Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
Study NCT ID:
NCT01776606
Status:
COMPLETED
Last Update Posted:
2014-05-07
First Post:
2013-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of Botulinum Toxin Type A for Moderate to Severe Crow's Feet 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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 247}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'dispFirstSubmitDate': '2013-08-09', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-14', 'studyFirstSubmitDate': '2013-01-18', 'dispFirstSubmitQcDate': '2013-08-19', 'studyFirstSubmitQcDate': '2013-01-23', 'dispFirstPostDateStruct': {'date': '2013-08-27', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite endpoint based upon the investigator global assessment and patient assessment of severity of lateral canthal lines', 'timeFrame': 'Week 4'}], 'secondaryOutcomes': [{'measure': 'Proportion of subjects with 2 point or greater improvement from baseline using the Investigator Global Assessment', 'timeFrame': 'Week 4'}, {'measure': 'Proportion of subjects with 1 point or greater improvement from baseline using the Investigator Global Assessment', 'timeFrame': 'Week 4'}, {'measure': 'Proportion of subjects with a 2 point or greater improvement from baseline using the Patient Severity Assessment', 'timeFrame': 'Week 4'}]}, 'conditionsModule': {'conditions': ['Skin Aging']}, 'descriptionModule': {'briefSummary': "This study will evaluate the efficacy and safety of botulinum toxin type A compared to placebo control for the treatment of moderate to severe crow's feet lines."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Moderate to severe crow's feet lines\n* Female or male, 18 to 65 years of age and in good general health\n* Women of childbearing potential (WOCBP) must agree to use an effective method of birth control during the course of the study\n\nExclusion Criteria:\n\n* Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A\n* Muscle weakness or paralysis, particularly in the area receiving study treatment\n* Active skin disease or irritation at the treatment area\n* Deep dermal scarring, or inability to smooth out the crow's feet lines to be treated by manually spreading the skin apart\n* Treatment with botulinum toxin type A for crow's feet lines in the last 6 months"}, 'identificationModule': {'nctId': 'NCT01776606', 'acronym': 'RADIANT', 'briefTitle': "Efficacy and Safety Study of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines", 'organization': {'class': 'INDUSTRY', 'fullName': 'Revance Therapeutics, Inc.'}, 'orgStudyIdInfo': {'id': 'RT001-CL019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dose A', 'description': 'Dose A: Botulinum toxin type A', 'interventionNames': ['Drug: Botulinum Toxin Type A']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Dose B', 'description': 'Dose B: Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Botulinum Toxin Type A', 'type': 'DRUG', 'description': 'Botulinum Toxin Type A, Dose A; dose applied to the lateral canthal lines', 'armGroupLabels': ['Dose A']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo, Dose B; dose applied to the lateral canthal lines', 'armGroupLabels': ['Dose B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Dermatology Research Institute', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Revance Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}