Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2025-12-28 @ 12:10 PM
Study NCT ID:
NCT00797459
Status:
COMPLETED
Last Update Posted:
2013-09-06
First Post:
2008-11-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety & Tolerability Study That Compares Restylane to Restylane With Lidocaine While Correcting Wrinkles in the Nasolabial Folds
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rstaugaard@medicis.com', 'phone': '480-291-5652', 'title': 'Ron Staugaard', 'organization': 'Medicis'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Restylane-L Side of Face', 'description': 'Restylane with Lidocaine gel(Restylane-L) side of the face. Injection occurs on Day 1 only. Injection amount is determined by achieving the optimal cosmetic results (variable).', 'otherNumAtRisk': 60, 'otherNumAffected': 46, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Restylane Side of Face', 'description': 'The Restylane gel side of the face. Injection occurs on Day 1 only. Injection amount is determined by achieving the optimal cosmetic results (variable).', 'otherNumAtRisk': 60, 'otherNumAffected': 46, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Vascular disorders'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'General disorders'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 27, 'numAffected': 27}], 'organSystem': 'General disorders'}, {'term': 'Tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 26, 'numAffected': 26}], 'organSystem': 'General disorders'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'General disorders'}, {'term': 'Pruitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders'}, {'term': 'Papule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Vasospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Treatment Difference in Pain as Measured by a Visual Analogue Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'units': 'Scores on a Scale', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Restylane', 'description': 'Split-face design with each subject receiving Restylane on one side of the face and Restylane with Lidocaine (Restylane-L) on the other. Injection frequency is once on day 1.'}, {'id': 'OG001', 'title': 'Restylane-L', 'description': 'Split-face design with each subject receiving Restylane on one side of the face and Restylane with Lidocaine (Restylane-L) on the other. Injection frequency is once on day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.9', 'spread': '31.5', 'groupId': 'OG000'}, {'value': '14.7', 'spread': '17.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After Injection on Day of Treatment', 'description': 'No pain is noted at 0 mm and worst pain is noted at 100 mm.', 'unitOfMeasure': 'Scores on a VAS Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Scores on a Scale', 'denomUnitsSelected': 'Participants', 'populationDescription': "This is a split-face design. Restylane and Restylane with Lidocaine was injected to different sides of the subject's face. A total of 60 subjects received both products. The study evaluated which side of the face had less pain, as measured by the Visual Analogue Scale (VAS)."}, {'type': 'SECONDARY', 'title': 'Wrinkle Improvement at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Restylane-L Side of Face', 'description': 'Restylane with Lidocaine gel(Restylane-L) side of the face. Injection occurs on Day 1 only. Injection amount is determined by achieving the optimal cosmetic results (variable).'}, {'id': 'OG001', 'title': 'Restylane Side of Face', 'description': 'The Restylane gel side of the face. Injection occurs on Day 1 only. Injection amount is determined by achieving the optimal cosmetic results (variable).'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '14 days after treatment when compared to baseline', 'description': 'This measure was performed by the validated GAIS tool (Global Asthetic Improvement Scale). The GAIS was completed by the participant at day 14. The GAIS is a qualitative 5 point scale evaluating Aesthetic Improvement (0=worse, 1=no change, 2=Improved, 3=Much Improved, 4=very much improved). Treatment success is defined as at least a one grade improvement (2, 3, or 4) from pre-treatment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Restylane', 'description': 'Split-face design with each subject receiving Restylane on one side of the face and Restylane with Lidocaine (Restylane-L) on the other. Injection frequency is once on day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Restylane', 'description': 'Split-face design with each subject receiving Restylane on one side of the face and Restylane with Lidocaine (Restylane-L) on the other. Injection frequency is once on day 1.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '60', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.1', 'spread': '6.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-20', 'studyFirstSubmitDate': '2008-11-24', 'resultsFirstSubmitDate': '2010-08-11', 'studyFirstSubmitQcDate': '2008-11-24', 'lastUpdatePostDateStruct': {'date': '2013-09-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-01-24', 'studyFirstPostDateStruct': {'date': '2008-11-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-02-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Difference in Pain as Measured by a Visual Analogue Scale', 'timeFrame': 'After Injection on Day of Treatment', 'description': 'No pain is noted at 0 mm and worst pain is noted at 100 mm.'}], 'secondaryOutcomes': [{'measure': 'Wrinkle Improvement at Day 14', 'timeFrame': '14 days after treatment when compared to baseline', 'description': 'This measure was performed by the validated GAIS tool (Global Asthetic Improvement Scale). The GAIS was completed by the participant at day 14. The GAIS is a qualitative 5 point scale evaluating Aesthetic Improvement (0=worse, 1=no change, 2=Improved, 3=Much Improved, 4=very much improved). Treatment success is defined as at least a one grade improvement (2, 3, or 4) from pre-treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Correction of Nasolabial Folds'], 'conditions': ['Nasolabial Folds']}, 'descriptionModule': {'briefSummary': 'Safety \\& tolerability study that compares Restylane to Restylane with Lidocaine (Restylane-L) while correcting wrinkles in the area around your nose.', 'detailedDescription': 'A Randomized, Double-Blind Study Comparing Safety and Tolerability of Restylane® With and Without Addition of 0.3% Lidocaine HCL During Correction of Nasolabial Folds'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects seeking augmentation therapy for correction of bilateral NLFs\n* Same WSRS score at both NLFs (either both Moderate \\[3\\] or both Severe \\[4\\])\n* Subjects willing to give written informed consent to participate in the study\n* Women of childbearing potential willing to use an acceptable form of birth control during the study period\n\nExclusion Criteria:\n\n* Active or chronic skin disease, inflammation or related conditions, near or on the NLFs\n* Subjects who had undergone procedures based on active dermal response e.g., laser or chemical peeling procedures) within 6 months prior to study entry\n* Use of any facial tissue augmenting therapy with non-permanent filler or aesthetic facial surgical therapy within 9 months prior to study entry\n* Permanent implant placed in the NLF area'}, 'identificationModule': {'nctId': 'NCT00797459', 'briefTitle': 'Safety & Tolerability Study That Compares Restylane to Restylane With Lidocaine While Correcting Wrinkles in the Nasolabial Folds', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medicis Global Service Corporation'}, 'officialTitle': 'A Randomized, Double-Blind Study Comparing Safety and Tolerability of Restylane® With and Without Addition of 0.3% Lidocaine HCL During Correction of Nasolabial Folds', 'orgStudyIdInfo': {'id': 'MA-1100-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Restylane and Restylane with Lidocaine', 'description': 'This is a split-face design injecting both Restylane and Restylane-L injectable gels, administered once. Each subject received Restylane on one side of the face, and Restylane-L on the other. Subjects were blinded to which side of their face received Restylane or Restylane-L. The study was randomized and treatments successive.', 'interventionNames': ['Device: Restylane and Restylane-L']}], 'interventions': [{'name': 'Restylane and Restylane-L', 'type': 'DEVICE', 'description': 'This is a split face design and each subject received both Restylane and Restylane-L. Treatments were double blind, randomized, and successive.', 'armGroupLabels': ['Restylane and Restylane with Lidocaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Dermatology Research Institute LLC', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '21030', 'city': 'Hunt Valley', 'state': 'Maryland', 'country': 'United States', 'facility': 'Maryland Laser Skin and Vein Institute', 'geoPoint': {'lat': 39.49983, 'lon': -76.64108}}, {'zip': '10549', 'city': 'Mount Kisco', 'state': 'New York', 'country': 'United States', 'facility': 'The Center for Dermatology, Cosmetic and Laser Surgery', 'geoPoint': {'lat': 41.20426, 'lon': -73.72708}}], 'overallOfficials': [{'name': 'David Bank, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Center for Dermatology, Cosmetic and Laser Surgery'}, {'name': 'Fredric Brandt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dermatology Research Institute LLC'}, {'name': 'Robert Weiss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maryland Laser Skin and Vein Institute'}, {'name': 'Ron Staugaard', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medicis Pharmaceutical'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medicis Global Service Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Q-Med Scandinavia, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}