Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT06411002
Status:
COMPLETED
Last Update Posted:
2025-04-04
First Post:
2024-05-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 2a Study of DaxibotulinumtoxinA-lanm for Injection in Dynamic Forehead Lines and Glabellar Lines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-01', 'studyFirstSubmitDate': '2024-05-08', 'studyFirstSubmitQcDate': '2024-05-08', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IGA-FWS', 'timeFrame': 'Week 4', 'description': '• The proportion of subjects achieving a score of 0 (none) or 1 (mild) in GL severity at maximum contraction (maximum frown) at Week 4 as assessed by the IGA-FWS'}, {'measure': 'IGA-FHWS', 'timeFrame': 'Week 4', 'description': '• The proportion of subjects achieving a score of 0 (none) or 1 (mild) in FHL severity at maximum contraction (maximum eyebrow elevation) at Week 4 as assessed by the IGA-FHWS'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glabellar Frown Lines']}, 'descriptionModule': {'briefSummary': 'This is a Phase 2a open-label, single-arm study to evaluate the effects of DaxibotulinumtoxinA-lanm (DAXI) for Injection on the treatment of dynamic forehead lines (FHL) and glabellar lines (GL).\n\nApproximately 40 subjects (18 years of age and above) with moderate to severe GL and FHL (all assessed at maximum contraction) will be screened for eligibility with the goal of enrolling and treating 30 subjects to receive DAXI for injection after providing informed consent.\n\nThe primary objective of this study is to determine the efficacy and safety of the combined treatment of two upper facial regions with DAXI for injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Be outpatient, male or female subjects, in good general health, 18 years of age or older\n2. Have a score of moderate (2) or severe (3) GL during maximum contraction as assessed by the IGA-FWS\n3. Have a score of moderate (2) or severe (3) FHL during maximum contraction as assessed by the IGA-FHWS\n\nExclusion Criteria:\n\n1. Previous treatment with botulinum toxin type A in the face, or treatment with \\>200 U of any botulinum toxin anywhere else in the body, in the past 6 months prior to screening\n2. Pregnant, nursing, or planning a pregnancy during the study; or is a WOCBP but is not willing to use an effective method of contraception\n3. Allergy or sensitivity to any botulinum toxin preparations or to any component of the investigational product'}, 'identificationModule': {'nctId': 'NCT06411002', 'briefTitle': 'Phase 2a Study of DaxibotulinumtoxinA-lanm for Injection in Dynamic Forehead Lines and Glabellar Lines', 'organization': {'class': 'INDUSTRY', 'fullName': 'Revance Therapeutics, Inc.'}, 'officialTitle': 'A Phase 2a Study to Evaluate the Effects of DaxibotulinumtoxinA for Injection on the Treatment of Dynamic Forehead Lines and Glabellar Lines', 'orgStudyIdInfo': {'id': '2320201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Treatment (DAXXIFY)', 'description': 'All subjects will receive DAXXIFY for injection as IM injections.', 'interventionNames': ['Drug: DAXXIFY']}], 'interventions': [{'name': 'DAXXIFY', 'type': 'DRUG', 'otherNames': ['DAXI'], 'description': 'Intramuscular injection of daxibotulintoxinA-lanm', 'armGroupLabels': ['Active Treatment (DAXXIFY)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Revance', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Revance Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}