Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2026-04-01 @ 5:48 PM
Study NCT ID:
NCT00977704
Status:
COMPLETED
Last Update Posted:
2013-06-10
First Post:
2009-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Restylane and Perlane in the Correction of Peri-Oral Wrinkles
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsQuery@Medicis.com', 'title': 'Head of Clinical Trials', 'organization': 'Medicis R&D Clinical Research Department'}, 'certainAgreement': {'otherDetails': "Researcher agree to submit to Medicis for Medicis' prior review and written approval, which approval shall not be unreasonably withheld, any written publication utilizing results or other data generated from this study at least ninety days, or, for abstracts, at least thirty days before such publication is presented or submitted for publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Perlane and Restylane', 'description': 'Perlane and Restylane used open label to correct peri-oral wrinkles', 'otherNumAtRisk': 20, 'otherNumAffected': 20, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 27, 'numAffected': 19}], 'organSystem': 'General disorders'}, {'term': 'Tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 20, 'numAffected': 10}], 'organSystem': 'General disorders'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'General disorders'}, {'term': 'Redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Local and Systemic Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Restylane and Perlane', 'description': 'Single arm safety study of subjects receiving Restylane and Perlane.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2-weeks', 'description': 'To examine the safety of Restylane and Perlane when used in the treatment of facial wrinkles and folds by identification of the point incidence of:\n\n* All local adverse events as reported by healthcare professional\n* All systemic adverse events (related and unrelated)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary object is to examine safety using descriptive statistics (frequency and percentage). Analysis was on the Intent to treat Population of all treated subjects, including those subjects for whom only incomplete data were available. No considerations (e.g. imputation) were made for missing data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Perlane and Restylane', 'description': 'Perlane and Restylane used open label to correct peri-oral wrinkles'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Perlane and Restylane', 'description': 'Perlane and Restylane used open label to correct peri-oral wrinkles'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.6', 'spread': '4.04', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-07', 'studyFirstSubmitDate': '2009-09-14', 'resultsFirstSubmitDate': '2011-12-22', 'studyFirstSubmitQcDate': '2009-09-15', 'lastUpdatePostDateStruct': {'date': '2013-06-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-05-07', 'studyFirstPostDateStruct': {'date': '2009-09-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local and Systemic Adverse Events', 'timeFrame': '2-weeks', 'description': 'To examine the safety of Restylane and Perlane when used in the treatment of facial wrinkles and folds by identification of the point incidence of:\n\n* All local adverse events as reported by healthcare professional\n* All systemic adverse events (related and unrelated)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Correction of peri-oral wrinkles'], 'conditions': ['Peri-oral Wrinkles']}, 'descriptionModule': {'briefSummary': 'This is an open-label study to assess safety using Restylane and Perlane in the correction of facial wrinkles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Same Wrinkle Severity (either both Moderate \\[3\\] or both Severe \\[4\\]) of marionette lines and upper peri-oral rhytids\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': 'NCT00977704', 'briefTitle': 'Study of Restylane and Perlane in the Correction of Peri-Oral Wrinkles', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medicis Global Service Corporation'}, 'officialTitle': 'An Open-label Study of the Safety of Restylane and Perlane in the Correction of Peri-oral Wrinkles.', 'orgStudyIdInfo': {'id': 'MA-1900-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Restylane and Perlane', 'description': 'Restylane and Perlane administered by injection. Recommended volume of 6.0 mL. Injection on study day 1 with an optional touch up on study day 14.', 'interventionNames': ['Device: Restylane and Perlane']}], 'interventions': [{'name': 'Restylane and Perlane', 'type': 'DEVICE', 'armGroupLabels': ['Restylane and Perlane']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Call For Information', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '75254', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Call For Information', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Mary Sanstead, RN, BSN, CCRC', 'role': 'STUDY_CHAIR', 'affiliation': 'Medicis Global Services'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medicis Global Service Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}