NCT04259086

Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for Treatment of Upper Facial Lines

Completed Phase 2 Results posted Last updated 27 June 2023

What this trial tests

Phase 2 trial testing DaxibotulinumtoxinA for injection in Upper Facial Lines (Glabellar Lines, Forehead Lines, & Lateral Canthal Lines) in 48 participants. Completed in 2 November 2020.

Timeline

6 December 2019

Primary endpoint
2 November 2020

2 November 2020

Quick facts

Lead sponsor	Revance Therapeutics, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	48
Start date	6 December 2019
Primary completion	2 November 2020
Estimated completion	2 November 2020
Sites	8 locations across Canada, United States

Drugs / interventions tested

• DaxibotulinumtoxinA for injection — full drug profile →

Conditions studied

• Upper Facial Lines (Glabellar Lines, Forehead Lines, & Lateral Canthal Lines) — all drugs for Upper Facial Lines (Glabellar Lines, Forehead Lines, & Lateral Canthal Lines) →

Sponsor

Revance Therapeutics, Inc. — full company profile →

Who can join

18 and older, any sex, with Upper Facial Lines (Glabellar Lines, Forehead Lines, & Lateral Canthal Lines). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With None or Mild in GL Severity at Maximum Frown Primary · Week 4

The percentage 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

Group	Value	95% CI
DAXI 40 U GL / 32 U FHL / 48 U LCL	46

Percentage of Participants With None or Mild in FHL Severity at Maximum Eyebrow Elevation Primary · Week 4

The percentage 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

Group	Value	95% CI
DAXI 40 U GL / 32 U FHL / 48 U LCL	46

Percentage of Participants With None or Mild in LCL Severity at Maximum Smile Effort Primary · Week 4

The percentage of subjects achieving a score of 0 (none) or 1 (mild) in LCL severity at maximum contraction (maximum smile effort) at Week 4 as assessed by the IGA-LCWS

Group	Value	95% CI
DAXI 40 U GL / 32 U FHL / 48 U LCL	44

Adverse events — posted to ClinicalTrials.gov

Time frame: The adverse events were collected throughout the entire study, up to 36 weeks after treatment.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

DAXI 40 U GL / 32 U FHL / 48 U LCL

Serious: 1/48 (2%)

Deaths: 0/48

Serious adverse events (1 terms)

Reaction	System	DAXI 40 U GL / 32 U FHL / …
COVID-19 pneumonia	Infections and infestations	—

Other adverse events (1 terms — click to expand)

Reaction	System	DAXI 40 U GL / 32 U FHL / …
Injection site erythema	General disorders	—

Most-reported serious reactions: COVID-19 pneumonia.

Data from ClinicalTrials.gov NCT04259086 adverse events section.

Sponsor's own description

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)

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Treatment of Upper Facial Lines With DaxibotulinumtoxinA for Injection: Results From an Open-Label Phase 2 Study.
   Dover JS, Humphrey SD, Lorenc ZP, Shamban A, et al · · 2023 · cited 2× · PMID 36533798 · DOI 10.1097/dss.0000000000003637