Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 720 for:    Botulinum Toxins, Type A

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03004248
Recruitment Status : Completed
First Posted : December 28, 2016
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
Revance Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Glabellar Frown Lines Biological: Botulinum Toxins, Type A Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2691 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 9, 2016
Actual Primary Completion Date : October 17, 2018
Actual Study Completion Date : October 17, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: DaxibotulinumtoxinA 40 units
Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection
Biological: Botulinum Toxins, Type A
Intramuscular Injection
Other Name: DaxibotulinumtoxinA




Primary Outcome Measures :
  1. Incidence, severity and relationship to trial drug of treatment-emergent adverse events and serious adverse events during each treatment and the trial overall [ Time Frame: 84 weeks ]

Secondary Outcome Measures :
  1. Proportion of subjects with a ≥1 point improvement on GAIS at each visit over time [ Time Frame: 36 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03004248


  Show 61 Study Locations
Sponsors and Collaborators
Revance Therapeutics, Inc.

Layout table for additonal information
Responsible Party: Revance Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03004248     History of Changes
Other Study ID Numbers: 1620303
First Posted: December 28, 2016    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Revance Therapeutics, Inc.:
glabellar lines, frown lines

Additional relevant MeSH terms:
Layout table for MeSH terms
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents