Atopic DermatitisNCT03770858
Wearable Skin Sensors to Assess Nocturnal Scratch Behavior
An observational study of Atopic Dermatitis, run by Northwestern University at 1 site in United States.
Trial summary
Pilot study of flexible and wearable sensor to monitor nocturnal scratching behavior Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Crisaborole and Scratch sensor
- Type of treatment
- Medical device
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2019to 24 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants with mild to moderate atopic dermatitis
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Arm, Prospective Clinical Study Using Novel Wearable Sensors to Assess the Improvement of Nocturnal Scratch Behavior and Sleep Quality in Children With Mild-to-moderate Atopic Dermatitis Treated With Topical Crisaborole
Pilot study of flexible and wearable sensor to monitor nocturnal scratching behavior
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- Crisaborole, Scratch sensor
- Keywords
- Wearables, Atopic Dermatitis, Scratch sensor
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrisaboroleDrug
Subject to apply topical crisaborole twice daily to the affected atopic dermatitis areas
Scratch sensorDevice
advanced, flexible and wearable skin sensor
| Study group | Role | What they receive |
|---|---|---|
| Crisaborole and wearable sensor | Subjects will apply topical crisaborole twice daily to the affected atopic dermatitis areas for three weeks. Receives: Drug: Crisaborole; Device: Scratch sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent agreement of scratching between the experimental sensor and the infrared camera
Measured: 3 weeks
Secondary outcomes (4)
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)
Measured: 3 weeks
Improvement of sleep parameters (time until onset of sleep) measured by the experimental sensor
Baseline compared to treatment time points will be compared in units of time (minutes/hours)
Measured: 3 weeks
Improvement of sleep parameters (heart rate) measured by the experimental sensor
Baseline compared to treatment time points will be compared in units of beats/min
Measured: 3 weeks
Improvement of sleep parameters (respiratory rate) measured by the experimental sensor
Baseline compared to treatment time points will be compared in units of breaths/min.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start18 Apr 2019
- Primary completion30 Aug 2021
- Study completion24 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Shuai (Steve) Xu, Northwestern University
- Investigators
- Shuai Xu, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770858
- Sponsor's protocol ID
- 052018SX
- Status last verified
- Oct 2023
- First submitted
- 6 Sep 2018
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Prospective Clinical Study Using Novel Wearable Sensors to Assess the Improvement of Nocturnal Scratch Behavior and Sleep Quality in Children With Mild-to-moderate Atopic Dermatitis Treated With Topical Crisaborole
- ClinicalTrials.gov ID
- NCT03770858
- Acronym / sponsor ID
- 052018SX
- Conditions
- Atopic Dermatitis
- Keywords
- Wearables, Atopic Dermatitis, Scratch sensor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 18 Apr 2019 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 24 Aug 2022 (actual)
- First posted
- 10 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Crisaborole and wearable sensor | – | Drug: Crisaborole, Device: Scratch sensorSubjects will apply topical crisaborole twice daily to the affected atopic dermatitis areas for three weeks. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with mild to moderate atopic dermatitis
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CrisaboroleSubject to apply topical crisaborole twice daily to the affected atopic dermatitis areas | Drug | Crisaborole and wearable sensor |
| Scratch sensoradvanced, flexible and wearable skin sensor | Device | Crisaborole and wearable sensor |
Primary outcome
Percent agreement of scratching between the experimental sensor and the infrared camera
Time frame: 3 weeks
4 secondary outcomes
Improvement of sleep parameters (time asleep) measured by the experimental sensor during treatment
Time frame: 3 weeks
Improvement of sleep parameters (time until onset of sleep) measured by the experimental sensor
Time frame: 3 weeks
Improvement of sleep parameters (heart rate) measured by the experimental sensor
Time frame: 3 weeks
Improvement of sleep parameters (respiratory rate) measured by the experimental sensor
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shuai Xu principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent agreement of scratching between the experimental sensor and the infrared camera (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023.