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Neurotoxin

DAXI 40 U GL / 32 U FHL / 48 U LCL for Facial Wrinkles

Phase 2
Waitlist Available
Research Sponsored by Revance Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening - week 36
Awards & highlights
No Placebo-Only Group

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)

Eligible Conditions
  • Facial Wrinkles

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening - week 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening - week 36 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants With None or Mild in FHL Severity at Maximum Eyebrow Elevation
Percentage of Participants With None or Mild in GL Severity at Maximum Frown
Percentage of Participants With None or Mild in LCL Severity at Maximum Smile Effort
Other study objectives
Incidence, severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) during the overall study duration. [ Time Frame: Screening - Week 36 ]

Side effects data

From 2020 Phase 2 trial • 48 Patients • NCT04259086
6%
Injection site erythema
2%
COVID-19 pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
DAXI 40 U GL / 32 U FHL / 48 U LCL

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: DAXI 40 U GL / 32 U FHL / 48 U LCLExperimental Treatment1 Intervention
DaxibotulinumtoxinA for injection for the treatment of moderate to severe Glabellar Lines (GL), Forehead Lines (FHL), \& Lateral Canthal Lines (LCL)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DaxibotulinumtoxinA for injection
2019
Completed Phase 3
~480

Find a Location

Who is running the clinical trial?

Revance Therapeutics, Inc.Lead Sponsor
30 Previous Clinical Trials
6,497 Total Patients Enrolled
Dom VitarellaStudy DirectorRevance Therapeutics, Inc.
1 Previous Clinical Trials
63 Total Patients Enrolled
~8 spots leftby Nov 2025
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