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

An Open-Label, Multi-Center Trial to Assess the Safety of Single and Repeat Treatments of DaxibotulinumtoxinA for Injection for Treatment of Moderate to Severe Glabellar Lines (SAKURA OPEN-LABEL SAFETY)

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.

Study Overview

• Status: Completed
• Conditions: Glabellar Frown Lines
• Intervention / Treatment: Biological: Botulinum Toxins, Type A

• Study Type: Interventional
• Enrollment (Actual): 2691
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E1
  • Ontario
    • Burlington, Ontario, Canada, L7N 3N2
    • Toronto, Ontario, Canada, M5R3N8
    • Woodbridge, Ontario, Canada, L4L 8E2
  • Quebec
    • Montréal, Quebec, Canada, H3Z 1BZ
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
  • California
    • Beverly Hills, California, United States, 90210
    • Encinitas, California, United States, 92024
    • Fremont, California, United States, 94538
    • Los Angeles, California, United States, 90069
    • Manhattan Beach, California, United States, 90266
    • Newport Beach, California, United States, 92663
    • Roseville, California, United States, 95661
    • Sacramento, California, United States, 95819
    • San Diego, California, United States, 92121
    • San Diego, California, United States, 92122
    • San Francisco, California, United States, 94117
    • Santa Monica, California, United States, 90404
  • Colorado
    • Greenwood Village, Colorado, United States, 80111
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
    • Washington, District of Columbia, United States, 20037
  • Florida
    • Boca Raton, Florida, United States, 33431
    • Bradenton, Florida, United States, 34209
    • Coral Gables, Florida, United States, 33146
    • Miami, Florida, United States, 33137
    • West Palm Beach, Florida, United States, 33401
  • Illinois
    • Chicago, Illinois, United States, 60611
    • Lincolnshire, Illinois, United States, 60069
    • Naperville, Illinois, United States, 60563
  • Louisiana
    • New Orleans, Louisiana, United States, 70124
    • New Orleans, Louisiana, United States, 70130
  • Maryland
    • Baltimore, Maryland, United States, 21208
    • Glenn Dale, Maryland, United States, 20769
    • Hunt Valley, Maryland, United States, 21030
    • Rockville, Maryland, United States, 20850
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 27517
  • Michigan
    • Birmingham, Michigan, United States, 48009
  • Minnesota
    • Fridley, Minnesota, United States, 55432
  • Missouri
    • Saint Louis, Missouri, United States, 63122
  • Nebraska
    • Omaha, Nebraska, United States, 68144
  • New Jersey
    • Montclair, New Jersey, United States, 07042
  • New York
    • New York, New York, United States, 10016
    • New York, New York, United States, 10011
    • New York, New York, United States, 10022
    • New York, New York, United States, 10029
    • New York, New York, United States, 10028
    • New York, New York, United States, 10075
    • West Islip, New York, United States, 11795
    • White Plains, New York, United States, 10604
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27517
    • Charlotte, North Carolina, United States, 28207
    • High Point, North Carolina, United States, 27262
  • Oregon
    • Portland, Oregon, United States, 97223
  • Pennsylvania
    • Drexel Hill, Pennsylvania, United States, 19026
  • Tennessee
    • Nashville, Tennessee, United States, 37203
    • Nashville, Tennessee, United States, 37215
  • Texas
    • Austin, Texas, United States, 78746
    • College Station, Texas, United States, 77845
    • Houston, Texas, United States, 77056
    • Katy, Texas, United States, 77494
  • Wisconsin
    • Mequon, Wisconsin, United States, 53092

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DaxibotulinumtoxinA 40 units; Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection	Biological: Botulinum Toxins, Type A; Intramuscular Injection; Other Names: DaxibotulinumtoxinA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment Emergent Adverse Events (TEAE)	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.	0-36 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales	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	Week 4
The Time to Return to Moderate to Severe on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group	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.	0-36 weeks per cycles 1 and 2
The Time to Return to, or Worse Than, Baseline on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group	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.	0-36 weeks per Cycle 1 and 2

Collaborators and Investigators

• Sponsor: Revance Therapeutics, Inc.

Publications and helpful links

General Publications

• Green JB, Mariwalla K, Coleman K, Ablon G, Weinkle SH, Gallagher CJ, Vitarella D, Rubio RG. A Large, Open-Label, Phase 3 Safety Study of DaxibotulinumtoxinA for Injection in Glabellar Lines: A Focus on Safety From the SAKURA 3 Study. Dermatol Surg. 2021 Jan 1;47(1):42-46. doi: 10.1097/DSS.0000000000002463.
• Fabi SG, Cohen JL, Green LJ, Dhawan S, Kontis TC, Baumann L, Gross TM, Gallagher CJ, Brown J, Rubio RG. DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Efficacy Results From SAKURA 3, a Large, Open-Label, Phase 3 Safety Study. Dermatol Surg. 2021 Jan 1;47(1):48-54. doi: 10.1097/DSS.0000000000002531.

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2016
• Primary Completion (Actual): October 17, 2018
• Study Completion (Actual): October 17, 2018

Study Registration Dates

• First Submitted: December 22, 2016
• First Submitted That Met QC Criteria: December 22, 2016
• First Posted (Estimate): December 28, 2016

Study Record Updates

• Last Update Posted (Actual): July 13, 2022
• Last Update Submitted That Met QC Criteria: June 16, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: glabellar lines, frown lines
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: 1620303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO