ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

October 18, 2010
October 19, 2010
September 27, 2013
February 25, 2014
February 25, 2014
May 2011
October 2011   (Final data collection date for primary outcome measure)
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.
Investigator's assessment of the severity of Crow's Feet Lines at maximum smile using the Facial Wrinkle Scale [ Time Frame: Day 30 ]
Complete list of historical versions of study NCT01224015 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines
Not Provided
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Facial Rhytides
  • Crow's Feet Lines
  • Glabellar Lines
  • 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 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
  • 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
  • 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.
    Interventions:
    • Drug: normal saline
    • Biological: onabotulinumtoxinA 24 U
  • 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.
    Intervention: Drug: normal saline
  • 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.
    Intervention: Biological: onabotulinumtoxinA 44 U
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
684
900
February 2012
October 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   France,   Germany,   United States
 
 
NCT01224015
191622-104
2010-021271-83 ( EudraCT Number )
No
Not Provided
Not Provided
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP