Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT06021418
Status:
UNKNOWN
Last Update Posted:
2023-09-13
First Post:
2023-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of DKB-119 in Patients in Crow's Feet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '1. Blind: Participant, Outcomes Assessor\n2. Un-blind: Investigator(Care Provider)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-10', 'studyFirstSubmitDate': '2023-04-19', 'studyFirstSubmitQcDate': '2023-08-28', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Crow's feet", 'timeFrame': '18 weeks', 'description': 'Difference in improvement rate (percentage)'}], 'secondaryOutcomes': [{'measure': "Crow's feet", 'timeFrame': '8, 10 weeks', 'description': 'Difference in improvement rate (percentage)'}, {'measure': 'LCL(Lateral Canthal Line) Severity', 'timeFrame': '8, 10, 18 weeks', 'description': 'Difference in improvement rate (percentage)'}, {'measure': 'GAIS(Global Aesthetic Improvement Scale)', 'timeFrame': '8, 10, 18 weeks', 'description': 'GAIS 5 point scale (minimum -1 to maximum 3 points, The higher the score, the better the value)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Crow's Feet"]}, 'descriptionModule': {'briefSummary': "To prove the non-inferiority of DKB-119 by evaluating the injecting efficacy and safety DKB-119 and control for patients in crow's feet", 'detailedDescription': 'A single center, randomized, subject and evaluator blinded, split-face, pivotal clinical trial'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Those who are over 19 under 70 ages.\n* Those who score 2 or more in the LCL severity evaluation.\n* Those who have visually symmetrical crow's feet on both sides.\n* Etc.\n\nExclusion Criteria:\n\n* Pregnancy and lactating women.\n* Etc."}, 'identificationModule': {'nctId': 'NCT06021418', 'briefTitle': "Efficacy and Safety of DKB-119 in Patients in Crow's Feet", 'organization': {'class': 'INDUSTRY', 'fullName': 'Dongkook Pharmaceutical Co., Ltd.'}, 'officialTitle': "A Single Center, Randomized, Subject and Evaluator Blinded, Split-face, Pivotal Clinical Trial to Evaluate the Efficacy and Safety of DKB-119 in Crow's Feet", 'orgStudyIdInfo': {'id': 'DKB-119-MD-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DKB-119', 'description': "Injecting to one side crow's feet", 'interventionNames': ['Device: DKB-119']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': "Injecting to one side crow's feet", 'interventionNames': ['Device: DKB-119']}], 'interventions': [{'name': 'DKB-119', 'type': 'DEVICE', 'description': "Experimental and Acitve Comparator are applied 4 times to each of crow's feet on both sides of the subject.", 'armGroupLabels': ['Control', 'DKB-119']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Chungang-University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dongkook Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}