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Completed

NCT Number: NCT00430586

Finding of Optimal Dose for NT 201 in the Treatment of Glabellar Frown Lines

NT 201 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, NT 201 causes local weakening to full paralysis depending on the administered dose. Botulinum toxin type A is widely used for aesthetic treatment of facial lines. This study will determine the optimal dose of NT 201 in the treatment of 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

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

Botulinum neurotoxin type A, free of complexing proteins

Drug

Single treatment with 10, 20 or 30 Units of NT 201 given as intramuscular treatment injections of equal amount to 5 sites on Day 0. The same volume of reconstituted study medication (0.6 mL per subject) was administered irrespective of the treatment group. The total dose volume was administered in equal aliquots to the 5 injection sites. Thus, each of the 5 injection sites was injected with 0.12 mL study medication per injection site.

Other names: BTX-A,, BoNT/A,, incobotulinumtoxinA (Xeomin)

Placebo

Drug

Single treatment with Placebo given as intramuscular treatment injections of equal amount to 5 sites on Day 0. A volume of reconstituted 0.6 mL per subject was administered. The total dose volume was administered in equal aliquots to the 5 injection sites. Thus, each of the 5 injection sites was injected with 0.12 mL Placebo per injection site.

Primary outcomes

  1. Percentage of responders at maximum frown at Day 30 as assessed by the investigator according to Facial Wrinkle Scale (FWS)

    Time frame: Baseline (Day 0) to Day 30

    Responders on the FWS are defined as subjects with glabellar line severity of none (0) or mild (1).

    The Primary Analysis Set (PAS) will be used for all confirmatory tests for the primary efficacy variables of the co-primary endpoint. The PAS will consist of all subjects in the Full Analysis Set who have available assessments by the investigator for severity of glabellar frown lines at maximum frown on Day 30, as well as patient's assessment at Day 0 and Day 30. All analyses for this population will therefore use the same sample for both primary endpoints.

  2. Percentage of responders at maximum frown at Day 30 as assessed by patient's assessment according to 4-point scale

    Time frame: Baseline (Day 0) to Day 30

    Responders will be subjects with at least a 1-point improvement compared to Day 0.

    The Primary Analysis Set (PAS) will be used for all confirmatory tests for the primary efficacy variables of the co-primary endpoint. The PAS will consist of all subjects in the Full Analysis Set who have available assessments by the investigator for severity of glabellar frown lines at maximum frown on Day 30, as well as patient's assessment at Day 0 and Day 30. All analyses for this population will therefore use the same sample for both primary endpoints.

Secondary outcomes

  1. Percentage of responders at maximum frown at Day 90 as assessed by the investigator according to FWS

    Time frame: Baseline (Day 0) to Day 90

    Responders on the FWS are defined as subjects with glabellar line severity of none (0) or mild (1).

    Secondary efficacy endpoints will be analyzed analogously to the analysis of primary efficacy endpoint.

  2. Percentage of responders at maximum frown at Day 90 as assessed by patient's assessment

    Time frame: Baseline (Day 0) to Day 90

    Responders will be subjects with at least a 1-point improvement compared to Day 0.

    Secondary efficacy endpoints will be analyzed analogously to the analysis of primary efficacy endpoint.

Sponsors and collaborators

Lead sponsor

Merz Pharmaceuticals GmbH

Industry

Registry information

Official study title

A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Trial to Determine the Optimal Dose of NT 201, Free of Complexing Proteins, in the Treatment of Glabellar Frown Lines

Important dates

Study start
2006
Study completion
2007
First posted
Feb 2, 2007
Registry last updated
Aug 3, 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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