NCT03736928

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 401 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

An interventional phase 2 study to evaluate safety and efficacy of AbobotulinumtoxinA treatment for glabellar lines

Conditions

• Glabellar Frown Lines

Interventions

Type	Name	Description
BIOLOGICAL	AbobotulinumtoxinA dose level 1 or 2	Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
OTHER	placebo	Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
BIOLOGICAL	AbobotulinumtoxinA dose 3	Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
BIOLOGICAL	AbobotulinumtoxinA dose 4	Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines

Timeline

• Start date: 2018-11-26
• Primary completion: 2019-12-09
• Completion: 2020-08-20
• First posted: 2018-11-09
• Last updated: 2022-08-26
• Results posted: 2021-02-11

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study