Wearable Skin Sensors to Assess Nocturnal Scratch Behavior
NCT03770858
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Adult Trials: 18+ Years
- 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
- 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
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| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title | Wearable Skin Sensors to Assess Nocturnal Scratch Behavior | ||||||
| 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 | ||||||
| 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. | ||||||
| Study Type | Observational | ||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective | ||||||
| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Not Provided | ||||||
| Sampling Method | Non-Probability Sample | ||||||
| Study Population | Participants with mild to moderate atopic dermatitis | ||||||
| Condition | Atopic Dermatitis | ||||||
| Intervention |
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| Study Groups/Cohorts | Crisaborole and wearable sensor
Subjects will apply topical crisaborole twice daily to the affected atopic dermatitis areas for three weeks. Interventions:
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| Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status | Recruiting | ||||||
| Estimated Enrollment | 15 | ||||||
| Original Estimated Enrollment | Same as current | ||||||
| Estimated Study Completion Date | November 2021 | ||||||
| Estimated Primary Completion Date | September 2021 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 2 Years and older (Child, Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers | Yes | ||||||
| Contacts |
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| Listed Location Countries | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT03770858 | ||||||
| Other Study ID Numbers | 052018SX | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Shuai (Steve) Xu, Northwestern University | ||||||
| Study Sponsor | Northwestern University | ||||||
| Collaborators | Pfizer | ||||||
| Investigators |
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| PRS Account | Northwestern University | ||||||
| Verification Date | May 2021 | ||||||