Trial Outcomes & Findings for Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for Treatment of Upper Facial Lines (NCT NCT04259086)

NCT ID: NCT04259086

Last Updated: 2023-06-27

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 48 participants
• Primary outcome timeframe: Week 4
• Results posted on: 2023-06-27

Participant Flow

Participant milestones

Measure	DAXI 40 U GL / 32 U FHL / 48 U LCL DaxibotulinumtoxinA for injection for the treatment of moderate to severe Glabellar Lines (GL), Forehead Lines (FHL), \& Lateral Canthal Lines (LCL) DaxibotulinumtoxinA for injection: Intramuscular injection
Overall Study STARTED	48
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	DAXI 40 U GL / 32 U FHL / 48 U LCL n=48 Participants DaxibotulinumtoxinA for injection for the treatment of moderate to severe Glabellar Lines (GL), Forehead Lines (FHL), \& Lateral Canthal Lines (LCL) DaxibotulinumtoxinA for injection: Intramuscular injection
Age, Continuous	48.9 years n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	44 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black/African American	3 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 4

Population: Evaluable population

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

Outcome measures

Measure	DAXI 40 U GL / 32 U FHL / 48 U LCL n=48 Participants DaxibotulinumtoxinA for injection for the treatment of moderate to severe Glabellar Lines (GL), Forehead Lines (FHL), \& Lateral Canthal Lines (LCL) DaxibotulinumtoxinA for injection: Intramuscular injection
Percentage of Participants With None or Mild in GL Severity at Maximum Frown	46 Participants

PRIMARY outcome

Timeframe: Week 4

Population: Evaluable population

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

Outcome measures

Measure	DAXI 40 U GL / 32 U FHL / 48 U LCL n=48 Participants DaxibotulinumtoxinA for injection for the treatment of moderate to severe Glabellar Lines (GL), Forehead Lines (FHL), \& Lateral Canthal Lines (LCL) DaxibotulinumtoxinA for injection: Intramuscular injection
Percentage of Participants With None or Mild in FHL Severity at Maximum Eyebrow Elevation	46 Participants

PRIMARY outcome

Timeframe: Week 4

Population: Evaluable population

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

Outcome measures

Measure	DAXI 40 U GL / 32 U FHL / 48 U LCL n=48 Participants DaxibotulinumtoxinA for injection for the treatment of moderate to severe Glabellar Lines (GL), Forehead Lines (FHL), \& Lateral Canthal Lines (LCL) DaxibotulinumtoxinA for injection: Intramuscular injection
Percentage of Participants With None or Mild in LCL Severity at Maximum Smile Effort	44 Participants

Adverse Events

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

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	DAXI 40 U GL / 32 U FHL / 48 U LCL n=48 participants at risk DaxibotulinumtoxinA for injection for the treatment of moderate to severe Glabellar Lines (GL), Forehead Lines (FHL), \& Lateral Canthal Lines (LCL) DaxibotulinumtoxinA for injection: Intramuscular injection
Infections and infestations COVID-19 pneumonia	2.1% 1/48 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks after treatment. The safety population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.

Other adverse events

Measure	DAXI 40 U GL / 32 U FHL / 48 U LCL n=48 participants at risk DaxibotulinumtoxinA for injection for the treatment of moderate to severe Glabellar Lines (GL), Forehead Lines (FHL), \& Lateral Canthal Lines (LCL) DaxibotulinumtoxinA for injection: Intramuscular injection
General disorders Injection site erythema	6.2% 3/48 • Number of events 7 • The adverse events were collected throughout the entire study, up to 36 weeks after treatment. The safety population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.

Additional Information

Todd Gross, PhD, VP, Clinical Development & Data Science

Revance Therapeutics, Inc.

Phone: 510-742-3400

Email: tgross@revance.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Study Center and/or Investigator shall submit to Revance a copy of the proposed publication at least sixty (60) days prior to the submission thereof for publication or disclosure to a third party: (i)to provide Revance with the opportunity to review and comment on the contents thereof, (ii)to identify any Confidential Information to be deleted from the proposed publication or disclosure, and (iii)or delay the publication or disclosure 90 days to allow Revance to pursue patent protections.
• Publication restrictions are in place

Restriction type: OTHER