Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2026-01-24 @ 4:07 AM
Study NCT ID:
NCT02297503
Status:
COMPLETED
Last Update Posted:
2022-08-26
First Post:
2014-10-31
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Treatment With Azzalure, Restylane/Emervel Filler and Restylane Skinbooster
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C542869', 'term': 'abobotulinumtoxinA'}, {'id': 'D001905', 'term': 'Botulinum Toxins'}], 'ancestors': [{'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': 'maria.norberg@galderma.com', 'phone': '+46184891267', 'title': 'Maria Norberg', 'organization': 'Galderma'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Group A (Azzalure): After Single Treatment', 'description': 'Group A received Azzalure alone as initial single treatment, and thereafter two combined treatments. Events reported in this section occurred after the single treatment was given but before the 1st combined treatment was given.', 'otherNumAtRisk': 29, 'otherNumAffected': 1, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group B (Filler): After Single Treatment', 'description': 'Group B received filler alone as initial single treatment, and thereafter two combined treatments. Events reported in this section occurred after the single treatment was given but before the 1st combined treatment was given.', 'otherNumAtRisk': 31, 'otherNumAffected': 4, 'seriousNumAtRisk': 31, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Group A: After 1st Combined Treatment', 'description': 'Group A received Azzalure alone as initial single treatment, and thereafter two combined treatments. Events reported in this section occurred after the 1st combined treatment was given.', 'otherNumAtRisk': 28, 'otherNumAffected': 15, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Group B: After 1st Combined Treatment', 'description': 'Group B received filler alone as initial single treatment, and thereafter two combined treatments. Events reported in this section occurred after the 1st combined treatment was given.', 'otherNumAtRisk': 28, 'otherNumAffected': 13, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Group A: After 2nd Combined Treatment', 'description': 'Group A received Azzalure alone as initial single treatment, and thereafter two combined treatments. Events reported in this section occurred after the 2nd combined treatment was given.', 'otherNumAtRisk': 28, 'otherNumAffected': 9, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Group B: After 2nd Combined Treatment', 'description': 'Group B received filler alone as initial single treatment, and thereafter two combined treatments.Events reported in this section occurred after the 2nd combined treatment was given.', 'otherNumAtRisk': 28, 'otherNumAffected': 9, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Implant site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 14, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Implant site oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'VII nerve paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Inflammatory reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Lump', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Nephritic colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Skin reaction', 'notes': 'Redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Common cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}], 'seriousEvents': [{'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28}, {'groupId': 'EG005', 'numAtRisk': 28}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Improvement in Global Facial Aesthetic Appearance at 7 Months (Review of Photographs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azzalure Alone as Initial Treatment', 'description': 'Subjects receiving Azzalure as initial treatment'}, {'id': 'OG001', 'title': 'Filler Alone as Initial Treatment', 'description': 'Subjects receiving HA filler as initial treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 months', 'description': 'To evaluate "Global facial aesthetic appearance" at 7 months compared to at 1 month, blinded evaluator review of photographs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Improvement in Global Facial Aesthetic Appearance at 1, 7 and 13 Months (Review of Photographs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azzalure Alone as Initial Treatment', 'description': 'Azzalure alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.'}, {'id': 'OG001', 'title': 'Filler Alone as Initial Treatment', 'description': 'Filler alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.'}], 'classes': [{'title': 'Superior Month 1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Superior Month 7', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Superior Month 13', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1, 7 and 13 months', 'description': 'To evaluate "Global facial aesthetic appearance" at 1, 7 and 13 months, blinded evaluator review of photographs from the respective visits.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Incorrectly taken photographs for six participants were excluded from analysis. Additionally two participants excluded because they were assessed different by all three evaluators.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Improved on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Blinded Evaluator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects'}], 'classes': [{'title': 'Improved Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'Improved Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}, {'title': 'Improved Month 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 1, Month 7, and Month 13', 'description': 'The 5-graded GAIS is used to assess the facial aesthetic improvement from baseline by responding to the question: "How would you describe the subject\'s global facial aesthetic appearance, compared to the photographs taken before treatment at baseline?" The scale grades are Very much improved, Much improved, Somewhat improved, No change, Worse. Improved subjects are those graded as Very much improved, Much improved, and Somewhat improved.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of analyzed subjects decreased over time due to drop-out of study subjects.\n\nData not presented "Per Arm", since statistical analysis was only performed on both groups combined after the combination treatments (since the groups receive the exact same treatment during the combination treatment).'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Satisfied With Overall Facial Appearance (Questionnaire)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azzalure Alone as Initial Treatment', 'description': 'Azzalure alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.'}, {'id': 'OG001', 'title': 'Filler Alone as Initial Treatment', 'description': 'Filler alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.'}], 'classes': [{'title': 'Satisfied Month 7', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Satisfied Month 13', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 7 and Month 13', 'description': 'Subjects answered the question "How satisfied are you today with the appearance of your face?" with "Very/somewhat satisfied", "Neither/nor", or "Very/somewhat dissatisfied". Number of subjects satisfied are those that answered "Very/somewhat satisfied".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects for Which the Investigator is Satisfied With Overall Facial Aesthetic Outcome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azzalure Alone as Initial Treatment', 'description': 'Azzalure alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.'}, {'id': 'OG001', 'title': 'Filler Alone as Initial Treatment', 'description': 'Filler alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.'}], 'classes': [{'title': 'Satisfied Month 7', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Satisfied Month 13', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 7 and Month 13', 'description': 'The Investigator answered the question "How satisfied are you with the overall facial aesthetic outcome for the subject?" with "Very/somewhat satisfied", "Neither/nor", or "Very/somewhat dissatisfied". Satisfied criteria is met for those subjects that the Investigator answered "Very/somewhat satisfied".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Had Improvement in Wrinkle Severity Score of Treated Glabellar Lines (Validated Photo Scales)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azzalure Alone as Initial Treatment', 'description': 'Azzalure alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.'}, {'id': 'OG001', 'title': 'Filler Alone as Initial Treatment', 'description': 'Filler alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.'}], 'classes': [{'title': 'Improved Month 7', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Improved Month 13', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 7 and Month 13', 'description': 'The wrinkle severity of the glabellar lines at maximum frown was evaluated by the investigator at baseline before first treatment and at follow-up visits. Validated photonumeric grading scales were used where each severity grade is illustrated by a set of photographs. The investigator performed the assessment live or by using 2D photographs from the present visit, together with the respective photo guide: 0 No glabella lines, 1 Mild glabella lines, 2 Moderate glabella lines, 3 Severe glabella lines, 4 Very severe glabella lines. Improved criteria is thus fulfilled for subjects receiving a lower score compared to baseline.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Perceived Age of Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azzalure Alone as Initial Treatment', 'description': 'Azzalure alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.'}, {'id': 'OG001', 'title': 'Filler Alone as Initial Treatment', 'description': 'Filler alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.'}], 'classes': [{'title': 'Difference Month 7/Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'Differerence Month 13/Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '2.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 and 7 months, and 1 and 13 months', 'description': 'To evaluate First impression and perceived age of subjects by evaluation of photos.\n\nChange between timepoints are reported. A negative value indicates that the participant is assessed to be younger at the specified visit compared to the assessment made at 1 month after single treatment.', 'unitOfMeasure': 'years', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Five participants excluded from analysis due to incorrectly taken photographs.'}, {'type': 'SECONDARY', 'title': 'Injected Filler Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Filler Alone as Initial Treatment', 'description': 'The participants randomized to receive filler alone as initial single treatment.'}, {'id': 'OG001', 'title': 'All Subjects', 'description': 'All subjects received filler at the combined treatments.'}], 'classes': [{'title': 'Single and first combined treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.98', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '1.92', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'Second combined treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.72', 'spread': '0.50', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Initial single treatment (baseline), first combined treatment (Month 6), and second combined treatment (Month 12)', 'description': 'To evaluate the filler volume injected at initial single treatment and at following repeated combined treatment', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For the initial single treatment, only the "Filler alone as initial treatment" participants received filler. At the two combination treatments, all subjects received filler. Data from the "Filler alone as initial treatment" participants are presented for the single treatment while data for all subjects are presented for the combination treatments.'}, {'type': 'SECONDARY', 'title': 'Adverse Event Reporting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azzalure Alone as Initial Treatment', 'description': 'Azzalure alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.'}, {'id': 'OG001', 'title': 'Filler Alone as Initial Treatment', 'description': 'Filler alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0-18 months', 'description': 'To evaluate safety throughout the study period', 'unitOfMeasure': 'Treatment related AEs', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Azzalure Alone as Initial Treatment', 'description': 'Azzalure alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.'}, {'id': 'FG001', 'title': 'Filler Alone as Initial Treatment', 'description': 'HA filler alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'Initial Single Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'First Combined Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'Second Combined Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Medical reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Azzalure Alone as Initial Treatment', 'description': 'Azzalulre alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.'}, {'id': 'BG001', 'title': 'Filler Alone as Initial Treatment', 'description': 'Filler alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '45.9', 'groupId': 'BG000', 'lowerLimit': '36', 'upperLimit': '50'}, {'value': '43.6', 'groupId': 'BG001', 'lowerLimit': '36', 'upperLimit': '49'}, {'value': '44.7', 'groupId': 'BG002', 'lowerLimit': '36', 'upperLimit': '50'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data on ethnicity only collected for the Swedish site.'}, {'title': 'Smoking', 'classes': [{'title': 'Smoker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Non smoker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'One participant withdrew consent after randomization and prior to first treatment. That participant is not included in the analyses.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-24', 'studyFirstSubmitDate': '2014-10-31', 'resultsFirstSubmitDate': '2019-06-25', 'studyFirstSubmitQcDate': '2014-11-20', 'lastUpdatePostDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-21', 'studyFirstPostDateStruct': {'date': '2014-11-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Improvement in Global Facial Aesthetic Appearance at 7 Months (Review of Photographs)', 'timeFrame': '7 months', 'description': 'To evaluate "Global facial aesthetic appearance" at 7 months compared to at 1 month, blinded evaluator review of photographs.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With Improvement in Global Facial Aesthetic Appearance at 1, 7 and 13 Months (Review of Photographs)', 'timeFrame': '1, 7 and 13 months', 'description': 'To evaluate "Global facial aesthetic appearance" at 1, 7 and 13 months, blinded evaluator review of photographs from the respective visits.'}, {'measure': 'Number of Participants Improved on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Blinded Evaluator', 'timeFrame': 'Month 1, Month 7, and Month 13', 'description': 'The 5-graded GAIS is used to assess the facial aesthetic improvement from baseline by responding to the question: "How would you describe the subject\'s global facial aesthetic appearance, compared to the photographs taken before treatment at baseline?" The scale grades are Very much improved, Much improved, Somewhat improved, No change, Worse. Improved subjects are those graded as Very much improved, Much improved, and Somewhat improved.'}, {'measure': 'Number of Subjects Satisfied With Overall Facial Appearance (Questionnaire)', 'timeFrame': 'Month 7 and Month 13', 'description': 'Subjects answered the question "How satisfied are you today with the appearance of your face?" with "Very/somewhat satisfied", "Neither/nor", or "Very/somewhat dissatisfied". Number of subjects satisfied are those that answered "Very/somewhat satisfied".'}, {'measure': 'Number of Subjects for Which the Investigator is Satisfied With Overall Facial Aesthetic Outcome', 'timeFrame': 'Month 7 and Month 13', 'description': 'The Investigator answered the question "How satisfied are you with the overall facial aesthetic outcome for the subject?" with "Very/somewhat satisfied", "Neither/nor", or "Very/somewhat dissatisfied". Satisfied criteria is met for those subjects that the Investigator answered "Very/somewhat satisfied".'}, {'measure': 'Number of Participants Who Had Improvement in Wrinkle Severity Score of Treated Glabellar Lines (Validated Photo Scales)', 'timeFrame': 'Month 7 and Month 13', 'description': 'The wrinkle severity of the glabellar lines at maximum frown was evaluated by the investigator at baseline before first treatment and at follow-up visits. Validated photonumeric grading scales were used where each severity grade is illustrated by a set of photographs. The investigator performed the assessment live or by using 2D photographs from the present visit, together with the respective photo guide: 0 No glabella lines, 1 Mild glabella lines, 2 Moderate glabella lines, 3 Severe glabella lines, 4 Very severe glabella lines. Improved criteria is thus fulfilled for subjects receiving a lower score compared to baseline.'}, {'measure': 'Change in Perceived Age of Subjects', 'timeFrame': '1 and 7 months, and 1 and 13 months', 'description': 'To evaluate First impression and perceived age of subjects by evaluation of photos.\n\nChange between timepoints are reported. A negative value indicates that the participant is assessed to be younger at the specified visit compared to the assessment made at 1 month after single treatment.'}, {'measure': 'Injected Filler Volume', 'timeFrame': 'Initial single treatment (baseline), first combined treatment (Month 6), and second combined treatment (Month 12)', 'description': 'To evaluate the filler volume injected at initial single treatment and at following repeated combined treatment'}, {'measure': 'Adverse Event Reporting', 'timeFrame': '0-18 months', 'description': 'To evaluate safety throughout the study period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Facial Aesthetic Treatment']}, 'descriptionModule': {'briefSummary': 'The efficacy and safety, as well as subject satisfaction will be evaluated after single treatment with Azzalure alone or Restylane/Emervel filler alone followed by repeated combined treatment with Azzalure, Restylane/Emervel filler and Restylane Skinbooster. Subjects will be followed for up to 18 months after initial treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Subjects aged 35 to 50 years old\n* Subjects with the intention to undergo facial aesthetic treatment and who are likely to benefit from a combination of injection treatments and the benefit can be shown by improvements in their global facial aesthetic appearance and satisfaction.\n* Subjects with nasolabial folds assessed as mild or moderate.\n* Subjects with glabellar lines assessed as moderate or severe, when the severity of the lines has an important psychological impact on the subject.\n* Subjects with signed informed consent.\n\nExclusion Criteria:\n\n* Subjects requiring treatment of forehead lines or crow´s feet.\n* Obvious facial sagging (major loss of facial fat/volume).\n* Signs or symptoms of eyelid ptosis or signs of compensatory frontalis muscle activity.\n* Heavily scarred or sun-damaged facial skin.\n* Active skin disease, inflammation or related conditions, such as infection, psoriasis and herpes zoster/herpes simplex near or on the areas to be treated.\n* Cancerous or pre-cancerous lesions in the areas to be treated.\n* Facial tissue augmenting therapy or revitalization treatment with hyaluronic acid (HA) or collagen, or botulinum toxin treatment during the last 12 months.\n* Procedures or treatments inducing an active dermal response such as laser, Intense Pulsed Light, chemical peeling, microdermabrasion, retinoids within the last 6 months.\n* Any aesthetic surgery of the face.\n* Permanent implant or aesthetic treatment with non-HA or non-collagen products in the face.\n* History of severe keloids and/or hypertrophic scars.\n* Neuromuscular junctional disorders (e.g. myasthenia gravis, Eaton Lambert syndrome or amyotrophic lateral sclerosis) or history of dysphagia and aspiration.\n* Known hypersensitivity to hyaluronic acid, botulinum toxin, lidocaine hydrochloride or other amide-type anesthetics.\n* History of autoimmune diseases.\n* Any medical condition that in the opinion of the investigator would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may affect the general condition or may require frequent medical treatment).\n* Concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation (e.g. aspirin or other nonsteroidal anti-inflammatory drugs \\[NSAIDs\\]), Omega-3 or vitamin E within 10 days before study treatment, or a history of bleeding disorders.\n* Immunosuppressive therapy, chemotherapy, or systemic corticosteroids within the last 3 months prior to baseline visit.\n* Female subjects who are pregnant or plan to become pregnant within the study timeframe, or who are nursing.'}, 'identificationModule': {'nctId': 'NCT02297503', 'briefTitle': 'Safety and Efficacy of Treatment With Azzalure, Restylane/Emervel Filler and Restylane Skinbooster', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'An Evaluator-blinded Multi-center Study of Combined Treatment With Azzalure, Restylane/Emervel Filler and Restylane Skinbooster as Compared to Single Treatment With Either Azzalure Alone or Restylane/Emervel Filler Alone', 'orgStudyIdInfo': {'id': '05DF1211'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Azzalure alone as single treatment', 'description': 'Azzalure alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.', 'interventionNames': ['Drug: Azzalure', 'Device: Restylane/Emervel filler', 'Device: Restylane Skinbooster']}, {'type': 'EXPERIMENTAL', 'label': 'Filler alone as single treatment', 'description': 'HA filler alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.', 'interventionNames': ['Drug: Azzalure', 'Device: Restylane/Emervel filler', 'Device: Restylane Skinbooster']}], 'interventions': [{'name': 'Azzalure', 'type': 'DRUG', 'otherNames': ['Botulinum toxin'], 'description': 'Glabellar lines', 'armGroupLabels': ['Azzalure alone as single treatment', 'Filler alone as single treatment']}, {'name': 'Restylane/Emervel filler', 'type': 'DEVICE', 'otherNames': ['Hyaluronic acid'], 'description': 'Facial tissue augmentation', 'armGroupLabels': ['Azzalure alone as single treatment', 'Filler alone as single treatment']}, {'name': 'Restylane Skinbooster', 'type': 'DEVICE', 'otherNames': ['Hyaluronic acid'], 'description': 'Facial skin rejuvenation', 'armGroupLabels': ['Azzalure alone as single treatment', 'Filler alone as single treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06160', 'city': 'Paris', 'state': 'Antibes', 'country': 'France', 'facility': 'Mediti Center', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '62000', 'city': 'Arras', 'country': 'France', 'facility': 'Centre Medical Saint-Jean', 'geoPoint': {'lat': 50.29301, 'lon': 2.78186}}, {'zip': '115 42', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Akademikliniken', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Philippe Kestemont, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinique Science et Beauté, Antibes, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galderma R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}