Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines

Phase 3

Completed

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

• Registration Number: NCT03014622
• Lead Sponsor: Revance Therapeutics, Inc.

Brief Summary

This is a safety and efficacy study of DaxibotulinumtoxinA for Injection to treat moderate to severe frown lines.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-08
• Study First Submitted: 2016-12-22
• Study First Submitted QC: 2017-01-05
• Study First Posted: 2017-01-09
• Primary Completion: 2017-11-14
• Study Completion: 2017-11-14
• 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: 2022-06-29
• Last Update Submitted: 2022-06-29
• Results First Posted: 2022-07-21
• Last Update Posted: 2022-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 303

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: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
The Time to Return to Moderate to Severe on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group	0-36 weeks	The duration of response will be evaluated by analyzing the number of days to return to moderate or severe on both IGA-FWS and PFWS scales for DaxibotulinumtoxinA for Injection group.
The Time to Return to, or Worse Than, Baseline on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group	0-36 weeks	The duration of response will be evaluated by analyzing the number of days to return to, or worse than, baseline on both IGA-FWS and PFWS scales for DaxibotulinumtoxinA for Injection group.