Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines
A Phase 3, Randomized, Double-Blind, Placebo Controlled, Multi-Center Trial to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines (SAKURA-1)
1 other identifier
interventional
303
1 country
15
Brief Summary
This is a safety and efficacy study of DaxibotulinumtoxinA for Injection to treat moderate to severe frown lines.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2016
Shorter than P25 for phase_3
15 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 8, 2016
CompletedFirst Submitted
Initial submission to the registry
December 22, 2016
CompletedFirst Posted
Study publicly available on registry
January 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 14, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 14, 2017
CompletedResults Posted
Study results publicly available
July 21, 2022
CompletedJuly 21, 2022
June 1, 2022
11 months
December 22, 2016
February 15, 2022
June 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
The Time to Return to Moderate to Severe on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group
0-36 weeks
The Time to Return to, or Worse Than, Baseline on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group
0-36 weeks
Study Arms (2)
DaxibotulinumtoxinA 40 units
EXPERIMENTALBiological/Vaccine: Botulinum Toxins, Type A Intramuscular injection
Placebo
PLACEBO COMPARATORBiological/Vaccine: Placebos 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 (15)
Unknown Facility
Birmingham, Alabama, 35205, United States
Unknown Facility
Beverly Hills, California, 90210, United States
Unknown Facility
Newport Beach, California, 92663, United States
Unknown Facility
San Francisco, California, 94117, United States
Unknown Facility
Santa Monica, California, 90404, United States
Unknown Facility
Greenwood, Colorado, 80111, United States
Unknown Facility
Boca Raton, Florida, 33431, United States
Unknown Facility
Coral Gables, Florida, 33146, United States
Unknown Facility
Chestnut Hill, Massachusetts, 02467, United States
Unknown Facility
Birmingham, Michigan, 48009, United States
Unknown Facility
Montclair, New Jersey, 07042, United States
Unknown Facility
New York, New York, 10001, United States
Unknown Facility
New York, New York, 10022, United States
Unknown Facility
Chapel Hill, North Carolina, 27517, United States
Unknown Facility
Nashville, Tennessee, 37203, United States
Related Publications (2)
Bertucci V, Solish N, Kaufman-Janette J, Yoelin S, Shamban A, Schlessinger J, Snyder D, Gallagher C, Liu Y, Shears G, Rubio RG. DaxibotulinumtoxinA for Injection has a prolonged duration of response in the treatment of glabellar lines: Pooled data from two multicenter, randomized, double-blind, placebo-controlled, phase 3 studies (SAKURA 1 and SAKURA 2). J Am Acad Dermatol. 2020 Apr;82(4):838-845. doi: 10.1016/j.jaad.2019.06.1313. Epub 2019 Nov 29.
PMID: 31791824DERIVEDCarruthers JD, Fagien S, Joseph JH, Humphrey SD, Biesman BS, Gallagher CJ, Liu Y, Rubio RG; SAKURA 1 and SAKURA 2 Investigator Group; SAKURA 1 and SAKURA 2 Investigator Group includes the following. DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Results from Each of Two Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Studies (SAKURA 1 and SAKURA 2). Plast Reconstr Surg. 2020 Jan;145(1):45-58. doi: 10.1097/PRS.0000000000006327.
PMID: 31609882DERIVED
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
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2016
First Posted
January 9, 2017
Study Start
December 8, 2016
Primary Completion
November 14, 2017
Study Completion
November 14, 2017
Last Updated
July 21, 2022
Results First Posted
July 21, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share