Phase 2a Study of DaxibotulinumtoxinA-lanm for Injection in Dynamic Forehead Lines and Glabellar Lines
NCT ID: NCT06411002
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
27 participants
INTERVENTIONAL
2024-04-08
2025-02-12
Brief Summary
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Approximately 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.
The 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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Active Treatment (DAXXIFY)
All subjects will receive DAXXIFY for injection as IM injections.
DAXXIFY
Intramuscular injection of daxibotulintoxinA-lanm
Interventions
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DAXXIFY
Intramuscular injection of daxibotulintoxinA-lanm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Have a score of moderate (2) or severe (3) GL during maximum contraction as assessed by the IGA-FWS
3. Have a score of moderate (2) or severe (3) FHL during maximum contraction as assessed by the IGA-FHWS
Exclusion Criteria
2. Pregnant, nursing, or planning a pregnancy during the study; or is a WOCBP but is not willing to use an effective method of contraception
3. Allergy or sensitivity to any botulinum toxin preparations or to any component of the investigational product
18 Years
ALL
No
Sponsors
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Revance Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Revance
Nashville, Tennessee, United States
Countries
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Other Identifiers
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2320201
Identifier Type: -
Identifier Source: org_study_id
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