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Neurotoxin

DAXXIFY for Frown Lines

Phase 2
Recruiting
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
Must not have
Allergy or sensitivity to any botulinum toxin preparations or to any component of the investigational product
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4
Awards & highlights
No Placebo-Only Group

Summary

This trial will test the effectiveness and safety of a treatment called DAXI for Injection on dynamic forehead lines and glabellar lines. They will enroll 30 subjects with moderate to severe lines in these

Who is the study for?
This trial is for adults over 18 with moderate to severe frown lines and forehead wrinkles, visible at maximum contraction. Participants should be in good general health and able to visit the clinic as outpatients.
What is being tested?
The study tests DaxibotulinumtoxinA-lanm (DAXI) injections on two facial areas: the forehead and between the eyebrows. It's an open-label, single-arm Phase 2a trial aiming to enroll about 30 subjects to assess efficacy and safety.
What are the potential side effects?
While specific side effects are not listed here, similar treatments often include temporary bruising or swelling at injection sites, headache, muscle weakness near treated areas, or flu-like symptoms.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am allergic to botulinum toxin or its ingredients.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
IGA-FHWS
IGA-FWS

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: Active Treatment (DAXXIFY)Experimental Treatment1 Intervention
All subjects will receive DAXXIFY for injection as IM injections.

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Who is running the clinical trial?

Revance Therapeutics, Inc.Lead Sponsor
30 Previous Clinical Trials
6,515 Total Patients Enrolled
1 Trials studying Frown Lines
61 Patients Enrolled for Frown Lines
~15 spots leftby May 2025
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