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

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ClinicalTrials.gov Identifier: NCT00430963
Recruitment Status : Completed
First Posted : February 2, 2007
Last Update Posted : October 26, 2011
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH

Brief Summary:
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 or disease Intervention/treatment Phase
Glabellar Frown Lines Drug: IncobotulinumtoxinA (Xeomin) (20 Units) Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : October 2006
Actual Primary Completion Date : April 2007
Actual Study Completion Date : November 2007

Arm Intervention/treatment
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
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)



Primary Outcome Measures :
  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 Outcome Measures :
  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+.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00430963


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

Responsible Party: Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT00430963     History of Changes
Other Study ID Numbers: MRZ 60201-0520/1
First Posted: February 2, 2007    Key Record Dates
Last Update Posted: October 26, 2011
Last Verified: October 2011

Additional relevant MeSH terms:
incobotulinumtoxinA
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents