Efficacy and Safety of a New Dilution and Injection Volume of AbobotulinumtoxinA for the Treatment of Glabellar Lines
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a New Dilution and Injection Volume of AbobotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines
1 other identifier
interventional
301
1 country
11
Brief Summary
An interventional phase 3 study to evaluate efficacy and safety of a new dilution and injection volume of AbobotulinumtoxinA treatment for glabellar 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 Jun 2019
Shorter than P25 for phase_3
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2019
CompletedFirst Posted
Study publicly available on registry
May 23, 2019
CompletedStudy Start
First participant enrolled
June 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 27, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 16, 2020
CompletedResults Posted
Study results publicly available
May 11, 2021
CompletedAugust 26, 2022
May 1, 2021
3 months
May 21, 2019
April 13, 2021
August 24, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluate Composite Responder Rate at Month 1 for a Single Dose of AbobotulinumtoxinA Compared to Placebo
Composite responder is defined as a subject who achieves a score of 0 or 1 and at least 2 grades improvement on both the Investigator Live Assessment (ILA) and the Subject Self Assessment (SSA)
Month 1 after treatment
Study Arms (2)
Experimental
EXPERIMENTALAbobotulinumtoxinA
Placebo
PLACEBO COMPARATORInterventions
Treatment of glabellar facial lines with 50 U AbobotulinumtoxinA
Eligibility Criteria
You may qualify if:
- Moderate to severe glabellar lines at maximum frown
- Understands the study requirements and signs an informed consent form
You may not qualify if:
- Botulinum toxin treatment in the face within 6 months prior to study treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (11)
Galderma Study Site
Redondo Beach, California, 90277, United States
Galderma Study Site
San Diego, California, 92121, United States
Galderma Study Site
Westport, Connecticut, 06877, United States
Galderma Study Site
Washington D.C., District of Columbia, 20037, United States
Galderma Study Site
Coral Gables, Florida, 33134, United States
Galderma Study Site
Atlanta, Georgia, 30342, United States
Galderma Study Site
St Louis, Missouri, 63103, United States
Galderma Study Site
Omaha, Nebraska, 68144, United States
Galderma Study Site
Cincinnati, Ohio, 45236, United States
Galderma Study Site
Austin, Texas, 78746, United States
Galderma Study Site
Spring, Texas, 77388, United States
MeSH Terms
Interventions
Results Point of Contact
- Title
- Clinical Project Manager
- Organization
- QMedAB
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2019
First Posted
May 23, 2019
Study Start
June 17, 2019
Primary Completion
September 27, 2019
Study Completion
April 16, 2020
Last Updated
August 26, 2022
Results First Posted
May 11, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share