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

Glabellar Frown Lines Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03004248
• Other study ID #: 1620303
• Status: Completed
• Phase: Phase 3
• Start date: December 9, 2016
• Est. completion date: October 17, 2018

Study information

• Verified date: June 2022
• Source: Revance Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2691
• Est. completion date: October 17, 2018
• Est. primary completion date: October 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glabellar Frown Lines

Intervention

Biological:
• Botulinum Toxins, Type A
Intramuscular Injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Revance Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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
Secondary	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