CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,691 enrolled
Drug / intervention
Botulinum Toxins, Type Abiological
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Moderate (2) or severe (3) glabellar lines on maximum frown per Investigator Global Assessment Frown Wrinkle Severity (IGA-FWS) scale
  • ✓Moderate (2) or severe (3) glabellar lines on maximum frown per Patient Frown Wrinkle Severity (PFWS) scale
  • ✓Willing and able to follow all trial procedures, attend all scheduled visits, and complete the trial
Key exclusion· 5
  • ✕Neurological conditions placing subject at increased risk with botulinum toxin exposure, including amyotrophic lateral sclerosis, motor neuropathy, Lambert-Eaton syndrome, and myasthenia gravis
  • ✕Active skin disease, infections, or inflammation at injection sites
  • ✕Plan to receive botulinum toxin type A in the face during the study
  • ✕History of allergy or sensitivity to botulinum toxin preparations or any component of the test article

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03004248
NCT03004248Phase 3Completed
CompareCT.gov

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)

Revance Therapeutics, Inc.·interventional·Posted Dec 28, 2016·Updated Jul 13, 2022

In Brief

A Phase 3 clinical trial evaluating Botulinum Toxins, Type A for Glabellar Frown Lines. Completed, enrolled 2,691 participants across 61 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlabellar Frown Lines
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 28, 2016
Enrollment StartDec 9, 2016
Primary CompletionOct 17, 2018
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 9.5 years ago

Interventions

Botulinum Toxins, Type Abiological

Intramuscular Injection