Safety of Single and Repeat Treatments of DaxibotulinumtoxinA for Injection for Treatment of Moderate to Severe Glabellar Lines

Phase 3

Completed

• Conditions: Glabellar Frown Lines
• Interventions: Biological: Botulinum Toxins, Type A

• Registration Number: NCT03004248
• Lead Sponsor: Revance Therapeutics, Inc.

Brief Summary

This is a long term safety study of DaxibotulinumtoxinA for Injection for the treatment of moderate to severe glabellar lines following single and repeat administration.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-09
• Study First Submitted: 2016-12-22
• Study First Submitted QC: 2016-12-22
• Study First Posted: 2016-12-28
• Primary Completion: 2018-10-17
• Study Completion: 2018-10-17
• Disposition First Submitted: 2019-09-13
• Disposition First Submitted QC: 2019-09-20
• Disposition First Posted: 2019-10-04
• Results First Submitted: 2022-02-15
• Status Verified: 2022-06
• Results First Submitted QC: 2022-06-16
• Last Update Submitted: 2022-06-16
• Results First Posted: 2022-07-13
• Last Update Posted: 2022-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2691

Inclusion Criteria

• Provide written informed consent including authorization to release health information
• Moderate (2) or severe (3) glabellar lines during maximum frown based on the Investigator Global Assessment Frown Wrinkle Severity (IGA-FWS) scale
• Moderate (2) or severe (3) glabellar lines during maximum frown based on the Patient Frown Wrinkle Severity (PFWS) scale
• Willing and able to follow all trial procedures, attend all scheduled visits, and successfully complete the trial

Exclusion Criteria

• Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis
• Active skin disease, infections or inflammation at the injection sites
• Plan to receive botulinum toxin type A anywhere in the face through the duration of the study
• History of allergy or sensitivity to any botulinum toxin preparations or to any component of the test article
• Current enrollment in an investigational drug or device trial or participation in such a trial within the last 30 days prior to screening through end of trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DaxibotulinumtoxinA 40 units	Botulinum Toxins, Type A	Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment Emergent Adverse Events (TEAE)	0-36 weeks	Incidence rates based on the number and percentage of subjects treated within each cycle who report Adverse Events (AEs) at anytime following study treatment. Note that subjects could receive up to 3 consecutive treatments during the 36-week follow up period.

Secondary Outcome Measures

Name	Time	Method
The Time to Return to, or Worse Than, Baseline on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group	0-36 weeks per Cycle 1 and 2	The time to return to or worse than baseline on both FWS scales was measured following treatment cycles 1 and 2. Because subjects were only followed for 12 weeks following treatment cycle 3, time to return was not analyzed in this cycle.
Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales	Week 4	Percentage of subjects who achieve at least a 2-point improvement from baseline and a score of 0 or 1 (i.e. none or mild wrinkles in severity) on both Investigator and Subject Frown Wrinkle Severity (FWS) assessments
The Time to Return to Moderate to Severe on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group	0-36 weeks per cycles 1 and 2	The time to return to moderate to severe on both scales was measured following treatment cycles 1 and 2. Because subjects were only followed for 12 weeks following treatment cycle 3, time to return was not analyzed for this cycle.