Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-01-24 @ 9:52 PM
Study NCT ID:
NCT02377557
Status:
COMPLETED
Last Update Posted:
2016-08-17
First Post:
2015-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study to Assess Safety and Utility Pattern of Topical Steroids
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012871', 'term': 'Skin Diseases'}], 'ancestors': [{'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013256', 'term': 'Steroids'}], 'ancestors': [{'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1175}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-15', 'studyFirstSubmitDate': '2015-02-25', 'studyFirstSubmitQcDate': '2015-03-02', 'lastUpdatePostDateStruct': {'date': '2016-08-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of adverse drug reaction upon use of topical steroid', 'timeFrame': '4 week after time of enrollment'}], 'secondaryOutcomes': [{'measure': 'Rate of adverse drug reaction upon use of topical steroid', 'timeFrame': '2 month after time of enrollment'}, {'measure': 'Rate of adverse drug reaction upon use of topical steroid', 'timeFrame': '6 month after time of enrollment'}, {'measure': 'Rate of adverse drug reaction by potency, route of purchase (prescription/self diagnosed), drug classification (prescription only/over the counter)', 'timeFrame': '1 month after time of enrollment'}, {'measure': 'Rate of misuse and overuse of topical steroids', 'timeFrame': '6 month after time of enrollment'}, {'measure': 'Impact of covariates on incidence of adverse drug reaction', 'timeFrame': '6 month after time of enrollment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dermatologic Agent'], 'conditions': ['Skin Diseases']}, 'descriptionModule': {'briefSummary': 'To assess incidence of adverse drug reactions and use pattern of topical steroids among patients who are prescribed or purchase over the counter (OTC) topical steroids for skin conditions in Korea', 'detailedDescription': '* Active collection of safety data, systemic and local adverse events.\n* In addition to spontaneous adverse event reports, patients will be asked on occurrence of adverse events upon use of topical steroids at 1 month, 2 month, and 6 month after study enrollment by e-mail or phone call\n* Causality of adverse events will be assessed by independent two professionals\n* Document the utility pattern of topical steroid, misuse (inappropriate indication) or overuse (in terms of application frequency or treatment duration)\n* Collection of information related with adverse event management'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients or guardian of child purchased topical steroids in Korea', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients or guardian of child purchased topical steroids in Korea\n* Informed consent to participate\n* Willing to follow and abide by the protocol\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02377557', 'briefTitle': 'Observational Study to Assess Safety and Utility Pattern of Topical Steroids', 'organization': {'class': 'OTHER', 'fullName': 'Hanyang University'}, 'officialTitle': 'Topical Steroid Registry: Observational Study to Assess Safety and Use Pattern in Korea', 'orgStudyIdInfo': {'id': 'MFDS2014-20384'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Topical Steroids', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '426-791', 'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'College of Pharmacy, Hanyang University', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}], 'overallOfficials': [{'name': 'Ju-Yeun Lee, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'College of Pharmacy, Hanyang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanyang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Korean Ministry of Food and Drug Safety', 'class': 'UNKNOWN'}, {'name': 'College of Pharmacy, Seoul National University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph.D', 'investigatorFullName': 'Ju-Yeun Lee', 'investigatorAffiliation': 'Hanyang University'}}}}