Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-26 @ 1:40 AM
Study NCT ID:
NCT05838833
Status:
UNKNOWN
Last Update Posted:
2023-05-03
First Post:
2023-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ointment to Prevent Scar After Thyroidectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-02-26', 'releaseDate': '2025-02-07'}, {'resetDate': '2025-03-28', 'releaseDate': '2025-03-12'}, {'resetDate': '2025-04-18', 'releaseDate': '2025-04-02'}], 'estimatedResultsFirstSubmitDate': '2025-02-07'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002921', 'term': 'Cicatrix'}], 'ancestors': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-19', 'studyFirstSubmitDate': '2023-03-29', 'studyFirstSubmitQcDate': '2023-04-19', 'lastUpdatePostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Observer overall opinion of POSAS', 'timeFrame': '12 weeks', 'description': 'POSAS POSAS: Patient Observer Scar Assessment Scale'}], 'secondaryOutcomes': [{'measure': 'Observer overall opinion of POSAS', 'timeFrame': '3, 6 weeks', 'description': 'POSAS: Patient Observer Scar Assessment Scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Scar']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to evaluate the efficacy and Safety of INV-001 administration for the prevention of scar after thyroidectomy.\n\nParticipants will be asked to apply ointment on their scar for 12 weeks.', 'detailedDescription': 'to evaluate the efficacy\n\n-investigator check POSAS and VSS'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient who got thyroidectomy due to Thyroid cancer\n* has scar longer than 3 cm\n\nExclusion Criteria:\n\n* have history about Keloid or Hypertrophic scar\n* have infection on surgical site'}, 'identificationModule': {'nctId': 'NCT05838833', 'briefTitle': 'Ointment to Prevent Scar After Thyroidectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Innovo Therapeutics, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of INV-001 Administration for the Prevention of Scar After Thyroidectomy', 'orgStudyIdInfo': {'id': 'INV001-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low dose', 'description': 'low dose ointment', 'interventionNames': ['Drug: INV-001']}, {'type': 'EXPERIMENTAL', 'label': 'High dose', 'description': 'high dose ointment', 'interventionNames': ['Drug: INV-001']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'same ingredient with active drug except API', 'interventionNames': ['Drug: INV-001']}], 'interventions': [{'name': 'INV-001', 'type': 'DRUG', 'description': 'Patient will be assigned to one of three arms.', 'armGroupLabels': ['High dose', 'Low dose', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Minjeong Kim, Master', 'role': 'CONTACT', 'email': 'mjkim@innovothera.com', 'phone': '+82-2-6956-8680'}], 'facility': 'Innovo Therapeutics, Inc.', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Minjeong Kim, Master', 'role': 'CONTACT', 'email': 'mjkim@innovothera.com', 'phone': '82-2-6956-8680'}], 'overallOfficials': [{'name': 'Minjeong Kim, Master', 'role': 'STUDY_DIRECTOR', 'affiliation': 'New Drug development Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Innovo Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-02-07', 'type': 'RELEASE'}, {'date': '2025-02-26', 'type': 'RESET'}, {'date': '2025-03-12', 'type': 'RELEASE'}, {'date': '2025-03-28', 'type': 'RESET'}, {'date': '2025-04-02', 'type': 'RELEASE'}, {'date': '2025-04-18', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Innovo Therapeutics, Inc.'}}}}