Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Glabellar Lines
A Multicenter, Randomized, Dose-Ranging, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines
1 other identifier
interventional
401
1 country
10
Brief Summary
An interventional phase 2 study to evaluate safety and efficacy 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 P75+ for phase_2
Started Nov 2018
10 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
November 7, 2018
CompletedFirst Posted
Study publicly available on registry
November 9, 2018
CompletedStudy Start
First participant enrolled
November 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 9, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2020
CompletedResults Posted
Study results publicly available
February 11, 2021
CompletedAugust 26, 2022
January 1, 2021
1 year
November 7, 2018
December 21, 2020
August 24, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Composite Responders at Month 1
composite responder is defined as a subject who achieves a score of 0 or 1 and at least 2 grade improvement on both the Investigator Live Assessment (ILA) and the Subject Self Assessment (SSA)
Month 1 after treatment
Study Arms (4)
Placebo
PLACEBO COMPARATORIntramuscular single treatment
AbobotulinumtoxinA dose level 1 or 2
EXPERIMENTALIntramuscular single treatment
AbobotulinumtoxinA dose level 3
EXPERIMENTALIntramuscular single treatment
AbobotulinumtoxinA dose level 4
EXPERIMENTALIntramuscular single treatment
Interventions
Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
Eligibility Criteria
You may qualify if:
- Moderate to severe glabellar lines at maximum frown as assessed by the Investigator using a photographic scale
- Moderate to severe glabellar lines at maximum frown as assessed by the subject using a static categorical scale
You may not qualify if:
- Botulinum toxin treatment in the face within 9 months prior to study treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (10)
Galderma Research Site
Encino, California, 91436, United States
Galderma Research Site
Manhattan Beach, California, 90266, United States
Galderma Research Site
Vista, California, 92083, United States
Galderma Research Site
Coral Gables, Florida, 33146, United States
Galderma Research Site
Chicago, Illinois, 60611, United States
Galderma Research Site
New Orleans, Louisiana, 70130, United States
Galderma Research Site
New York, New York, 10028, United States
Galderma Research Site
Chapel Hill, North Carolina, 27517, United States
Galderma Research Site
Charlotte, North Carolina, 28207, United States
Galderma Research Site
Mequon, Wisconsin, 53092, United States
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 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2018
First Posted
November 9, 2018
Study Start
November 26, 2018
Primary Completion
December 9, 2019
Study Completion
August 20, 2020
Last Updated
August 26, 2022
Results First Posted
February 11, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share