Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-02-05 @ 10:57 AM
Study NCT ID:
NCT03170050
Status:
COMPLETED
Last Update Posted:
2021-05-10
First Post:
2017-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of YYD701-2 for Treatment of Nasolabial Folds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The Subjects are injected investigational devide(YYD701-2 or Restylane Perlane Lidocaine) in right or left nasolabial folds'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-11-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-07', 'studyFirstSubmitDate': '2017-03-30', 'studyFirstSubmitQcDate': '2017-05-25', 'lastUpdatePostDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in Wrinkle Severity Rating Scale (WSRS) as evaluated by independent evaluator through Photographs.', 'timeFrame': 'from baseline to 24 weeks', 'description': 'Score of WSRS assessed by the independent evaluator'}], 'secondaryOutcomes': [{'measure': 'The change in Wrinkle Severity Rating Scale (WSRS) as evaluated by independent evaluator through Photographs.', 'timeFrame': 'from baseline to 2, 8, 16 weeks', 'description': 'Score of WSRS assessed by the independent evaluator'}, {'measure': 'The change in Wrinkle Severity Rating Scale (WSRS) as evaluated by investigator.', 'timeFrame': 'from baseline to 2, 8, 16, 24 weeks', 'description': 'Score of WSRS assessed by the investigator'}, {'measure': 'Proportion of subjects with a ≥ 1 point on Global Aesthetic Improvement Scale as evaluated by an investigator', 'timeFrame': '2, 8, 16, 24 weeks after week 0 (injection date)', 'description': 'Score of GAIS assessed by the investigator'}, {'measure': 'Proportion of subjects with a ≥ 1 point on Global Aesthetic Improvement Scale as evaluated by a subject', 'timeFrame': '2, 8, 16, 24 weeks after week 0 (injection date)', 'description': 'Score of GAIS assessed by subject'}, {'measure': 'Proportion of subjects with a ≥ 1 point change on Wrinkle Severity Rating Scale as evaluated by independent evaluator through Photographs.', 'timeFrame': 'from baseline to 2, 8, 16, 24 weeks', 'description': 'Score of WSRS assessed by the independent evaluator'}, {'measure': 'Proportion of subjects with a ≥ 1 point change on Wrinkle Severity Rating Scale as evaluated by the investigator', 'timeFrame': 'from baseline to 2, 8, 16, 24 weeks', 'description': 'Score of WSRS assessed by the investigator'}, {'measure': 'Visual Analogue Scale as evaluated by a subject', 'timeFrame': 'week 0 (injection date)', 'description': 'Score of VAS assessed by subject'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Wrinkle Severity Rating Scale(WSRS) Grade 3 (Moderate) or 4 (Severe) of Nasolabial Folds']}, 'descriptionModule': {'briefSummary': 'A multicenter, active-controlled, randomized, evaluator and subject blinded, split-face, comparative, non-inferiority, Medical device Clinical trial.\n\nThis study is randomized, evaluator and subject blinded, split-face medical device Clinical trial. The Subjects are injected investigational device(YYD701-2 or Restylane Perlane Lidocaine) in right or left nasolabial folds.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and Female aged between 30 and 75 years, inclusive\n* Subjects who want improvement of nasolabial folds that are rated as grade 3 or 4 on Wrinkle severity rating scale(WSRS)\n* Subjects who have visually symmetrical bilateral nasolabial folds\n* Subjects who consent to discontinue all dermatological treatment or cure including wrinkle correction in and around infraorbital region during this trial\n* Subjects who voluntarily decide to participate in this trial and provide written consent in the Informed Consent Form\n\nExclusion Criteria:\n\n* Subject who have bleeding disorder in the past or present\n* Other criteria as identified in the protocol'}, 'identificationModule': {'nctId': 'NCT03170050', 'briefTitle': 'Clinical Trial of YYD701-2 for Treatment of Nasolabial Folds', 'organization': {'class': 'INDUSTRY', 'fullName': 'Yooyoung Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Multicenter, Active-controlled, Randomized, Evaluator and Subject Blinded, Split-face, Comparative, Non-inferiority and Confirmatory Clinical Study of the Efficacy and Safety Between YYD701-2 and Restylane Perlane Lidocaine for Temporary Correction of Moderate to Severe Nasolabial Folds', 'orgStudyIdInfo': {'id': 'YYP-YYD701_001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'YYD701-2', 'description': 'YYD701-2 Hyaluronic Acid Gel and Lidocaine Hydrochlorid, total dose 1ml, single injection', 'interventionNames': ['Device: YYD701-2']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Restylane Perlane Lidocaine', 'description': 'Restylane Perlane Lidocaine Hyaluronic Acid Gel and Lidocaine Hydrochlorid, total dose 1ml, single injection', 'interventionNames': ['Device: Restylane Perlane Lidocaine']}], 'interventions': [{'name': 'YYD701-2', 'type': 'DEVICE', 'description': 'HA Filler', 'armGroupLabels': ['YYD701-2']}, {'name': 'Restylane Perlane Lidocaine', 'type': 'DEVICE', 'description': 'HA Filler', 'armGroupLabels': ['Restylane Perlane Lidocaine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Chung-Ang Univ. Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Konkuk University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yooyoung Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}