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Completed

NCT Number: NCT01797081

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

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).

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Key information

Conditions

Lateral Canthus Rhytides Crow's Feet Lines

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

botulinum toxin Type A (24 U)

Biological

24 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas per treatment.

Other names: BOTOX®

botulinum toxin Type A (12 U)

Biological

12 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas per treatment.

Other names: BOTOX®

Normal Saline

Other

Normal saline (placebo) injected into bilateral Crow's Feet Line areas per treatment.

Primary outcomes

  1. 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

    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 outcomes

  1. 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

    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.

  2. 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

    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.

  3. Percentage of Participants Who Rate Themselves in a Younger Self-Perception of Age Category Than at Baseline

    Time frame: Day 30

    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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Feb 22, 2013
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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