Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 6:01 AM
Study NCT ID:
NCT04060160
Status:
TERMINATED
Last Update Posted:
2025-01-15
First Post:
2019-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acne Detection Software (AcneDect)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}], 'ancestors': [{'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000071066', 'term': 'Patient Reported Outcome Measures'}], 'ancestors': [{'id': 'D019538', 'term': 'Health Care Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D006302', 'term': 'Health Services Research'}, {'id': 'D006285', 'term': 'Health Planning'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D063868', 'term': 'Patient Outcome Assessment'}, {'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'After careful consideration and review of the data, the study team has determined that it is in the best interest of all parties involved to conclude the study at this juncture.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-13', 'studyFirstSubmitDate': '2019-08-15', 'studyFirstSubmitQcDate': '2019-08-15', 'lastUpdatePostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pictures to train the AcneDect software', 'timeFrame': 'every single day from baseline for 3 months', 'description': 'Collection of pictures to train the AcneDect software to detect change in acne lesions'}], 'secondaryOutcomes': [{'measure': 'AcneDect questionnaire regarding acne burden (Visual Analogue Scale (VAS) scale ranging from "Not bad at all" to "Very bad")', 'timeFrame': 'every single day from baseline for 3 months', 'description': 'Collection of patient reported outcomes via a mobile electronic case report form'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['machine learning', 'self-learning software', 'image-detecting software'], 'conditions': ['Acne Lesions', 'Acne Vulgaris']}, 'descriptionModule': {'briefSummary': "This study is to create a self-learning software that can detect acne lesions. Patients take a picture of their face every single day for 3 months with a secure mobile phone and fill out a pre-designed questionnaire. After 3 months, the mobile will be collected back and the pictures will be evaluated by 3 dermatologists. The software is able to learn from the dermatologists' evaluation and -using machine learning- a mechanism that should be able to automatically detect acne to some extent will be established."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '10 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients within the consultation service of Dermatologische Klinik, Universitätsspital Basel, that meet the inclusion criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acne vulgaris\n\nExclusion Criteria:\n\n* Refusal to participate'}, 'identificationModule': {'nctId': 'NCT04060160', 'acronym': 'AcneDect', 'briefTitle': 'Acne Detection Software (AcneDect)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Acne Detection Software (AcneDect); AcneDect: a Software to Detect Acne Lesions', 'orgStudyIdInfo': {'id': '2018-00702; sp19Navarini'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Self- learning software that can detect acne lesions', 'type': 'OTHER', 'description': 'Self- learning software that can detect acne lesions from patients who take a picture of their face every single day for 3 months with a secure mobile phone.'}, {'name': 'Patient reported outcomes', 'type': 'OTHER', 'description': 'Collection of patient reported outcomes and clinical data via a mobile electronic case report form'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Department of Dermatology, University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Alexander A. Navarini, Prof. Dr. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dermatologische Klinik; Universitätshospital Basel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}