Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-02-24 @ 10:20 PM
Study NCT ID:
NCT01529203
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2012-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Subjects' Satisfaction on Pan Facial Aesthetic Enhancement After Treatment With Azzalure® and the Restylane® Range
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}, {'id': 'C542869', 'term': 'abobotulinumtoxinA'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'may.ma@galderma.com', 'phone': '(33) 4 92 38 67 33', 'title': 'Clinical Project Manager', 'organization': 'Galderma'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Azzalure and Restylane', 'description': 'All subjects will be injected with Azzalure and Restylane\n\nBotulinum Toxin Type A (Azzalure): Powder for solution for injection\n\nRestylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)', 'otherNumAtRisk': 60, 'otherNumAffected': 18, 'seriousNumAtRisk': 60, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Injection site haematoma', 'notes': 'administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Infections and infestations'}, {'term': 'contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'Skin swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders'}], 'seriousEvents': [{'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subject Satisfaction for the Full Face', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azzalure and Restylane', 'description': 'All subjects will be injected with Azzalure and Restylane\n\nBotulinum Toxin Type A (Azzalure): Powder for solution for injection\n\nRestylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)'}], 'classes': [{'title': 'satisfied or very satisfied', 'categories': [{'measurements': [{'value': '92.9', 'groupId': 'OG000'}]}]}, {'title': 'neutral', 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'description': "based on the subject's satisfaction questionnaire", 'unitOfMeasure': 'percentage of total subjects', 'reportingStatus': 'POSTED', 'populationDescription': "only the 56 subjects who had provided answers in the subject's satisfaction questionnaire were included in the analysis"}, {'type': 'SECONDARY', 'title': 'Global Aesthetic Improvement From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azzalure and Restylane', 'description': 'All subjects will be injected with Azzalure and Restylane\n\nBotulinum Toxin Type A (Azzalure): Powder for solution for injection\n\nRestylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Much or very much improved', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 3', 'description': 'The scale responses are: -1 indicating "worse", 0 indicating "no change", 1 indicating "improved", 2 indicating "much improved" and 3 indicating "very much improved".', 'unitOfMeasure': 'percentage of total subjects', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Related Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azzalure and Restylane', 'description': 'All subjects will be injected with Azzalure and Restylane\n\nBotulinum Toxin Type A (Azzalure): Powder for solution for injection\n\nRestylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'description': 'Number of subjects reporting related adverse events', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Azzalure and Restylane', 'description': 'All subjects will be injected with Azzalure and Restylane\n\nBotulinum Toxin Type A (Azzalure): Powder for solution for injection\n\nRestylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Azzalure and Restylane', 'description': 'All subjects will be injected with Azzalure and Restylane\n\nBotulinum Toxin Type A (Azzalure): Powder for solution for injection\n\nRestylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.6', 'spread': '7.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'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': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '60', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-16', 'studyFirstSubmitDate': '2012-01-30', 'resultsFirstSubmitDate': '2014-03-24', 'studyFirstSubmitQcDate': '2012-02-07', 'lastUpdatePostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-03-24', 'studyFirstPostDateStruct': {'date': '2012-02-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subject Satisfaction for the Full Face', 'timeFrame': 'Month 6', 'description': "based on the subject's satisfaction questionnaire"}], 'secondaryOutcomes': [{'measure': 'Global Aesthetic Improvement From Baseline', 'timeFrame': 'Week 3', 'description': 'The scale responses are: -1 indicating "worse", 0 indicating "no change", 1 indicating "improved", 2 indicating "much improved" and 3 indicating "very much improved".'}, {'measure': 'Related Adverse Event', 'timeFrame': 'Month 6', 'description': 'Number of subjects reporting related adverse events'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Aging']}, 'descriptionModule': {'briefSummary': "The aim of this study is to assess subjects' satisfaction linked to the pan facial management of rejuvenation with injections of Azzalure® and Restylane® fillers.\n\nThis will be an open, multi-centre study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Main Inclusion Criteria:\n\n* Male or female subjects, aged 18 to 64 years, seeking treatment for correction of dynamic wrinkles of the upper third of the face and correction of facial volume loss, and meeting other specific eligibility criteria\n\nMain Exclusion Criteria:\n\n* Female subject who is pregnant, nursing or planning a pregnancy during the study\n* Subject with any contraindications to the injection of hyaluronic acid (see package inserts)\n* Subject with any contraindications to the injection of botulinum toxin (see package insert)\n* Subject with a personal history of allergic/anaphylactic reactions including hypersensitivity to crossed-linked hyaluronic acid or botulinum toxin\n* Concurrent treatment that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of at least one of the study treatments\n* Subject with a history of dissatisfaction with facial aesthetic procedures involving dermal implant injections or subject with unattainable expectations\n* Subject currently enrolled in another investigational study or who participated in such a study in the past 30 days prior to baseline visit"}, 'identificationModule': {'nctId': 'NCT01529203', 'acronym': 'FIRST', 'briefTitle': "Subjects' Satisfaction on Pan Facial Aesthetic Enhancement After Treatment With Azzalure® and the Restylane® Range", 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': "Subjects' Satisfaction on Pan Facial Aesthetic Enhancement After Treatment With Azzalure® and the Restylane® Range", 'orgStudyIdInfo': {'id': 'RD.03.SPR.29097'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Azzalure and Restylane', 'description': 'All subjects will be injected with Azzalure and Restylane', 'interventionNames': ['Drug: Botulinum Toxin Type A (Azzalure)', 'Device: Restylane ranges']}], 'interventions': [{'name': 'Botulinum Toxin Type A (Azzalure)', 'type': 'DRUG', 'description': 'Powder for solution for injection', 'armGroupLabels': ['Azzalure and Restylane']}, {'name': 'Restylane ranges', 'type': 'DEVICE', 'description': 'Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)', 'armGroupLabels': ['Azzalure and Restylane']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'country': 'France', 'facility': 'Galderma investigational site', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Metz', 'country': 'France', 'facility': 'Galderma investigational site', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Galderma investigational site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Galderma investigational site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Street', 'country': 'United Kingdom', 'facility': 'Galderma investigational site', 'geoPoint': {'lat': 51.12472, 'lon': -2.74}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galderma R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}