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OpenTrials
Completed

NCT Number: NCT02236312

Safety and Efficacy Study of Botulinum Toxin for the Treatment of Glabellar Frown Lines

The primary objective of the study is to evaluate the efficacy in wrinkle reduction of a single treatment of three different doses of botulinum toxin compared to placebo, in the treatment of moderate to very severe glabellar frown lines.

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Key information

Conditions

Glabellar Frown Lines

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Private practice, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Moderate to Very Severe glabellar lines at maximum frown as assessed by the subject and the Investigator and at least Mild glabellar lines at rest

Exclusion criteria

  • Any previous treatment with any botulinum toxin
  • Rhytids of the glabellar region that cannot be smoothed out by manually spreading the skin apart
  • Any previous insertion of any permanent or semi-permanent material, hyaluronic acid or collagen fillers to the glabellar region
  • Any history of facial surgery above the lower orbital rim
  • Any planned facial surgery or aesthetic procedure during the study period
  • Ablative skin resurfacing or chemical peels above the lower orbital rim in the previous 12 months or during the study period

Treatment and study plan

Botulinum Toxin Type A

Drug

Placebo

Drug

Primary outcomes

  1. Reduction of glabellar frown line severity on Day 14 following treatment with botulinum toxin

    Time frame: 14 Days

    Reduction in glabellar frown line severity is derived separately for the Investigator and the subject assessment, using a validated photo scale, at maximum frown on Day 14.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

A Multicentre, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Three Doses of Botulinum Toxin in the Treatment of Moderate to Very Severe Glabellar Frown Lines

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Sep 10, 2014
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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