Phase 3
Completed N=306
Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines
Glabellar Frown Lines
Source: ClinicalTrials.gov NCT03014635 ↗
Enrolled (actual)
306
Serious AEs
1.0%
Results posted
Jul 2022
Primary outcomePrimary: Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales — 74.0; 1.0 percentage of responders
◆ Published Evidence
Established
76citations · ~13 / year
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).
Summary
This is a safety and efficacy study of DaxibotulinumtoxinA for Injection to treat moderate to severe frown lines.
Linked Publications (2)
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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).
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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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales |
74.0; 1.0 | — |
| SECONDARY The Time to Return to Moderate to Severe on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group |
167 | — |
| SECONDARY The Time to Return to, or Worse Than, Baseline on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group |
182 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03014635) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.