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NCT Number: NCT00408785

A Study Of BOTOX For The Treatment Of Glabellar Lines

This is a Multicenter, double-blind, randomized, placebo-controlled, parallel-group comparative study to confirm the efficacy and safety of BOTOX 20 units single injection for the Chinese patients with glabellar lines. The subjects will receive a single intramuscular treatment consisting of 5 injections of either BOTOX? 20U or placebo.

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Key information

Conditions

Glabellar Lines

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female adult with Glabellar lines of at least moderate severity at maximum frown by investigator's assessment.

Exclusion criteria

  • Patients with systemic nerve conduction junction disorder or patients with infection or other skin disease/surgery at injection sites will not be eligible.
  • Patient with severe complications related to heart, kidney, liver disease or respiratory system will not be eligible.

Treatment and study plan

Botulinum Toxin Type A

Drug

botulinum toxin type A 100 units, human serum albumin 0.5 mg, sodium chloride 0.9 mg

Sodium Chloride

Drug

sodium chloride 0.9 mg

Primary outcomes

  1. The investigator's rating of Glabellar line severity at maximum frown

    Time frame: Day 30 after injection

Secondary outcomes

  1. Investigator's rating of Glabellar line severity at rest, subject's global assessment of change in appearance of glabellar lines, the subject's perception of age and safety evaluations.

    Time frame: Day 7, 30, 60, 90, 120 after injection

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of BOTOX? (Botulinum Toxin Type A) in Subjects With Glabellar Lines

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Dec 7, 2006
Registry last updated
May 31, 2017

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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