Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-04-05 @ 12:13 PM
Study NCT ID:
NCT07321834
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-01-07
First Post:
2026-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate AI-09 In Participants With Glabellar Lines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double Blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-05', 'studyFirstSubmitDate': '2026-01-02', 'studyFirstSubmitQcDate': '2026-01-05', 'lastUpdatePostDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IGA-C', 'timeFrame': 'From enrollment (baseline) to the Week 04 Visit', 'description': 'Change from Baseline (CfB) in IGA-C (Investigator Global Assessment on Contraction) as assessed using the 4-point Glabellar Line Severity Scale (GLS), with score "3" being Severe and score "0" being None.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Botulinum Toxin', 'Ready to use', 'Glabellar Lines', 'AI-09-GL-201'], 'conditions': ['Glabellar Lines']}, 'descriptionModule': {'briefSummary': 'Phase 2 clinical study to evaluate the efficacy, safety, and tolerability of AI-09, a Ready-to-Use Liquid Injectable Botulinum Toxin.', 'detailedDescription': 'This is a Phase 2, multicenter, out-patient, prospectively randomized, double-blind, vehicle-controlled, multi-center clinical study to evaluate the efficacy, safety, and tolerability of AI-09, a Ready-to-Use Liquid Injectable Botulinum Toxin, administered to participants with glabellar lines. The study is designed as a single dose study evaluating AI-09 at a dose of versus Vehicle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20 to 70 years of age\n* moderate to severe glabellar lines (IGA 2 to 3) at maximum frown\n* moderate to severe glabellar lines (SSA 2 to 3) at maximum frown\n* willingness to refrain from the use of facial fillers, retinoids, Botox®, laser\n* female participants of child-bearing potential must have a negative urine pregnancy test and be non-lactating at the Baseline (Day 0) visit and must utilize birth control throughout the study\n* participants should be in good general health as determined by the investigator and free of any disease that may interfere with study evaluations or the Investigational Product\n\nExclusion Criteria:\n\n* the inability to substantially lessen glabellar lines by physically spreading them apart\n* eyelid ptosis, and/ or excessive weakness or atrophy in the target muscle(s)\n* presence or history of "dry eye"\n* history of periocular surgery, brow lift or related procedures, or deep dermal scarring\n* concurrent or recent (within the last 6 months) use of any other botulinum toxin drug product anywhere in the body\n* history of immunization or hypersensitivity to any botulinum toxin serotype\n* history of non-response to any prior botulinum toxin treatments anticipated need for treatment with botulinum toxin of any serotype for any reason during the trial (other than the investigational treatment)\n* any medical condition that may put the subject at increased risk with exposure to botulinum toxin including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function\n* pregnancy or lactation\n* application of any topical prescription medication to the treatment area within 14 days prior to treatment\n* participation in another investigational drug trial or receiving any investigational treatment(s) within 30 days of Baseline (Day 0)\n* alcohol or drug abuse within the past 3 years\n* refusal or inability with the subject\'s ability to give informed consent or comply with the requirements of the protocol for any reason'}, 'identificationModule': {'nctId': 'NCT07321834', 'briefTitle': 'A Study to Evaluate AI-09 In Participants With Glabellar Lines', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eirion Therapeutics Inc.'}, 'officialTitle': 'A Phase 2, Randomized, Double-blind, Vehicle-Controlled, Multi-Center Clinical Trial Study to Evaluate Ready to Use Injectable AI-09 In Participants With Glabellar Lines', 'orgStudyIdInfo': {'id': 'AI-09-GL-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Treatment', 'description': 'AI-09', 'interventionNames': ['Biological: AI-09 Ready Use Injectable Botulinum Toxin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'description': 'Vehicle', 'interventionNames': ['Biological: Vehicle']}], 'interventions': [{'name': 'AI-09 Ready Use Injectable Botulinum Toxin', 'type': 'BIOLOGICAL', 'description': 'AI-09 Ready Use Injectable Botulinum Toxin', 'armGroupLabels': ['Active Treatment']}, {'name': 'Vehicle', 'type': 'BIOLOGICAL', 'description': 'Vehicle', 'armGroupLabels': ['Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'Center for Clinical and Cosmetic Research', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Institute of the Southeast, Inc.', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '70115', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Delricht Research', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '37215', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Clinical Research Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Your Health', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eirion Therapeutics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}