Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-01-04 @ 8:59 AM
Study NCT ID:
NCT03326856
Status:
COMPLETED
Last Update Posted:
2022-04-21
First Post:
2017-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ET-01 in Subjects With Lateral Canthal Lines
Sponsor:
Organization:
Raw JSON
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The same scale is used for the Investigator\'s Assessment as well as the Subject\'s Self Assessment. To count, both assessments (on contraction) have to be "responders" defined as Score ≤ 2.'}], 'secondaryOutcomes': [{'measure': 'Total Number of Observations With a Response Defined as IGA-C Score ≤ 2', 'timeFrame': 'Week 2, 4, 8,12,18', 'description': 'Total number of observations with a Score of ≤ 2 on the Investigators Global Assessment on Contraction, IGA-C, using the Crow\'s Feet Wrinkle Scale, where severity is scored between 0-4 (0=absent; 4=severe). To count, a "responder" is defined as Score ≤ 2. The observation period ranges from the earliest expected onset of action at Week 2 to the likely offset of action by Week 18.'}, {'measure': 'Total Number of Observations With a Response Defined as SSA-C Score ≤ 2', 'timeFrame': 'Week 2, 4, 8,12,18', 'description': 'Total number of observations with a Score of ≤ 2 on the Subject Self-Assessment on Contraction, SSA-C, using the Crow\'s Feet Wrinkle Scale, where severity is scored between 0-4 (0=absent; 4=severe). To count, a "responder" is defined as Score ≤ 2. The observation period ranges from the earliest expected onset of action at Week 2 to the likely offset of action by Week 18.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lateral Canthal Lines', "Crow's Feet"]}, 'descriptionModule': {'briefSummary': 'This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A, topical, in lateral canthal lines (LCL).', 'detailedDescription': "This product is being tested for its ability to reduce lateral canthal lines, also known as Crow's Feet."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 25 - 65 years of age\n* minimal to moderate Crow\'s Feet wrinkles at rest\n* moderate to severe Crow\'s Feet wrinkles 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 adverse reactions to any prior botulinum toxin treatments\n* history of vaccination or non-response to any prior botulinum toxin treatments\n* botulinum toxin treatment in the prior 6 months\n* present or history of neuromuscular disease, eyelid ptosis, muscle weakness, paralysis, or "dry eye"\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': 'NCT03326856', 'briefTitle': 'ET-01 in Subjects With Lateral Canthal Lines', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eirion Therapeutics Inc.'}, 'officialTitle': 'Clinical Trial to Evaluate ET-01 in Subjects With Lateral Canthal Lines', 'orgStudyIdInfo': {'id': 'ET-01-LCL-206'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'description': 'Vehicle', 'interventionNames': ['Biological: Vehicle']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 1', 'description': 'botulinum toxin, Type A, Dose 1', 'interventionNames': ['Biological: botulinum toxin, Type A']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 2', 'description': 'botulinum toxin, Type A, Dose 2', 'interventionNames': ['Biological: botulinum toxin, Type A']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 3', 'description': 'botulinum toxin, Type A, Dose 3', 'interventionNames': ['Biological: botulinum toxin, Type A']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 4', 'description': 'botulinum toxin, Type A, Dose 4', 'interventionNames': ['Biological: botulinum toxin, Type A']}], 'interventions': [{'name': 'botulinum toxin, Type A', 'type': 'BIOLOGICAL', 'otherNames': ['ET-01'], 'description': 'topical liniment', 'armGroupLabels': ['Dose 1', 'Dose 2', 'Dose 3', 'Dose 4']}, {'name': 'Vehicle', 'type': 'BIOLOGICAL', 'description': 'Vehicle Formulation', 'armGroupLabels': ['Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27519', 'city': 'Cary', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Cary Skin Care', 'geoPoint': {'lat': 35.79154, 'lon': -78.78112}}], 'overallOfficials': [{'name': 'Klaus Theobald, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eirion Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eirion Therapeutics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}