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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01224015
First received: October 18, 2010
Last updated: October 22, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention Phase
Facial Rhytides
Crow's Feet Lines
Glabellar Lines
 Drug: botulinum toxin type A and Normal Saline (placebo)
Drug: Normal Saline (placebo)
Drug: botulinum toxin type A
 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Investigator's assessment of the severity of Crow's Feet Lines at maximum smile using the Facial Wrinkle Scale [ Time Frame: Day 30 ] [ Designated as safety issue: No ]

Enrollment: 684
Study Start Date: May 2011
Study Completion Date: February 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
botulinum toxin type A and Normal Saline (placebo)
botulinum toxin type A and Normal Saline (placebo)
 Drug: botulinum toxin type A and Normal Saline (placebo)
24 units botulinum toxin type A (total dose) and 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.
Other Name: BOTOX® Cosmetic
Placebo Comparator: Normal Saline (placebo)
Normal Saline (placebo)
 Drug: Normal Saline (placebo)
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.
Experimental: botulinum toxin type A
botulinum toxin type A
 Drug: botulinum toxin type A
44 units 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 Name: BOTOX® Cosmetic

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01224015

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

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01224015     History of Changes
Other Study ID Numbers: 191622-104, 2010-021271-83
Study First Received: October 18, 2010
Last Updated: October 22, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013