Phase 2
N=48
Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for Treatment of Upper Facial Lines
Upper Facial Lines (Glabellar Lines, Forehead Lines, & Lateral Canthal Lines)
Bottom Line
View on ClinicalTrials.gov: NCT04259086 ↗Enrolled (actual)
48
Serious AEs
2.1%
Results posted
Jun 2023
Primary outcome: Primary: Percentage of Participants With None or Mild in GL Severity at Maximum Frown — 46 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- DaxibotulinumtoxinA for injection (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Revance Therapeutics, Inc.
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With None or Mild in GL Severity at Maximum Frown |
46 | — |
| PRIMARY Percentage of Participants With None or Mild in FHL Severity at Maximum Eyebrow Elevation |
46 | — |
| PRIMARY Percentage of Participants With None or Mild in LCL Severity at Maximum Smile Effort |
44 | — |
Summary
This is a Phase 2, multicenter, open-label, single-arm study to evaluate the efficacy and safety of DaxibotulinumtoxinA for injection (DAXI for injection) in the treatment of Glabellar Lines (GL), Dynamic Forehead Lines (FHL), and Lateral Canthal Lines(LCL)
Eligibility Criteria
Inclusion Criteria
- Provide written informed consent consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines and local laws, including authorization to release health information, signed prior to any study procedures being performed
- Be outpatient, male or female subjects, in good general health, 18 years of age or older
- Have a score of moderate (2) or severe (3) Glabellar Lines during maximum contraction as assessed by the Investigator Global Assessment-Frown Wrinkle Severity (IGA-FWS) and Patient Frown Wrinkle Severity (PFWS)
- Have a score of moderate (2) or severe (3) Forehead Lines during maximum contraction as assessed by the Investigator Global Assessment Forehead Wrinkle Severity (IGA-FHWS) and Patient Forehead Wrinkle Severity (PFHWS)
- Have a score of moderate (2) or severe (3) Lateral Canthal Lines at maximum contraction as assessed by the Investigator Global Assessment of Lateral Canthal Wrinkle Severity (IGA-LCWS) and Patient Lateral Canthal Wrinkle Severity (PLCWS) (scores must be consistent bilaterally for each scale considered separately)
- Able to understand the requirements of the study and be willing and able to follow all study procedures, attend all scheduled visits, comprehend and complete the questionnaires without outside assistance and successfully complete the study
Exclusion Criteria
- Active skin disease, infections, or inflammation at the injection sites
- Planned or anticipated need for surgery or hospitalization through the end of the study
- Pregnant, nursing, or planning a pregnancy during the study; or is a Women of Child Bearing Potential (WOCBP) but is not willing to use an effective method of contraception
- Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to screening
Data sourced from ClinicalTrials.gov (NCT04259086). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.