BOTOX® in the Treatment of Crow's Feet Lines in Japan

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01797081
First received: February 20, 2013
Last updated: January 27, 2015
Last verified: January 2015
  Purpose

This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) compared to placebo for the treatment of Crow's Feet Lines (Lateral Canthus Rhytides).


Condition Intervention Phase
Lateral Canthus Rhytides
Crow's Feet Lines
Biological: botulinum toxin Type A (24 U)
Biological: botulinum toxin Type A (12 U)
Other: Normal Saline
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:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Participants Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A) [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    The Investigator assessed the severity of the patient's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale where 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.


Secondary Outcome Measures:
  • Percentage of Participants Achieving a ≥1-Grade Improvement From Baseline on the Investigator's Assessment of the Severity of CFL at Rest Using the FWS-A [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    The Investigator assessed the severity of the participant's Crow's Feet Lines at rest using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥1-grade improvement from Baseline at Day 30 is reported.

  • Percentage of Participants Much Improved or Very Much Improved in the Subject's Assessment of Appearance of CFL as Measured by the Global Assessment of Change in Crow's Feet Lines [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    Participants rated the change in their Crow's Feet Lines using the Subject's Global Assessment of Change in Crow's Feet Lines (SGA-CFL) 7-point scale where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse or 7=very much worse. The percentage of participants who reported Much Improved or Very Much Improved at Day 30 is reported.

  • Percentage of Participants Who Rate Themselves in a Younger Self-Perception of Age Category Than at Baseline [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    Participants were considered to judge themselves as looking younger if the category change was from "look my current age" at Baseline to "look younger" at Day 30 or from "look older" at Baseline to "look my current age/younger" at Day 30.


Enrollment: 300
Study Start Date: January 2013
Study Completion Date: July 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Botulinum toxin Type A (24U)
24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
Biological: botulinum toxin Type A (24 U)
24 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas per treatment.
Other Name: BOTOX®
Experimental: Botulinum toxin Type A (12U)
12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
Biological: botulinum toxin Type A (12 U)
12 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas per treatment.
Other Name: BOTOX®
Placebo/Botulinum toxin Type A (24U)
Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (24U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A).
Biological: botulinum toxin Type A (24 U)
24 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas per treatment.
Other Name: BOTOX®
Other: Normal Saline
Normal saline (placebo) injected into bilateral Crow's Feet Line areas per treatment.
Placebo/Botulinum toxin Type A (12U)
Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (12U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A).
Biological: botulinum toxin Type A (12 U)
12 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas per treatment.
Other Name: BOTOX®
Other: Normal Saline
Normal saline (placebo) injected into bilateral Crow's Feet Line areas per treatment.

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-Moderate to severe Crow's Feet Lines

Exclusion Criteria:

  • Current or previous botulinum toxin treatment of any serotype
  • Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
  • Facial laser or light treatment for cosmetic purposes, microdermabrasion, superficial peels, or topical retinoid therapy or hormone cream within 3 months
  • Laser treatment or phototherapy of the face for medical purposes, blepharoplasty, brow-lift or related procedure, periorbital permanent make-up, or oral retinoid therapy within one year
  • Medium-depth or deep facial peels within 5 years
  • Prior facial cosmetic surgery (e.g., prior periorbital surgery, facial lift, periorbital treatment with fillers, implantation or transplantation)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01797081

Locations
Japan
Tokyo, Japan
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01797081     History of Changes
Other Study ID Numbers: 191622-114
Study First Received: February 20, 2013
Results First Received: January 27, 2015
Last Updated: January 27, 2015
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on March 30, 2015