Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-01-02 @ 6:35 AM
Study NCT ID:
NCT04593004
Status:
COMPLETED
Last Update Posted:
2024-12-06
First Post:
2020-10-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Teledermatology vs. Face-to-Face Visits in the Follow-Up of Patients With Acne
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1:1 stratified random allocation'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2020-10-09', 'studyFirstSubmitQcDate': '2020-10-16', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total time spent by dermatologist after baseline', 'timeFrame': '4 months', 'description': 'Total cumulative time spent by dermatologist for face-to-face consultations or online assessments after baseline.'}], 'secondaryOutcomes': [{'measure': 'Total time spent by patient after baseline', 'timeFrame': '4 months', 'description': 'Total cumulative time spent by patient for visit-related travels and/or online procedures after baseline.'}, {'measure': 'Acne severity improvement', 'timeFrame': '2, 4 and 6 months', 'description': "Acne severity improvement from baseline as assessed by 5-point ordinal investigator's global assessment (IGA) scale, ranging from 1 to 5, with higher scores indicating a worse outcome."}, {'measure': 'Number of therapies prescribed for acne', 'timeFrame': '2, 4 and 6 months'}, {'measure': 'Patient study satisfaction', 'timeFrame': '6 months', 'description': 'Overall patient satisfaction regarding the service received during the study as assessed by 11-point anchored visual analogue scale (VAS), ranging from 0 to 10, with higher scores indicating a better outcome.'}, {'measure': 'Patient quality of life improvement', 'timeFrame': '6 months', 'description': 'Patient quality of life improvement from baseline as assessed by dermatology life quality index (DLQI), ranging from 0 to 30, with higher scores indicating a worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acne', 'telemedicine', 'teledermatology'], 'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': "Acne vulgaris is a common cutaneous inflammatory condition of sebaceous follicles that can profoundly affect patients' quality of life, especially at a young age. In this context the use of teledermatology can potentially reduce the healthcare costs associated to traditional consultations as well as the costs related to travel and loss of school/working time for the patient, with a clear benefit for the whole community. Since 2016, the Department of Dermatology at Inselspital Hospital in Bern has a portal and a smartphone app for online advice service.\n\nHereby the investigators propose to explicitly investigate the efficacy of this system in reducing healthcare costs as compared to traditional face-to-face consultations, in a cohort of patients with mild-to-moderate acne vulgaris."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '28 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Given written informed consent\n* Mild-to-moderate acne as assessed by IGA scale\n* Willingness and ability to adhere the study protocol\n\nExclusion Criteria:\n\n* Need for systemic therapy for acne with Isotretinoin\n* Inability to use the teledermatology system'}, 'identificationModule': {'nctId': 'NCT04593004', 'briefTitle': 'Teledermatology vs. Face-to-Face Visits in the Follow-Up of Patients With Acne', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Randomized Open-Label Trial Comparing Teledermatology vs. Face-to-Face Consultation in the Follow-Up of Patients With Mild-to-Moderate Acne', 'orgStudyIdInfo': {'id': '2019-00620'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Teledermatology', 'interventionNames': ['Device: Teledermatology']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Face-to-face consultation', 'interventionNames': ['Other: Face-to-face consultation']}], 'interventions': [{'name': 'Teledermatology', 'type': 'DEVICE', 'description': 'Patients will be assessed and followed-up by trained physicians through a store-and-forward system (teledermatology online service - Evita® app), which allows patients to upload pictures of skin areas affected by acne as well as their symptoms or questions related to their disease.', 'armGroupLabels': ['Teledermatology']}, {'name': 'Face-to-face consultation', 'type': 'OTHER', 'description': 'Patients will be assessed and followed-up by trained physicians through regular face-to-face outpatient consultations.', 'armGroupLabels': ['Face-to-face consultation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Department of dermatology, University Hospital Inselspital, Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Robert Hunger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Insel Gruppe AG, University Hospital Bern'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}