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OpenTrials
Completed

NCT Number: NCT03960957

Efficacy and Safety of a New Dilution and Injection Volume of AbobotulinumtoxinA for the Treatment of Glabellar Lines

An interventional phase 3 study to evaluate efficacy and safety of a new dilution and injection volume of AbobotulinumtoxinA treatment for glabellar lines

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Key information

Conditions

Glabellar Frown Lines

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Galderma Study Site, Redondo Beach, 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
  • Understands the study requirements and signs an informed consent form

Exclusion criteria

  • Botulinum toxin treatment in the face within 6 months prior to study treatment

Treatment and study plan

AbobotulinumtoxinA

Biological

Treatment of glabellar facial lines with 50 U AbobotulinumtoxinA

Placebo

Other

Treatment of glabellar facial lines with placebo

Primary outcomes

  1. Evaluate Composite Responder Rate at Month 1 for a Single Dose of AbobotulinumtoxinA Compared to Placebo

    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 grades 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, 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
May 23, 2019
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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