Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-27 @ 12:18 AM
Study NCT ID:
NCT03174132
Status:
COMPLETED
Last Update Posted:
2022-08-26
First Post:
2017-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pain and Safety of Restylane Perlane With and Without Lidocaine for Correction of Moderate and Severe Nasolabial Folds
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'reception.seupp@galderma.com', 'phone': '+46184749000', 'title': 'Reception', 'organization': 'Galderma'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Maximum 32 days for each participant (from screening visit to last visit).', 'description': 'AEs collection began after the informed consent form had been signed. Each subject was questioned about AEs at each clinical visit following the screening visit. The question asked was "Since your last clinical visit have you had any health problems?" Information on AEs could also be obtained from signs and symptoms detected during each examination or from a laboratory test, observations by the study personnel, subject diaries or spontaneous reports from the subjects.', 'eventGroups': [{'id': 'EG000', 'title': 'Restylane Perlane Lidocaine and Restylane Perlane', 'description': 'Restylane Perlane Lidocaine will be injected into one side of the nasolabial fold at day 1\n\nRestylane Perlane Lidocaine: Intradermal injection\n\nRestylane Perlane will be injected into the opposite side of the nasolabial fold on day 1\n\nRestylane Perlane: Intradermal injection', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 7, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Myofascial pain syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Treatment Differences in Pain (Restylane Perlane Side - Restylane Perlane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Restylane Perlane Lidocaine and Restylane Perlane', 'description': 'Restylane Perlane Lidocaine will be injected into one side of the nasolabial fold at day 1\n\nRestylane Perlane Lidocaine: Intradermal injection\n\nRestylane Perlane will be injected into the opposite side of the nasolabial fold on day 1\n\nRestylane Perlane: Intradermal injection'}], 'classes': [{'categories': [{'measurements': [{'value': '87.1', 'groupId': 'OG000', 'lowerLimit': '77.0', 'upperLimit': '93.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the time of injection', 'description': 'Subjects that reported at least 10 mm less VAS pain associated with injections of Perlane-Lido compared to Perlane at the time of injection.\n\nVAS=Visual Analogue Scale. The VAS is a subjective scale to measure pain intensity. The participant is instructed to put a vertical mark, approximating the pain experienced during the procedure, on a 100 mm (millimeter) horizontal line labelled "no pain" at the left end and "the worst pain you can imagine" at the right end. The distance in mm from the left end (no pain) to the participant\'s VAS mark is measured with a standard ruler.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Treatment Differences in Pain (Restylane Perlane Side - Restylane Perlane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Restylane Perlane Lidocaine and Restylane Perlane', 'description': 'Restylane Perlane Lidocaine will be injected into one side of the nasolabial fold at day 1\n\nRestylane Perlane Lidocaine: Intradermal injection\n\nRestylane Perlane will be injected into the opposite side of the nasolabial fold on day 1\n\nRestylane Perlane: Intradermal injection'}], 'classes': [{'title': 'after 15 minutes', 'categories': [{'measurements': [{'value': '64.3', 'groupId': 'OG000', 'lowerLimit': '51.9', 'upperLimit': '75.4'}]}]}, {'title': 'after 30 minutes', 'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000', 'lowerLimit': '31.1', 'upperLimit': '55.3'}]}]}, {'title': 'after 45 minutes', 'categories': [{'measurements': [{'value': '31.4', 'groupId': 'OG000', 'lowerLimit': '20.9', 'upperLimit': '43.6'}]}]}, {'title': 'after 60 minutes', 'categories': [{'measurements': [{'value': '24.3', 'groupId': 'OG000', 'lowerLimit': '14.8', 'upperLimit': '36'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15, 30, 45, and 60 minutes after injection', 'description': 'Subjects that reported at least 10 mm less VAS pain associated with injections of Perlane-Lido compared to Perlane at 15, 30, 45 and 60 minutes after injection.\n\nVAS=Visual Analogue Scale. The VAS is a subjective scale to measure pain intensity. The participant is instructed to put a vertical mark, approximating the pain experienced during the procedure, on a 100 mm (millimeter) horizontal line labelled "no pain" at the left end and "the worst pain you can imagine" at the right end. The distance in mm from the left end (no pain) to the participant\'s VAS mark is measured with a standard ruler.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Restylane Perlane Lidocaine and Restylane Perlane', 'description': 'Restylane Perlane Lidocaine will be injected into one side of the nasolabial fold at day 1\n\nRestylane Perlane Lidocaine: Intradermal injection\n\nRestylane Perlane will be injected into the opposite side of the nasolabial fold on day 1\n\nRestylane Perlane: Intradermal injection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Restylane Perlane Lidocaine and Restylane Perlane', 'description': 'Restylane Perlane Lidocaine will be injected into one side of the nasolabial fold at day 1\n\nRestylane Perlane Lidocaine: Intradermal injection\n\nRestylane Perlane will be injected into the opposite side of the nasolabial fold on day 1\n\nRestylane Perlane: Intradermal injection'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '64', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.2', 'spread': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '60', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Han Chinese', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Taiwan', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-04-13', 'size': 4638497, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-06-11T04:51', 'hasProtocol': True}, {'date': '2017-09-07', 'size': 924899, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-06-11T04:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-01-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-24', 'studyFirstSubmitDate': '2017-05-29', 'resultsFirstSubmitDate': '2019-06-11', 'studyFirstSubmitQcDate': '2017-06-01', 'lastUpdatePostDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-16', 'studyFirstPostDateStruct': {'date': '2017-06-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Differences in Pain (Restylane Perlane Side - Restylane Perlane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS)', 'timeFrame': 'At the time of injection', 'description': 'Subjects that reported at least 10 mm less VAS pain associated with injections of Perlane-Lido compared to Perlane at the time of injection.\n\nVAS=Visual Analogue Scale. The VAS is a subjective scale to measure pain intensity. The participant is instructed to put a vertical mark, approximating the pain experienced during the procedure, on a 100 mm (millimeter) horizontal line labelled "no pain" at the left end and "the worst pain you can imagine" at the right end. The distance in mm from the left end (no pain) to the participant\'s VAS mark is measured with a standard ruler.'}], 'secondaryOutcomes': [{'measure': 'Treatment Differences in Pain (Restylane Perlane Side - Restylane Perlane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS)', 'timeFrame': '15, 30, 45, and 60 minutes after injection', 'description': 'Subjects that reported at least 10 mm less VAS pain associated with injections of Perlane-Lido compared to Perlane at 15, 30, 45 and 60 minutes after injection.\n\nVAS=Visual Analogue Scale. The VAS is a subjective scale to measure pain intensity. The participant is instructed to put a vertical mark, approximating the pain experienced during the procedure, on a 100 mm (millimeter) horizontal line labelled "no pain" at the left end and "the worst pain you can imagine" at the right end. The distance in mm from the left end (no pain) to the participant\'s VAS mark is measured with a standard ruler.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nasolabial Fold']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the pain and safety in associated with injection of Restylane Perlane Lidocaine compared to Restylane Perlane using VAS scale'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed and dated informed consent to participate in the study.\n* Men or women aged 20 years or older of Chinese origin.\n* Subjects willing to abstain from any other facial plastic surgical or cosmetic procedures below the level of the lower orbital rim for the duration of the study.\n* Intent to undergo correction of both nasolabial folds (NLF) with a wrinkle severity in Wrinkle Severity Rating Scale (WSRS) of either grade 3 on both NLFs or grade 4 on both NLFs.\n\nExclusion Criteria:\n\n* Previous tissue augmentation therapy or contouring with any permanent (non-biodegradable) or semi-permanent filler, autologous fat, lifting threads or permanent implant below the level of the lower orbital rim.\n* Previous use of any hyaluronic acid based or collagen based biodegradable facial tissue augmentation therapy below the level of the lower orbital rim within 12 months before treatment.\n* Previous tissue revitalization treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling or dermabrasion in the midface within 6 months before treatment.\n* Scars or deformities, active skin disease, inflammation or related conditions near or in the area to be treated.\n* Other condition preventing the subject from entering the study in the Investigator's opinion"}, 'identificationModule': {'nctId': 'NCT03174132', 'briefTitle': 'Pain and Safety of Restylane Perlane With and Without Lidocaine for Correction of Moderate and Severe Nasolabial Folds', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'A Randomised, Multi-center, Subject and Evaluator-blinded Study Comparing the Pain and the Safety Profile Associate With Correction of Moderate to Severe Nasolabial Folds Using Restylane Perlane Lidocaine Compared to Restylane Perlane', 'orgStudyIdInfo': {'id': '43TW1628'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Restylane Perlane Lidocaine', 'description': 'Restylane Perlane Lidocaine will be injected into one side of the nasolabial fold at day 1', 'interventionNames': ['Device: Restylane Perlane Lidocaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Restylane Perlane', 'description': 'Restylane Perlane will be injected into the opposite side of the nasolabial fold on day 1', 'interventionNames': ['Device: Restylane Perlane']}], 'interventions': [{'name': 'Restylane Perlane Lidocaine', 'type': 'DEVICE', 'description': 'Intradermal injection', 'armGroupLabels': ['Restylane Perlane Lidocaine']}, {'name': 'Restylane Perlane', 'type': 'DEVICE', 'description': 'Intradermal injection', 'armGroupLabels': ['Restylane Perlane']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Medical University', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Medical University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Q-Med AB', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Galderma R&D'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galderma R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}