Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-01 @ 12:47 AM
Study NCT ID:
NCT02905851
Status:
COMPLETED
Last Update Posted:
2018-07-02
First Post:
2016-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Teledermatology and Modulation of Antibiotic Dose in Acne Vulgaris
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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-28', 'studyFirstSubmitDate': '2016-06-09', 'studyFirstSubmitQcDate': '2016-09-13', 'lastUpdatePostDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in acne grading (change in patient grading)', 'timeFrame': 'Assessed at 4, 8, 12 weeks', 'description': 'Change in Patient Grading'}, {'measure': 'Change in acne grading (investigator global assessment)', 'timeFrame': 'Assessed at 4, 8, 12 weeks', 'description': 'Change in Investigator Global Assessment'}, {'measure': 'Change in acne grading (lesion counting)', 'timeFrame': 'Assessed at 4, 8, 12 weeks', 'description': 'Change in Lesion Counting'}, {'measure': 'Change in acne grading using the global acne grading', 'timeFrame': 'Assessed at 4, 8, 12 weeks', 'description': 'Change in Global Acne Grading'}], 'primaryOutcomes': [{'measure': 'Reduced antibiotic use', 'timeFrame': 'Assessed at 4, 8, 12 weeks', 'description': 'The difference in antibiotic exposure in the physician feedback group compared to those not receiving feedback'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'To see if teledermatology can be used to reduce antibiotic burden in patients on doxycycline or minocycline for acne vulgaris', 'detailedDescription': 'The investigators are going to ascertain if antibiotic burden can be reduced with tele dermatology use.\n\nThere are two arms of the study:\n\n1. Feedback group\n2. Non feedback group\n\nAll subjects will be randomised to either group, all subjects will take photos of their face and answer questions at baseline, visit 2 (1 month), visit 3 (2 months), visit 4 (3 months).\n\nThe investigators will then use measurements of acne grading (patient grading, investigator global assessment, lesion counting, global acne grading) to reduce/taper antibiotics in the feedback group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects aged 15 years and older\n* Subjects who have been prescribed doxycycline or minocycline by their physician for acne vulgaris but have not initiated treatment yet.\n\nExclusion Criteria:\n\n* Subjects who have used isotretinoin in the last 6 weeks\n* Those who have used oral antibiotics within the last 4 weeks\n* Those who have been initiated or changed brand of oral contraceptive pill within the last one month.\n* Those subjects who cannot engage with the teledermatology platform\n* Prisoners\n* Adults unable to consent'}, 'identificationModule': {'nctId': 'NCT02905851', 'briefTitle': 'Teledermatology and Modulation of Antibiotic Dose in Acne Vulgaris', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Teledermatology and Modulation of Antibiotic Dose in Acne Vulgaris', 'orgStudyIdInfo': {'id': '869597'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Non Feedback', 'description': 'No feedback given to this group regarding their antibiotic use Subjects take images and answer questions during the study like the feedback group, but in this group no feedback re dosing is given.', 'interventionNames': ['Other: Non Feedback group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Feedback group', 'description': 'Feedback given to this group regarding their antibiotic use after baseline.\n\nIf the subject is in the feedback group, after this visit, a dermatologist will review all images and the survey results and give the patient information about whether they should:\n\n1. Continue current dose\n2. Reduce dose if there is at least a one point improvement in both the investigator acne global assessment AND the patient acne global assessment scores: A dose reduction will be such that the dose is halved from the previous dose. For example if the subject is on minocycline or doxycycline 100 mg twice daily, they will be reduced to minocycline or doxycycline 100 mg daily.\n3. Increase dose if had been previously reduced, dose will not be increased beyond the initial starting dose.', 'interventionNames': ['Other: Feedback group']}], 'interventions': [{'name': 'Feedback group', 'type': 'OTHER', 'description': 'Monitoring ability to use teledermatology to modify antibiotic burden', 'armGroupLabels': ['Feedback group']}, {'name': 'Non Feedback group', 'type': 'OTHER', 'description': 'To use as control to see if antibiotic burden has been reduced in the active feedback group', 'armGroupLabels': ['Non Feedback']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Department of Dermatology, Clinical Trials Unit', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Raja Sivamani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UC Davis'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}