Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2026-01-01 @ 7:38 AM
Study NCT ID:
NCT06402058
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Comparing DMSB01 and Rejuran® for Temporary Crow's Feet Lines Improvement
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']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A Randomized, Subject and Evaluator blinded, Matched pairs, Pilot Study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-10', 'studyFirstSubmitDate': '2024-05-02', 'studyFirstSubmitQcDate': '2024-05-02', 'lastUpdatePostDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in CFGS at 4, 8, 12 weeks after the last application of the clinical trial medical device compared to the baseline evaluated by Investigator and independent evaluators', 'timeFrame': '4, 8, 12 weeks', 'description': "The Crow's Feet Grading Scale is a 5-point scale with 0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe and 4 = Extreme. 0 is the best outcome while 4 is the worst outcome. The higher scores mean a worse outcome."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Crow's Feet Lines"]}, 'descriptionModule': {'briefSummary': "The objective of this Pilot Study is to verify the safety and efficacy of DMSB01 in the temporary improvement of Crow's Feet Lines"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Among those who desire improvement in both sides of the crow's feet and have a Crow's Feet Grading Scale (CFGS) score of 2 or higher for both relaxed and maximum smile conditions\n2. Individuals who have consented to abstain from any other dermatological procedures or treatments, including treatments for wrinkle reduction in the facial area, during the duration of this study\n\nExclusion Criteria:\n\n1. Individuals with abnormal findings in visual-related tests (visual acuity test, Confrontational visual fields test, ocular motility test), specifically those with low vision (best-corrected visual acuity of 0.3 or less in the better eye).\n2. Individuals who need to take anticoagulants from 2 weeks before the application of the investigational medical device to 2 weeks after the final application (with the exception of low dosage aspirin 100mg (up to a maximum of 300mg/day))\n3. Individuals who need to take Vitamin E preparations, NSAIDs, or collagen preparations from 1 week before the application of the investigational medical device to 1 week after the final application.\n4. History of bleeding disorder in past or present"}, 'identificationModule': {'nctId': 'NCT06402058', 'briefTitle': "A Study Comparing DMSB01 and Rejuran® for Temporary Crow's Feet Lines Improvement", 'organization': {'class': 'INDUSTRY', 'fullName': 'Samyang Biopharmaceuticals Corporation'}, 'officialTitle': "A Randomized, Subject and Evaluator Blinded, Matched Pairs, Pilot Study to Evaluate the Safety and Efficacy of DMSB01 According to the Number of Injections in Subjects With Crow's Feet Lines Compared to Control Device", 'orgStudyIdInfo': {'id': 'DMSB01_CF_301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DMSB01', 'description': 'mPEG-PLA', 'interventionNames': ['Device: DMSB01']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rejuran®', 'description': 'PN', 'interventionNames': ['Device: Rejuran®']}], 'interventions': [{'name': 'DMSB01', 'type': 'DEVICE', 'description': "Apply a maximum of 1.0 ml for each side of the Crow's Feet Lines using both the test device (DMSB01) and the control device (Rejuran®).", 'armGroupLabels': ['DMSB01']}, {'name': 'Rejuran®', 'type': 'DEVICE', 'description': "Apply a maximum of 1.0 ml for each side of the Crow's Feet Lines using both the test device (DMSB01) and the control device (Rejuran®).", 'armGroupLabels': ['Rejuran®']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Gyeongsoon Kim', 'role': 'CONTACT', 'email': 'gyeongsoon.kim@samyang.com', 'phone': '+82-2-2157-9851'}], 'overallOfficials': [{'name': 'Jongho Kim, M.D.,Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samyang Biopharmaceuticals Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}