Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2026-04-15 @ 10:50 PM
Study NCT ID:
NCT01689857
Status:
COMPLETED
Last Update Posted:
2013-04-15
First Post:
2012-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Trial to Evaluate the Safety and Efficacy of Scarclinic™ Thin in Surgical Scars
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lionheo@snu.ac.kr', 'phone': '82317877222', 'title': 'Dr. Chanyeong Heo', 'organization': 'Seoul National University Bundang Hospital'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Scarclinic™ Thin', 'description': 'Scarclinic™ Thin applied on the surgical scar for 12weeks', 'otherNumAtRisk': 20, 'otherNumAffected': 12, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Scarclinic™ Normal', 'description': 'Scarclinic™ Normal applied on the surgical scar for 12weeks', 'otherNumAtRisk': 20, 'otherNumAffected': 9, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'itching sense', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Vancouver Scar Scale Score(VSS) at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Scarclinic™ Thin', 'description': 'Scarclinic™ Thin applied on the surgical scar for 12weeks'}, {'id': 'OG001', 'title': 'Scarclinic™ Normal', 'description': 'Scarclinic™ Normal applied on the surgical scar for 12weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.80', 'spread': '3.02', 'groupId': 'OG000'}, {'value': '-2.61', 'spread': '2.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 months', 'description': 'Scar assessment will be performed at the beginning of the treatment, and at the end of the 3 month when the treatment is completed by using the Vancouver scar scale.VSS assesses 6 variables.\n\n* vascularity(range from normal(0 point) to purple(3point)\n* pigmentation(range from normal(0 point) to hyper-pigmentation(3point)\n* pliability(range from normal(0 point) to contracture(5point)\n* height (range from flat(0 point) to above 5mm(3point)\n* pain(range from none(0 point) to Require medication(2point)\n* itchiness(range from none(0 point) to Require medication(2point)\n\nWe assess total score that are minimum score is 0 and maximum is 18. The lowest score means the best scar condition.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants for whom Vancouver Scar Scale measurements were recorded at Baseline and 3 months.'}, {'type': 'SECONDARY', 'title': 'Satisfaction for Serviceability', 'timeFrame': 'the end of the 3 month of the treatment', 'description': 'Satisfaction for serviceability will be performed at the end of the 3 month when the treatment was completed by using Questionaire', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Scarclinic™ Thin', 'description': 'Scarclinic™ Thin applied on the surgical scar for 12weeks'}, {'id': 'FG001', 'title': 'Scarclinic™ Normal', 'description': 'Scarclinic™ Normal applied on the surgical scar for 12weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'This study was conducted at Seoul National University Bundang hospital. Forty subjects were recruited from May, 2010 to April,2012.', 'preAssignmentDetails': 'In this study, we had no run-in period before study was commenced and there were no subjects who drop out before enrollment and randomization to groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Scarclinic™ Thin', 'description': 'Scarclinic™ Thin applied on the surgical scar for 12weeks'}, {'id': 'BG001', 'title': 'Scarclinic™ Normal', 'description': 'Scarclinic™ Normal applied on the surgical scar for 12weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.90', 'spread': '10.47', 'groupId': 'BG000'}, {'value': '36.00', 'spread': '9.93', 'groupId': 'BG001'}, {'value': '37.95', 'spread': '10.26', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-12', 'studyFirstSubmitDate': '2012-09-13', 'resultsFirstSubmitDate': '2012-12-03', 'studyFirstSubmitQcDate': '2012-09-17', 'lastUpdatePostDateStruct': {'date': '2013-04-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-04-12', 'studyFirstPostDateStruct': {'date': '2012-09-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Vancouver Scar Scale Score(VSS) at 3 Months', 'timeFrame': 'Baseline and 3 months', 'description': 'Scar assessment will be performed at the beginning of the treatment, and at the end of the 3 month when the treatment is completed by using the Vancouver scar scale.VSS assesses 6 variables.\n\n* vascularity(range from normal(0 point) to purple(3point)\n* pigmentation(range from normal(0 point) to hyper-pigmentation(3point)\n* pliability(range from normal(0 point) to contracture(5point)\n* height (range from flat(0 point) to above 5mm(3point)\n* pain(range from none(0 point) to Require medication(2point)\n* itchiness(range from none(0 point) to Require medication(2point)\n\nWe assess total score that are minimum score is 0 and maximum is 18. The lowest score means the best scar condition.'}], 'secondaryOutcomes': [{'measure': 'Satisfaction for Serviceability', 'timeFrame': 'the end of the 3 month of the treatment', 'description': 'Satisfaction for serviceability will be performed at the end of the 3 month when the treatment was completed by using Questionaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hypertropic scar, Vancouver scar scale, silicon gel sheet'], 'conditions': ['Hypertrophic Surgical Scar']}, 'descriptionModule': {'briefSummary': 'Compare the efficacy and safety of Scarclinic™Thin and Scarclinic™ Normal for the treatment of surgical scars.\n\nParticipant: 40 Treatment period : 3 months Medical device: Scarclinic™Thin , Scarclinic™ Normal Randomization: Table of random number', 'detailedDescription': 'For evaluating the efficacy\n\n* The investigator check Vancouver Scar Scale at 1 and 3 month after application to evaluate vascularity, pigmentation, elasticity, height, pain and itchiness\n* The participant filled out survey included questions regarding convenience in use at 1 and 3 month after application.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient who aged more than 18 years and less 55 years\n* Patient who has a surgical scar that is not over 3 months after the surgery\n* Patient who sign informed consent form for the study\n\nExclusion Criteria:\n\n* need wound dressing for exudate\n* wound infection\n* general malaise\n* history of mental disorders\n* taking anticancer drugs or antiphlogistics or steroid'}, 'identificationModule': {'nctId': 'NCT01689857', 'briefTitle': 'Clinical Trial to Evaluate the Safety and Efficacy of Scarclinic™ Thin in Surgical Scars', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Phase 4 Study of Scarclinic™ Thin That Treats Surgical Scars.', 'orgStudyIdInfo': {'id': 'E-1004-048-004'}, 'secondaryIdInfos': [{'id': '06-2010-049', 'type': 'OTHER_GRANT', 'domain': 'ILDONG Pharmaceutical CO. LTD.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Scarclinic™ Thin', 'description': 'Scarclinic™ Thin', 'interventionNames': ['Device: Scarclinic™ Thin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Scarclinic™ Normal', 'description': 'Scarclinic™ Normal', 'interventionNames': ['Device: Scarclinic™ Normal']}], 'interventions': [{'name': 'Scarclinic™ Thin', 'type': 'DEVICE', 'description': 'Apply Scarclinic™ Thin on the scar and dispense 4 ea.for each participant for 3 month.', 'armGroupLabels': ['Scarclinic™ Thin']}, {'name': 'Scarclinic™ Normal', 'type': 'DEVICE', 'description': 'Apply Scarclinic™ Normal on the scar and dispense 4 ea.for each participant for 3 month.', 'armGroupLabels': ['Scarclinic™ Normal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Bundang-gu', 'state': 'Seongnam-si,Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National Univ. Bundang Hospital'}], 'overallOfficials': [{'name': 'ChanYoung Heo, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Chan-Yeong Heo', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}