Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2026-02-25 @ 3:36 AM
Study NCT ID:
NCT02179606
Status:
COMPLETED
Last Update Posted:
2014-07-08
First Post:
2014-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study to Evaluate the Efficacy and Safety of Dermalax Implant Plus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'lastUpdateSubmitDate': '2014-07-04', 'studyFirstSubmitDate': '2014-06-30', 'studyFirstSubmitQcDate': '2014-06-30', 'lastUpdatePostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safty evaluation', 'timeFrame': 'for 24weeks', 'description': 'adverse events, laboratory test, physical examination'}], 'primaryOutcomes': [{'measure': 'Improvement of wrinkle severity system scale(WSRS) scores of both Dermalax implant plus and Restylane® Sub-Q Group', 'timeFrame': 'baseline, week 12', 'description': 'Improvement of wrinkle severity system scale(WSRS) scores at week 12 compared to baseline by independent evaluator using photos.'}], 'secondaryOutcomes': [{'measure': 'Improvement of wrinkle severity system scale(WSRS) scores of both Dermalax implant plus and Restylane® Sub-Q Group', 'timeFrame': 'baseline, at week 2~24', 'description': 'Improvement of wrinkle severity system scale(WSRS) scores at week2, week8, week 16, week 24 compared to baseline by independent evaluator using photos.'}, {'measure': 'Proportion of subjects whose Global Aesthetic improvement Scale (GAIS) scores improved', 'timeFrame': 'at week 2~24', 'description': 'Proportion of subjects whose Global Aesthetic improvement Scale (GAIS) scores improved at week2, week 8, week 12, week 16, week 24 evaluated by investigator at site'}, {'measure': '100 mm visual analogue scale (VAS) scores evaluation', 'timeFrame': 'week 0', 'description': '100 mm visual analogue scale (VAS) scores at both nasolabial folds evaluated by subjects at application of the devices'}]}, 'conditionsModule': {'conditions': ['Correction of Nasolabial Folds']}, 'descriptionModule': {'briefSummary': 'This study is to verify that Dermalax Implant Plus is not inferior to the reference device, Restylane® Sub-Q, in terms of efficacy and safety in the correction of nasolabial folds'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female subjects no younger than 30 and no more than 75 years of age.\n2. Subjects who scored 3 or 4 on the Wrinkle Severity Rating Scale (WSRS) and want to improve the appearance of their nasolabial folds (the subject does not need to have the same score on both sides.\\*)\n\n \\*The scores need not to be same on both sides, but the two nasolabial folds should have symmetry in the range of 3-4.\n3. Subjects who have symmetric nasolabial folds.\n\nExclusion Criteria:\n\n1. Subjects who received an antithrombotic agent within 2 weeks prior to screening (with the exception of low dose Aspirin less than 300 mg/day)\n2. Subjects who have a history of bleeding disorder.\n3. Subjects who have received calcium hydroxyapatite, CaHA injection in nasolabial area.'}, 'identificationModule': {'nctId': 'NCT02179606', 'briefTitle': 'Clinical Study to Evaluate the Efficacy and Safety of Dermalax Implant Plus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Across Co., Ltd.'}, 'officialTitle': 'A Multi-Center, Randomized, Subject and Evaluator Blind, Split-Face Comparative Medical Device Clinical Study to Evaluate the Efficacy and Safety of Dermalax Implant Plus to Restylane® Sub-Q for Correction of Nasolabial Folds', 'orgStudyIdInfo': {'id': 'AC-13-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dermalax Implant Plus', 'description': 'Subject injected in the nasolabial folds of one side of the face in the initial treatment period.', 'interventionNames': ['Device: Dermalax Implant Plus', 'Device: Restylane Sub-Q']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Restylane Sub-Q', 'description': 'Subject injected in the nasolabial folds of one side of the face in the initial treatment period.', 'interventionNames': ['Device: Dermalax Implant Plus', 'Device: Restylane Sub-Q']}], 'interventions': [{'name': 'Dermalax Implant Plus', 'type': 'DEVICE', 'description': 'Dermalax implant plus injection into one nasolabial fold(NFL) of one side of the face(blinded, split-face study design) in the initial treatment period.', 'armGroupLabels': ['Dermalax Implant Plus', 'Restylane Sub-Q']}, {'name': 'Restylane Sub-Q', 'type': 'DEVICE', 'description': 'Restylane Sub-Q injection into one nasolabial fold(NFL) of one side of the face(blinded, split-face study design) in the initial treatment period.', 'armGroupLabels': ['Dermalax Implant Plus', 'Restylane Sub-Q']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Chung-ang University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Eulji General Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Beom Joon Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chung-Ang University Hosptial, Chung-Ang University College of Medicine'}, {'name': 'Jong Hoon Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eulji General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Across Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}