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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT00430963
First received: February 1, 2007
Last updated: October 25, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Glabellar Frown Lines
 Drug: IncobotulinumtoxinA (Xeomin) (20 Units)
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Botox
U.S. FDA Resources

Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:
  • Investigator's assessment according to the Facial Wrinkle Scale (FWS) [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    Responder: FWS score of 0 or 1.

  • Patient's global assessment [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    Responder: subjects with a score of at least 2+.


Secondary Outcome Measures:
  • Investigator's assessment according to FWS [ Time Frame: Day 7, 60, 90, and 120 ] [ Designated as safety issue: No ]
    Responder: FWS score of 0 or 1.

  • Patient's global assessment [ Time Frame: Day 7, 60, 90, and 120 ] [ Designated as safety issue: No ]
    Responder: subjects with a score of at least 2+.


Enrollment: 256
Study Start Date: October 2006
Study Completion Date: November 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding to total placebo volume 0.5 mL; mode of administration: intramuscular injection
 Drug: Placebo
Other Name: Placebo
Experimental: IncobotulinumtoxinA (Xeomin) (20 Units)
IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin type A free from complexing proteins) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% sodium chloride (NaCl), 20 units, total volume 0.5 mL, mode of administration: intramuscular injection
 Drug: IncobotulinumtoxinA (Xeomin) (20 Units)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

•Moderate to severe glabellar frown lines

Exclusion Criteria:

  • Previous insertion of permanent material in the glabellar area
  • Neuromuscular function disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00430963

Locations
Germany
Merz Pharmaceuticals GmbH
Frankfurt, Germany, 60318
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
Investigators
Study Director: Medical Expert Merz Pharmaceuticals GmbH
  More Information

No publications provided

Responsible Party: Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT00430963     History of Changes
Other Study ID Numbers: MRZ 60201-0520/1
Study First Received: February 1, 2007
Last Updated: October 25, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013