Oct 13, 2023Actual

Name	Class
Pfizer	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Pilot study of flexible and wearable sensor to monitor nocturnal scratching behavior

Detailed Description

Present an advanced flexible, and wearable sensor intimately coupled to the skin that can measure the full spectrum of relevant physiological parameters associated with atopic dermatitis including scratch count, scratch duration, scratch intensity, heart rate, heart rate variability and respiratory rate.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Crisaborole and wearable sensor		Subjects will apply topical crisaborole twice daily to the affected atopic dermatitis areas for three weeks.	Drug: Crisaborole Device: Scratch sensor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Crisaborole	Drug	Subject to apply topical crisaborole twice daily to the affected atopic dermatitis areas	Crisaborole and wearable sensor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent agreement of scratching between the experimental sensor and the infrared camera		3 weeks

Secondary Outcomes

Measure	Description	Time Frame
Improvement of sleep parameters (time asleep) measured by the experimental sensor during treatment	Baseline compared to treatment time points will be compared in units of time (minutes/hours)	3 weeks
Improvement of sleep parameters (time until onset of sleep) measured by the experimental sensor

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants with mild to moderate atopic dermatitis ages 2 years or older. This will be determined by clinical diagnosis of AD according to the Hanifin and Rajka criteria with a baseline Investigators Global Assessment score of mild (2) or moderate (3)
Systemic therapy use (e.g. oral corticosteroid, cyclosporine, methotrexate, phototherapy) within 28 days of subject enrollment
Topical corticosteroid use or topical calcineurin inhibitor use within 14 days of subject enrollment
Willingness and ability to set up an infrared video camera nightly
Willing to apply topical crisaborole twice daily to affected atopic dermatitis areas of the body

Exclusion Criteria:

Active skin or systemic infection
Inability to operate a smartphone or video camera
Active atopic dermatitis on he dorsum of the hand or suprasternal notch

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Participants with mild to moderate atopic dermatitis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shuai Xu	Northwestern University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northwestern University		Chicago	Illinois	60611	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003876	Dermatitis, Atopic

Ancestor Terms

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C543085	crisaborole

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided