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NCT Number: NCT00430963

IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines

IncobotulinumtoxinA (Xeomin) is a botulinum toxin type A preparation free of complexing proteins, i.e. free of proteins other than the active toxin. Injected into the muscle, IncobotulinumtoxinA (Xeomin) causes local weakening. Botulinum toxin type A is widely used for aesthetic treatment of facial lines. This study investigated the efficacy and safety of IncobotulinumtoxinA (Xeomin) in the treatment of glabellar frown lines compared to placebo. The study consisted of a Main Period and an Open-Label Extension [OLEX] Period of 120 days each.

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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 3

Primary location

Merz Pharmaceuticals GmbH

Frankfurt, 60318, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

•Moderate to severe glabellar frown lines

Exclusion criteria

  • Previous insertion of permanent material in the glabellar area
  • Neuromuscular function disease

Treatment and study plan

IncobotulinumtoxinA (Xeomin) (20 Units)

Drug

Placebo

Drug

Primary outcomes

  1. Investigator's assessment according to the Facial Wrinkle Scale (FWS)

    Time frame: Day 30

    Responder: FWS score of 0 or 1.

  2. Patient's global assessment

    Time frame: Day 30

    Responder: subjects with a score of at least 2+.

Secondary outcomes

  1. Investigator's assessment according to FWS

    Time frame: Day 7, 60, 90, and 120

    Responder: FWS score of 0 or 1.

  2. Patient's global assessment

    Time frame: Day 7, 60, 90, and 120

    Responder: subjects with a score of at least 2+.

Sponsors and collaborators

Lead sponsor

Merz Pharmaceuticals GmbH

Industry

Registry information

Official study title

A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Trial With an Open-label Extension Period to Investigate the Efficacy and Safety of IncobotulinumtoxinA (Xeomin), Free of Complexing Proteins, in the Treatment of Glabellar Frown Lines

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Feb 2, 2007
Registry last updated
Oct 26, 2011

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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