Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
Study NCT ID:
NCT05137093
Status:
COMPLETED
Last Update Posted:
2023-03-09
First Post:
2021-11-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Scratching Validation Study
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-08', 'studyFirstSubmitDate': '2021-11-05', 'studyFirstSubmitQcDate': '2021-11-23', 'lastUpdatePostDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and precision of the scratching algorithm with reference to the gold standard.', 'timeFrame': "Through study completion, analyst review following each patient's overnight intervention/session", 'description': 'Assessment of the performance of the scratching algorithm as detected by actigraphy compared to infra red video monitoring.'}], 'secondaryOutcomes': [{'measure': 'Agreement via additional performance metrics between the scratching algorithm and the gold standard.', 'timeFrame': "Through study completion, analyst review following each patient's overnight intervention/session", 'description': "Overall agreement of algorithm-determined scratching events and total duration compared to video scoring of scratching events; Other performance metrics such as Cohen's kappa and correlation between the number and duration of scratching events detected by the scratching algorithm versus video scoring"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Scratching'], 'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'Single center, analyst-blinded, study comparing the scratching events identified via an actigraphy scoring algorithm versus manual scoring of an overnight video recording, undertaken in a sample of 40 adult patients with atopic dermatitis and controls.', 'detailedDescription': 'The Philips scratching algorithm has been cross-validated against the gold-standard assessment of scratching. The algorithm has been used in many drug development trials, occasionally as a means of generating secondary endpoints, but most often as a means of generating exploratory endpoints. The purpose of the proposed study is therefore to validate the data generated by the scratching study compared to the gold-standard video-assessment of scratching, in an independent sample of adults with atopic dermatitis and age- and sex-matched controls'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy \\& Atopic dermatitis subjects', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Be aged 18 to 75 years, inclusive\n* Be willing and able to undergo a single night of actigraphy and video monitoring overnight in a laboratory\n* Be willing and able to provide informed consent\n* (patients only): Diagnosed with atopic dermatitis by a clinician, following the criteria listed in Table 1.\n* (patients only): IGA score ≥ 2.\n* (patients only): Willing and able to use only non-medicated topical therapy (i.e., bland emollient/moisturizer) for 7 days before the overnight visit.\n* Participants should be in bed a minimum of 4 hours\n\nExclusion Criteria:\n\n* Any acute and/or unstable illness or medical complication which, in the opinion of a clinician, could compromise data collection and/or interpretation\n* Use of any over-the-counter, prescription, or recreational drugs that may induce sleep or pruritus within 24 hours prior to overnight monitoring\n* Use of any over-the-counter or prescription treatment (systemic, or topical) that could affect the course of atopic dermatitis during the study period. Key medications are listed below:\n\n * From 3 Months prior to overnight visit: Biological products that might have significantly affected the evaluation of atopic dermatitis condition (e.g., tumor necrosis factor inhibitors, antiimmunoglobulin IgE antibodies, anti-CD20 antibodies, anti-interleukin-4 receptor)\n * Has used systemic treatments that could affect AD within 30 days or 5 half- lives before the overnight visit. (i.e. retinoids, methotrexate, cyclosporine, hydroxycarbamide (hydroxyurea), azathioprine and systemic corticosteroids)\n * Phototherapy treatment, laser therapy, bleach baths, tanning booths or extended sun exposure that could affect disease severity or interfere with disease assessments within 30 days before the overnight visit.\n * Use within 21 days before the overnight visit: Topical corticosteroids that were classified as super-high potency (clobetasol propionate).\n * Use within 14 days before the overnight visit: any other topical phosphodiesterase 4 (PDE4) inhibitor; Tacrolimus and pimecrolimus cream and/or ointment; Topical corticosteroids that were classified as low, medium, or high potency (e.g., fluocinonide, triamcinolone acetonide, desonide, hydrocortisone).\n * From 7 days before the overnight visit:\n\n * antibiotics\n * antifungal or antivirus medications\n * Antihistamines/anti-allergics: diphenhydramine, chlorpheniramine maleate, hydroxyzine)\n * Topical phosphodiesterase 4 (PDE4) inhibitor\n * Topical calcineurin inhibitors (tacrolimus and pimecrolimus cream and/or ointment)\n * Topical corticosteroids that were classified as low, medium, or high potency (e.g., fluocinonide, triamcinolone acetonide, desonide, hydrocortisone)\n * Any other topical therapy with active ingredients to treat AD or with additives that could affect AD (e.g., hyaluronic acid, urea, ceramide or filaggrin degradation products).\n* Individuals clinically diagnosed with a sleep disorder who are NOT on a controlled treatment regime\n* An Epworth Sleepiness Scale score of ≥11, indicating daytime hypersomnolence\n* Previous diagnosis of a movement disorder, including but not limited to, restless legs syndrome, periodic limb movement disorder, Tourette's syndrome, tremor, or dystonia\n* Commercial driver's license and/or high-risk occupation that could be impacted by the occurrence of daytime sleepiness\n* Self-reported habitual sleep duration of \\<6 hours per night on average\n* Shift worker, advanced/delayed circadian phase, and/or any other condition suggesting that the participant would be unable to sleep during overnight monitoring\n* Self-reported pregnancy current or planned during the study\n* Employee or spouse of an employee of company that designs, sells, or manufactures sleep related products and/or wearable devices (including Philips).\n* (patients only): Any significant dermatological condition, other than atopic dermatitis, as determined by a clinician.\n* (controls only): Any significant dermatological condition as determined by a clinician.\n* Currently using medication for any skin disease/condition and could not, in the opinion of the investigator, tolerate restriction or discontinuation of the medication as required by the study."}, 'identificationModule': {'nctId': 'NCT05137093', 'briefTitle': 'Scratching Validation Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philips Clinical & Medical Affairs Global'}, 'officialTitle': 'Independent Validation Study of Nighttime Scratching Quantification With Actigraphy in Adults With Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'SRC_NBS_GENEActiv_2019_10763'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy subjects', 'description': 'Healthy subjects', 'interventionNames': ['Device: Actigraphy Device']}, {'label': 'Atopic dermatitis', 'description': 'Atopic dermatitis', 'interventionNames': ['Device: Actigraphy Device']}], 'interventions': [{'name': 'Actigraphy Device', 'type': 'DEVICE', 'description': 'Patients will wear actigraphy device which detects scratching events.', 'armGroupLabels': ['Atopic dermatitis', 'Healthy subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63143', 'city': 'Maplewood', 'state': 'Missouri', 'country': 'United States', 'facility': 'Clayton Sleep Institute', 'geoPoint': {'lat': 38.61255, 'lon': -90.32456}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philips Clinical & Medical Affairs Global', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}