Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2026-01-04 @ 6:58 PM
Study NCT ID:
NCT02108158
Status:
COMPLETED
Last Update Posted:
2022-08-25
First Post:
2014-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety and Efficacy Study of Different Injections Volumes of Botulinum Toxin Type A, Azzalure, in the Glabellar Lines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C542869', 'term': 'abobotulinumtoxinA'}, {'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-24', 'studyFirstSubmitDate': '2014-03-05', 'studyFirstSubmitQcDate': '2014-04-04', 'lastUpdatePostDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Assessment of severity of glabellar lines at rest and at maximum frown using the Merz Aesthetic 5-point scale', 'timeFrame': 'Day 0, 1, 3, 7, 14, month 3, 4 and 6', 'description': 'To evaluate effect on glabellar line severity'}, {'measure': 'Adverse Event reporting', 'timeFrame': 'Day 0-180', 'description': 'To evaluate long term safety throughout the study period'}, {'measure': 'Compound Muscle Action Potential (CMAP) reduction as percent of baseline CMAP measurement', 'timeFrame': 'Day 0, 1, 3, 7, month 1, 3 and 6', 'description': 'To evaluate the Compound Muscle Action Potential using electroneurography'}], 'primaryOutcomes': [{'measure': 'Assessment of severity of glabellar lines at rest and at maximum frown using the Merz Aesthetic 5-point scale. (However no primary outcome measure is defined in the study protocol)', 'timeFrame': 'Month 1', 'description': 'To evaluate effect on glabellar line severity'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Glabellar Frown Lines']}, 'descriptionModule': {'briefSummary': 'A randomized, evaluator-blinded, comparative, study to evaluate the efficacy and safety of different injection volumes of botulinum toxin type A, Azzalure, in the glabellar lines.', 'detailedDescription': 'Clarification regarding injection volumes for the different study groups:\n\nSubjects will be randomized to Group A or Group B (1:1).\n\n* Group A: 0,63ml NaCl will be used to reconstitute toxin in the vial. 0,05mL will be injected (equal to a dose of 10s.U.)\n* Group B: 1,25ml NaCl will be used to reconstitute toxin in the vial. 0,1 mL will be injected (equal to a dose of 10s.U.).\n\nThe two different reconstitution volumes (each containing a dose of 10s.U. botulinum toxin A) will be compared as described under objectives.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Women, 18 to 64 years of age\n* Subjects seeking treatment for moderate to severe glabellar lines when the severity of these lines has an important psychological impact on the subject, as determined by the investigator.\n\nKey Exclusion Criteria:\n\n* Subjects previously treated with any botulinum toxin product.\n* Pregnant or breast feeding women or women intending to get pregnant in the next 12 months.\n* Subjects with signs and symptoms of eyelid or brow ptosis or signs of compensatory frontalis muscle activity, as judged by the investigator.\n* Subjects with clinical or subclinical neuromuscular junctional disorders (e.g. myasthenia gravis, Lambert Eaton syndrome or amyotrophic lateral sclerosis) or a history of dysphagia or aspiration.\n* Subjects with previous or current diagnosis of Bell's paresis.\n* Subjects with known bleeding disorders or subjects who are taking thrombolytics or anticoagulants.\n* Subjects who are taking anticholinergics or aminoglycoside antibiotics.\n* Any prior surgery in the facial area that, in the opinion of the investigator, may interfere with the results.\n* Subjects treated with fillers, HA filler or permanent filler, in the upper face one year or less from screening."}, 'identificationModule': {'nctId': 'NCT02108158', 'briefTitle': 'A Safety and Efficacy Study of Different Injections Volumes of Botulinum Toxin Type A, Azzalure, in the Glabellar Lines', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'A Randomized, Evaluator-blinded, Comparative Study to Evaluate the Efficacy and Safety of Different Injection Volumes of Botulinum Toxin Type A, Azzalure, in the Glabellar Lines', 'orgStudyIdInfo': {'id': '05PF1311'}, 'secondaryIdInfos': [{'id': '2013-004646-42', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Azzalure 10 Speywood units/injection', 'description': 'Azzalure (botulinum toxin type A), powder for solution for injection, Total dose 50 s.U (5 x 10s.U)', 'interventionNames': ['Drug: Azzalure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Azzalure, 10 Speywood units/injection', 'description': 'Azzalure (botulinum toxin type A), powder for solution for injection, Total dose 50 s.U (5 x 10s.U)', 'interventionNames': ['Drug: Azzalure']}], 'interventions': [{'name': 'Azzalure', 'type': 'DRUG', 'otherNames': ['botulinum toxin type A'], 'armGroupLabels': ['Azzalure 10 Speywood units/injection', 'Azzalure, 10 Speywood units/injection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Göteborgs Plastikkirurgiska Center', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Anna Neuromuskulär Konsult', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Anna Rostedt Punga, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ANNA Neuromuskulär Konsult'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galderma R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}