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Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines

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ClinicalTrials.gov Identifier: NCT01224015
Recruitment Status : Completed
First Posted : October 19, 2010
Results First Posted : February 25, 2014
Last Update Posted : February 25, 2014
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
This study will evaluate the safety and efficacy of botulinum toxin type A compared to placebo for the treatment of Crow's Feet Lines and Frown Lines (Facial Rhytides) for patients who successfully completed Study 191622-099.

Condition or disease Intervention/treatment Phase
Facial Rhytides Crow's Feet Lines Glabellar Lines Drug: normal saline Biological: onabotulinumtoxinA 44 U Biological: onabotulinumtoxinA 24 U Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 684 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : May 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Foot Health

Arm Intervention/treatment
onabotulinumtoxinA 24U
24 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study.
Drug: normal saline
Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study.

Biological: onabotulinumtoxinA 24 U
24 units onabotulinumtoxinA (botulinum toxin type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study.
Other Names:
  • BOTOX®
  • BOTOX® Cosmetic
  • onabotulinumtoxinA

Placebo Comparator: placebo (normal saline)
Normal Saline (placebo) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study.
Drug: normal saline
Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study.

Experimental: onabotulinumtoxinA 44U
44 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study.
Biological: onabotulinumtoxinA 44 U
44 units onabotulinumtoxinA (botulinum toxin type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study.
Other Names:
  • BOTOX®
  • BOTOX® Cosmetic
  • onabotulinumtoxinA




Primary Outcome Measures :
  1. Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines [ Time Frame: Day 30 ]
    The investigator assessed the severity of the patient's Crow's Feet Lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported.



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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:

  • Successfully completed Study 191622-099

Exclusion Criteria:

  • Known immunization or hypersensitivity to botulinum toxin of any serotype
  • Anticipated need for treatment with botulinum toxin of any serotype during the study (except for study treatment)
  • Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
  • Anticipated need for surgery or hospitalization during the study

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): NCT01224015


Locations
United States, California
Newport Beach, California, United States
Canada, British Columbia
Vancouver, British Columbia, Canada
France
Antibes, France
Germany
Berlin, Germany
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01224015     History of Changes
Other Study ID Numbers: 191622-104
2010-021271-83 ( EudraCT Number )
First Posted: October 19, 2010    Key Record Dates
Results First Posted: February 25, 2014
Last Update Posted: February 25, 2014
Last Verified: February 2014

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