Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-02-20 @ 6:52 PM
Study NCT ID:
NCT01720056
Status:
TERMINATED
Last Update Posted:
2015-06-10
First Post:
2012-10-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Verapamil vs Steroid to Prevent Keloid Recurrence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007627', 'term': 'Keloid'}], 'ancestors': [{'id': 'D003095', 'term': 'Collagen Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014700', 'term': 'Verapamil'}, {'id': 'D014221', 'term': 'Triamcinolone'}], 'ancestors': [{'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'whyStopped': 'Objective of study achieved after interim analysis.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-09', 'studyFirstSubmitDate': '2012-10-30', 'studyFirstSubmitQcDate': '2012-10-30', 'lastUpdatePostDateStruct': {'date': '2015-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Keloid recurrence', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Vancouver Scar Scale Score', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Keloid Scars']}, 'descriptionModule': {'briefSummary': 'Keloid scarring is a severe cosmetic and painful disease of the skin. The gold standard treatment is yet to be clarified. This randomized clinical pilot study will compare the effects of two local treatments for preventing keloid recurrence after surgical removal; steroid and verapamil.\n\nStudy hypothesis: Intralesional therapy with the calcium antagonist verapamil has equal treatment efficacy as steroid injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient undergoing surgical removal of keloid\n* Patient 18 years old or greater\n* Length of excisional scar after surgical removal of keloid between 2 and 10 cm\n\nExclusion Criteria:\n\n* Keloid in face or hands\n* Pregnancy or lactation\n* Dementia\n* Any heart or pulmonary condition\n* Systemic treatment with beta-blockers, ACE-inhibitors or calcium antagonists\n* Systemic corticosteroidal therapy\n* Intralesional steroid treatment within 2 months of surgery to remove keloid\n* Flap surgery\n* Lesions to face, hands and other cosmetically sensitive areas'}, 'identificationModule': {'nctId': 'NCT01720056', 'briefTitle': 'Verapamil vs Steroid to Prevent Keloid Recurrence', 'organization': {'class': 'OTHER', 'fullName': 'The University of Western Australia'}, 'officialTitle': 'Assessment of Verapamil as an Adjunct for Prevention of Keloid Recurrence After Surgical Removal', 'orgStudyIdInfo': {'id': 'EC 067/2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Verapamil', 'description': 'Verapamil 2.5 mg/mL injection sc intralesionally', 'interventionNames': ['Drug: Verapamil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Kenalog 10', 'description': 'Kenalog 10 mg/mL injection sc intralesionally', 'interventionNames': ['Drug: Kenalog 10']}], 'interventions': [{'name': 'Verapamil', 'type': 'DRUG', 'armGroupLabels': ['Verapamil']}, {'name': 'Kenalog 10', 'type': 'DRUG', 'armGroupLabels': ['Kenalog 10']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6001', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Royal Perth Hospital', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}], 'overallOfficials': [{'name': 'Fiona M Wood, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Western Australia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Western Australia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Wood', 'investigatorFullName': 'Fiona M. Wood', 'investigatorAffiliation': 'The University of Western Australia'}}}}