Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-01-03 @ 1:55 PM
Study NCT ID:
NCT03770858
Status:
COMPLETED
Last Update Posted:
2023-10-13
First Post:
2018-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wearable Skin Sensors to Assess Nocturnal Scratch Behavior
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C543085', 'term': 'crisaborole'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-12', 'studyFirstSubmitDate': '2018-09-06', 'studyFirstSubmitQcDate': '2018-12-07', 'lastUpdatePostDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent agreement of scratching between the experimental sensor and the infrared camera', 'timeFrame': '3 weeks'}], 'secondaryOutcomes': [{'measure': 'Improvement of sleep parameters (time asleep) measured by the experimental sensor during treatment', 'timeFrame': '3 weeks', 'description': 'Baseline compared to treatment time points will be compared in units of time (minutes/hours)'}, {'measure': 'Improvement of sleep parameters (time until onset of sleep) measured by the experimental sensor', 'timeFrame': '3 weeks', 'description': 'Baseline compared to treatment time points will be compared in units of time (minutes/hours)'}, {'measure': 'Improvement of sleep parameters (heart rate) measured by the experimental sensor', 'timeFrame': '3 weeks', 'description': 'Baseline compared to treatment time points will be compared in units of beats/min'}, {'measure': 'Improvement of sleep parameters (respiratory rate) measured by the experimental sensor', 'timeFrame': '3 weeks', 'description': 'Baseline compared to treatment time points will be compared in units of breaths/min.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Wearables', 'Atopic Dermatitis', 'Scratch sensor'], 'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'Pilot study of flexible and wearable sensor to monitor nocturnal scratching behavior', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with mild to moderate atopic dermatitis', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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)\n* Systemic therapy use (e.g. oral corticosteroid, cyclosporine, methotrexate, phototherapy) within 28 days of subject enrollment\n* Topical corticosteroid use or topical calcineurin inhibitor use within 14 days of subject enrollment\n* Willingness and ability to set up an infrared video camera nightly\n* Willing to apply topical crisaborole twice daily to affected atopic dermatitis areas of the body\n\nExclusion Criteria:\n\n* Active skin or systemic infection\n* Inability to operate a smartphone or video camera\n* Active atopic dermatitis on he dorsum of the hand or suprasternal notch'}, 'identificationModule': {'nctId': 'NCT03770858', 'briefTitle': 'Wearable Skin Sensors to Assess Nocturnal Scratch Behavior', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '052018SX'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Crisaborole and wearable sensor', 'description': 'Subjects will apply topical crisaborole twice daily to the affected atopic dermatitis areas for three weeks.', 'interventionNames': ['Drug: Crisaborole', 'Device: Scratch sensor']}], 'interventions': [{'name': 'Crisaborole', 'type': 'DRUG', 'description': 'Subject to apply topical crisaborole twice daily to the affected atopic dermatitis areas', 'armGroupLabels': ['Crisaborole and wearable sensor']}, {'name': 'Scratch sensor', 'type': 'DEVICE', 'description': 'advanced, flexible and wearable skin sensor', 'armGroupLabels': ['Crisaborole and wearable sensor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Shuai Xu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Shuai (Steve) Xu', 'investigatorAffiliation': 'Northwestern University'}}}}