Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-03-03 @ 3:53 PM
Study NCT ID:
NCT02303002
Status:
COMPLETED
Last Update Posted:
2016-03-09
First Post:
2014-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Botulinum Toxin Type A for Injection to Treat Glabellar Lines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 268}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-08', 'studyFirstSubmitDate': '2014-11-25', 'studyFirstSubmitQcDate': '2014-11-26', 'lastUpdatePostDateStruct': {'date': '2016-03-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects assessed as responders by investigator assessment of severity of glabellar lines at maximum frown', 'timeFrame': 'Week 24'}, {'measure': 'Duration of response assessed by investigator assessment of severity of glabellar lines at maximum frown from the date of injection to when subject reverts to baseline severity', 'timeFrame': 'Up to Week 36'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Glabellar Frown Lines']}, 'referencesModule': {'references': [{'pmid': '33065952', 'type': 'DERIVED', 'citation': 'Bertucci V, Humphrey S, Carruthers J, Solish N, Muhn C, Swift A, Rubio RG, Shears G, Rosen N. Comparing Injectable DaxibotulinumtoxinA and OnabotulinumtoxinA in Moderate and Severe Glabellar Lines: Additional Analyses From a Phase 2, Randomized, Dose-Ranging, Double-Blind, Multicenter Study. Dermatol Surg. 2017 Dec;43 Suppl 3:S262-S273. doi: 10.1097/DSS.0000000000001364.'}, {'pmid': '28614091', 'type': 'DERIVED', 'citation': 'Carruthers J, Solish N, Humphrey S, Rosen N, Muhn C, Bertucci V, Swift A, Metelitsa A, Rubio RG, Waugh J, Quiring J, Shears G, Carruthers A. Injectable DaxibotulinumtoxinA for the Treatment of Glabellar Lines: A Phase 2, Randomized, Dose-Ranging, Double-Blind, Multicenter Comparison With OnabotulinumtoxinA and Placebo. Dermatol Surg. 2017 Nov;43(11):1321-1331. doi: 10.1097/DSS.0000000000001206.'}]}, 'descriptionModule': {'briefSummary': 'This is a safety and efficacy study of botulinum toxin type A in subjects with glabellar frown lines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate or severe glabellar frown lines\n* Female or male, 30 to 65 years of age in good general health\n* Women of childbearing potential must agree to use an effective method of birth control during the course of the study\n* Willing to refrain from receipt of facial fillers, laser treatments or use of products that affect skin remodeling and causes an active dermal response\n\nExclusion Criteria:\n\n* Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A such as amyotrophic lateral sclerosis and motor neuropathy, Lambert-Eaton syndrome, and myasthenia gravis\n* Muscle weakness or paralysis, particularly in the treatment area\n* Active skin disease or infections or irritation at the treatment area\n* Facial asymmetry, deep dermal scarring, or inability to substantially lessen the glabellar frown lines by manually spreading them apart\n* Treatment with Botulinum Toxin Type A in the face in the last 6 months or in the last 3 months anywhere in the body'}, 'identificationModule': {'nctId': 'NCT02303002', 'briefTitle': 'Efficacy and Safety of Botulinum Toxin Type A for Injection to Treat Glabellar Lines', 'organization': {'class': 'INDUSTRY', 'fullName': 'Revance Therapeutics, Inc.'}, 'orgStudyIdInfo': {'id': 'RT002-CL002'}, 'secondaryIdInfos': [{'id': 'CTA Control No. 179120', 'type': 'OTHER', 'domain': 'Health Canada'}, {'id': 'File No. 9427-R1312\\1-22C', 'type': 'OTHER', 'domain': 'Health Canada'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose A', 'description': 'Dose A: Botulinum Toxin Type A', 'interventionNames': ['Biological: Botulinum Toxin Type A']}, {'type': 'EXPERIMENTAL', 'label': 'Dose B', 'description': 'Dose B: Botulinum Toxin Type A', 'interventionNames': ['Biological: Botulinum Toxin Type A']}, {'type': 'EXPERIMENTAL', 'label': 'Dose C', 'description': 'Dose C: Botulinum Toxin Type A', 'interventionNames': ['Biological: Botulinum Toxin Type A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dose D', 'description': 'Dose D: Botulinum Toxin Type A', 'interventionNames': ['Biological: Active Comparator botulinum toxin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Dose E', 'description': 'Dose E: Placebo', 'interventionNames': ['Biological: Placebo Comparator']}], 'interventions': [{'name': 'Botulinum Toxin Type A', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection (IM)', 'armGroupLabels': ['Dose A', 'Dose B', 'Dose C']}, {'name': 'Active Comparator botulinum toxin', 'type': 'BIOLOGICAL', 'description': 'IM injection', 'armGroupLabels': ['Dose D']}, {'name': 'Placebo Comparator', 'type': 'BIOLOGICAL', 'description': 'IM injection', 'armGroupLabels': ['Dose E']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Revance Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}