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)
1 other identifier
interventional
2,691
2 countries
61
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2016
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 9, 2016
CompletedFirst Submitted
Initial submission to the registry
December 22, 2016
CompletedFirst Posted
Study publicly available on registry
December 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 17, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 17, 2018
CompletedResults Posted
Study results publicly available
July 13, 2022
CompletedJuly 13, 2022
June 1, 2022
1.9 years
December 22, 2016
February 15, 2022
June 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales
Week 4
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, or Worse Than, Baseline on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group
0-36 weeks per Cycle 1 and 2
Study Arms (1)
DaxibotulinumtoxinA 40 units
EXPERIMENTALBiological/Vaccine: Botulinum Toxins, Type A Intramuscular injection
Interventions
Intramuscular Injection
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (61)
Unknown Facility
Birmingham, Alabama, 35205, United States
Unknown Facility
Beverly Hills, California, 90210, United States
Unknown Facility
Encinitas, California, 92024, United States
Unknown Facility
Fremont, California, 94538, United States
Unknown Facility
Los Angeles, California, 90069, United States
Unknown Facility
Manhattan Beach, California, 90266, United States
Unknown Facility
Newport Beach, California, 92663, United States
Unknown Facility
Roseville, California, 95661, United States
Unknown Facility
Sacramento, California, 95819, United States
Unknown Facility
San Diego, California, 92121, United States
Unknown Facility
San Diego, California, 92122, United States
Unknown Facility
San Francisco, California, 94117, United States
Unknown Facility
Santa Monica, California, 90404, United States
Unknown Facility
Greenwood Village, Colorado, 80111, United States
Unknown Facility
Washington D.C., District of Columbia, 20007, United States
Unknown Facility
Washington D.C., District of Columbia, 20037, United States
Unknown Facility
Boca Raton, Florida, 33431, United States
Unknown Facility
Bradenton, Florida, 34209, United States
Unknown Facility
Coral Gables, Florida, 33146, United States
Unknown Facility
Miami, Florida, 33137, United States
Unknown Facility
West Palm Beach, Florida, 33401, United States
Unknown Facility
Chicago, Illinois, 60611, United States
Unknown Facility
Lincolnshire, Illinois, 60069, United States
Unknown Facility
Naperville, Illinois, 60563, United States
Unknown Facility
New Orleans, Louisiana, 70124, United States
Unknown Facility
New Orleans, Louisiana, 70130, United States
Unknown Facility
Baltimore, Maryland, 21208, United States
Unknown Facility
Glenn Dale, Maryland, 20769, United States
Unknown Facility
Hunt Valley, Maryland, 21030, United States
Unknown Facility
Rockville, Maryland, 20850, United States
Unknown Facility
Chestnut Hill, Massachusetts, 27517, United States
Unknown Facility
Birmingham, Michigan, 48009, United States
Unknown Facility
Fridley, Minnesota, 55432, United States
Unknown Facility
St Louis, Missouri, 63122, United States
Unknown Facility
Omaha, Nebraska, 68144, United States
Unknown Facility
Montclair, New Jersey, 07042, United States
Unknown Facility
New York, New York, 10011, United States
Unknown Facility
New York, New York, 10016, United States
Unknown Facility
New York, New York, 10022, United States
Unknown Facility
New York, New York, 10028, United States
Unknown Facility
New York, New York, 10029, United States
Unknown Facility
New York, New York, 10075, United States
Unknown Facility
West Islip, New York, 11795, United States
Unknown Facility
White Plains, New York, 10604, United States
Unknown Facility
Chapel Hill, North Carolina, 27517, United States
Unknown Facility
Charlotte, North Carolina, 28207, United States
Unknown Facility
High Point, North Carolina, 27262, United States
Unknown Facility
Portland, Oregon, 97223, United States
Unknown Facility
Drexel Hill, Pennsylvania, 19026, United States
Unknown Facility
Nashville, Tennessee, 37203, United States
Unknown Facility
Nashville, Tennessee, 37215, United States
Unknown Facility
Austin, Texas, 78746, United States
Unknown Facility
College Station, Texas, 77845, United States
Unknown Facility
Houston, Texas, 77056, United States
Unknown Facility
Katy, Texas, 77494, United States
Unknown Facility
Mequon, Wisconsin, 53092, United States
Unknown Facility
Vancouver, British Columbia, V5Z 4E1, Canada
Unknown Facility
Burlington, Ontario, L7N 3N2, Canada
Unknown Facility
Toronto, Ontario, M5R3N8, Canada
Unknown Facility
Woodbridge, Ontario, L4L 8E2, Canada
Unknown Facility
Montreal, Quebec, H3Z 1BZ, Canada
Related Publications (2)
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.
PMID: 32773447DERIVEDFabi 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.
PMID: 32773446DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Todd Gross, PhD, VP Data Science, Interim Head of Clinical Development
- Organization
- Revance Therapeutics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2016
First Posted
December 28, 2016
Study Start
December 9, 2016
Primary Completion
October 17, 2018
Study Completion
October 17, 2018
Last Updated
July 13, 2022
Results First Posted
July 13, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share