Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-26 @ 4:13 PM
Study NCT ID:
NCT01358695
Status:
COMPLETED
Last Update Posted:
2013-07-01
First Post:
2011-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial To Evaluate ANT-1207 In Subjects With Crow's Feet
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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'dispFirstSubmitDate': '2013-06-21', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-21', 'studyFirstSubmitDate': '2011-05-20', 'dispFirstSubmitQcDate': '2013-06-21', 'studyFirstSubmitQcDate': '2011-05-20', 'dispFirstPostDateStruct': {'date': '2013-07-01', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-07-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Efficacy will be assessed by Investigator's Global Assessment Score", 'timeFrame': '2 weeks', 'description': 'Wrinkle scale with definitions of severity'}], 'secondaryOutcomes': [{'measure': 'Subject Self Assessment (SSA) scale', 'timeFrame': '2 Weeks', 'description': 'Change from Baseline in the Subject Self Assessment scale'}, {'measure': 'Investigator Global Assessment scale', 'timeFrame': 'Week 1, 2, 4, 8, 12', 'description': 'Change from Baseline in wrinkle scale assessment at all other timepoints'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lateral Canthal Lines', "Crow's Feet"], 'conditions': ['Lateral Canthal Lines', "Crow's Feet"]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to provide evidence of the safety, tolerance, and efficacy of ANT-1207 in the treatment of Crow's Feet."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* mild to moderate Crow's Feet wrinkles (IGA 2-3) at rest\n* moderate to severe Crow's Feet (IGA 3-4) on contraction\n* willingness to refrain from any product affecting skin remodeling\n* female subjects must be not pregnant and non-lactating\n\nExclusion Criteria:\n\n* history of peri-ocular surgery, brow lift or related procedures\n* procedures affecting the lateral canthal region in the prior 12 months\n* application of topical prescription medication to the treatment area\n* female subjects who are pregnant or are nursing a child"}, 'identificationModule': {'nctId': 'NCT01358695', 'briefTitle': "Clinical Trial To Evaluate ANT-1207 In Subjects With Crow's Feet", 'organization': {'class': 'INDUSTRY', 'fullName': 'Anterios Inc.'}, 'officialTitle': 'Clinical Trial To Evaluate ANT-1207 In Subjects With Lateral Canthal Lines', 'orgStudyIdInfo': {'id': 'ANT-1207-201-LCL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Comparator', 'interventionNames': ['Biological: ANT-1207', 'Biological: Botulinum Toxin Type A']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 1', 'description': 'Dose 1', 'interventionNames': ['Biological: ANT-1207', 'Biological: Botulinum Toxin, Type A', 'Biological: Botulinum Toxin Type A']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 2', 'description': 'Dose 2', 'interventionNames': ['Biological: ANT-1207', 'Biological: Botulinum Toxin, Type A', 'Biological: Botulinum Toxin Type A']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 3', 'description': 'Dose 3', 'interventionNames': ['Biological: ANT-1207', 'Biological: Botulinum Toxin, Type A', 'Biological: Botulinum Toxin Type A']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 4', 'description': 'Dose 4', 'interventionNames': ['Biological: Botulinum Toxin, Type A', 'Biological: Botulinum Toxin Type A']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 5', 'description': 'Dose 5', 'interventionNames': ['Biological: Botulinum Toxin, Type A', 'Biological: Botulinum Toxin Type A']}], 'interventions': [{'name': 'ANT-1207', 'type': 'BIOLOGICAL', 'description': 'The interventions differ by dose of investigational product applied.', 'armGroupLabels': ['Dose 1', 'Dose 2', 'Dose 3', 'Placebo Comparator']}, {'name': 'Botulinum Toxin, Type A', 'type': 'BIOLOGICAL', 'description': 'The interventions differ by dose of investigational product applied.', 'armGroupLabels': ['Dose 1', 'Dose 2', 'Dose 3', 'Dose 4', 'Dose 5']}, {'name': 'Botulinum Toxin Type A', 'type': 'BIOLOGICAL', 'description': 'The interventions differ by dose of investigational product applied.', 'armGroupLabels': ['Dose 1', 'Dose 2', 'Dose 3', 'Dose 4', 'Dose 5', 'Placebo Comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Total Skin & Beauty Dermatology Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Baumann Cosmetic & Research Institute', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Palm Beach Esthetic Dermatology and Laser Center', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'William Coleman III, MD, APMC', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '10010', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Gramercy Park Dermatology', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27519', 'city': 'Cary', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Cary Skin Care', 'geoPoint': {'lat': 35.79154, 'lon': -78.78112}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anterios Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}