Ignite Creation Date:
2025-12-24 @ 11:06 PM
Ignite Modification Date:
2025-12-25 @ 8:38 PM
Study NCT ID:
NCT00823069
Status:
COMPLETED
Last Update Posted:
2010-11-30
First Post:
2009-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety Study That Compares Perlane to Perlane With Lidocaine (Perlane-L) While Correcting Wrinkles in the Area Around Your Nose
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'msanstead@medicis.com', 'phone': '480-291-5926', 'title': 'Mary Sanstead', 'organization': 'Medicis'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Perlane-L', 'description': 'Split face design with each subject receiving Perlane on one side of the face and Perlane-L on the other. After treatments the patient scores pain experienced on a 2 VAS scales. One VAS represents pain on the left side of face, and the other VAS for the right side of the face. Least pain on VAS is at the 0 mm mark, and worst pain is at the 100 mm mark. Objective is to calculate the proportion of subjects that had a within-subject difference in the VAS (Perlane minus Perlan-L) of at least 10 mm at injection together with a 95% confidence interval. The objective was to show that the confidence interval lay above 50%.', 'otherNumAtRisk': 60, 'otherNumAffected': 60, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Perlane', 'description': 'Split face design with each subject receiving Perlane on one side of the face and Perlane-L on the other. After treatments the patient scores pain experienced on a 2 VAS scales. One VAS represents pain on the left side of face, and the other VAS for the right side of the face. Least pain on VAS is at the 0 mm mark, and worst pain is at the 100 mm mark. Objective is to calculate the proportion of subjects that had a within-subject difference in the VAS (Perlane minus Perlan-L) of at least 10 mm at injection together with a 95% confidence interval. The objective was to show that the confidence interval lay above 50%.', 'otherNumAtRisk': 60, 'otherNumAffected': 60, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 36, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 33, 'numAffected': 33}], 'organSystem': 'General disorders'}, {'term': 'Redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 34, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 31, 'numAffected': 31}], 'organSystem': 'General disorders'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 42, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 39, 'numAffected': 39}], 'organSystem': 'General disorders'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 26, 'numAffected': 26}], 'organSystem': 'General disorders'}, {'term': 'Tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 50, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 49, 'numAffected': 49}], 'organSystem': 'General disorders'}, {'term': 'Itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'General disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Treatment Difference in VAS (Perlane Side - Perlane-L Side) With Difference in VAS >= 10 mm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Perlane-L and Perlane', 'description': 'Split face design with each subject receiveing Perlane on one side of the face and Perlane-L on the other.'}], 'classes': [{'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000', 'lowerLimit': '86.1', 'upperLimit': '99'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After Injection on Day of Treatment', 'unitOfMeasure': 'Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "This is a split-face design. Perlane and Perlane with Lidocaine was applied to different sides of the subject's face. A total of 60 subjects received both products. The study evaluated which side of the face has less pain, as measured by the Visual Analogue Scale (VAS). Least pain on VAS scale is at 0 mm mark and worst pain is 100 mm mark."}, {'type': 'SECONDARY', 'title': 'Number of Subjects Showing Wrinkle Improvement at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Perlane-L', 'description': 'Split face design with each subject receiving Perlane on one side of the face and Perlane-L on the other. After treatments the patient scores pain experienced on a 2 VAS scales. One VAS represents pain on the left side of face, and the other VAS for the right side of the face. Least pain on VAS is at the 0 mm mark, and worst pain is at the 100 mm mark. Objective is to calculate the proportion of subjects that had a within-subject difference in the VAS (Perlane minus Perlan-L) of at least 10 mm at injection together with a 95% confidence interval. The objective was to show that the confidence interval lay above 50%.'}, {'id': 'OG001', 'title': 'Perlane', 'description': 'Split face design with each subject receiving Perlane on one side of the face and Perlane-L on the other. After treatments the patient scores pain experienced on a 2 VAS scales. One VAS represents pain on the left side of face, and the other VAS for the right side of the face. Least pain on VAS is at the 0 mm mark, and worst pain is at the 100 mm mark. Objective is to calculate the proportion of subjects that had a within-subject difference in the VAS (Perlane minus Perlan-L) of at least 10 mm at injection together with a 95% confidence interval. The objective was to show that the confidence interval lay above 50%.'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '58', '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': 'Perlane-L and Perlane', 'description': 'Split face design with each subject receiveing Perlane on one side of the face and Perlane-L on the other.'}], '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': 'Perlane and Perlane-L', 'description': 'Split face design with each subject receiveing Perlane on one side of the face and Perlane-L on the other.'}], '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': '53.4', 'spread': '8.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '56', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', '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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-01', 'studyFirstSubmitDate': '2009-01-14', 'resultsFirstSubmitDate': '2010-08-25', 'studyFirstSubmitQcDate': '2009-01-14', 'lastUpdatePostDateStruct': {'date': '2010-11-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-11-01', 'studyFirstPostDateStruct': {'date': '2009-01-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Difference in VAS (Perlane Side - Perlane-L Side) With Difference in VAS >= 10 mm', 'timeFrame': 'After Injection on Day of Treatment'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects Showing 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 study that compares Perlane to Perlane with Lidocaine while correcting wrinkles in the area around your nose.', 'detailedDescription': 'This is a split-face design. All 60 subjects receive Perlane on one side of their face, and Perlane-L on the other. Subjects and the investigator is blinded to which side of face receives which product. These are one time injections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Same Wrinkle Severity Rating Scale score at both Nasolabial Folds (either both Moderate \\[3\\] or both Severe \\[4\\])\n\nExclusion Criteria:\n\n* Active or chronic skin disease, inflammation or related conditions, near or on the Nasolabial Folds\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 Nasolabial Fold area'}, 'identificationModule': {'nctId': 'NCT00823069', 'briefTitle': 'Safety Study That Compares Perlane to Perlane With Lidocaine (Perlane-L) While Correcting Wrinkles in the Area Around Your Nose', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medicis Global Service Corporation'}, 'officialTitle': 'A Randomized, Double-Blind Study Comparing Safety and Tolerability of Perlane® With and Without Addition of 0.3% Lidocaine HCL During Correction of Nasolabial Folds', 'orgStudyIdInfo': {'id': 'MA-1400-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Perlane and Perlane-L', 'description': 'This is a split-face design injecting both Perlane and Perlane-L injectable gels, administered once. Each subject received Perlane-L on one side of the face, and Perlane on the other. Subjects were blinded to which side of their face receive Perlane or Perlane-L. The study was randomized and treatments successive.', 'interventionNames': ['Device: Perlane and Perlane-L']}], 'interventions': [{'name': 'Perlane and Perlane-L', 'type': 'DEVICE', 'otherNames': ['Each subject received both Perlane-L and Perlane.'], 'description': 'This is a split face design and each subject received both Perlane-L and Perlane. Treatments were blinded, randomized, and successive.', 'armGroupLabels': ['Perlane and Perlane-L']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'city': 'Hunt Valley', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.49983, 'lon': -76.64108}}, {'city': 'Mount Cisco', 'state': 'New York', 'country': 'United States'}], 'overallOfficials': [{'name': 'Mary Sanstead', 'role': 'STUDY_CHAIR', 'affiliation': 'Medicis Global Pharmaceutical'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medicis Global Service Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Q-Med Scandinavia, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Mary Sanstead, Clinical Study Manager', 'oldOrganization': 'Medicis Global Services'}}}}