AbobotulinumtoxinA dose level 1 or 2
BiologicalIntramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
Completed
NCT Number: NCT03736928
Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Glabellar Lines
An interventional phase 2 study to evaluate safety and efficacy of AbobotulinumtoxinA treatment for glabellar lines
Completed
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Notify MeKey information
Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Galderma Research Site, Encino, California, United States
Loading trial locations.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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
Exclusion criteria
- Botulinum toxin treatment in the face within 9 months prior to study treatment
Treatment and study plan
Placebo
OtherIntramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
AbobotulinumtoxinA dose 3
BiologicalIntramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
AbobotulinumtoxinA dose 4
BiologicalIntramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
Primary outcomes
-
Number of Composite Responders at Month 1
Time frame: Month 1 after treatment
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)
Sponsors and collaborators
Lead sponsor
Galderma R&D
Industry
Registry information
Official study title
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
Important dates
- Study start
- 2018
- Primary completion
- 2019
- Study completion
- 2020
- First posted
- Nov 9, 2018
- Registry last updated
- Aug 26, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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