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

Allergan300 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

300

Conditions

Lateral Canthus Rhytides Crow's Feet Lines

Interventions

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.

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.

Normal SalineOTHER

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 64 Years

Medical Language ↔ Plain English

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)

Locations (1)

Unnamed facility

Tokyo, Japan

Outcomes

Primary Outcomes

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)

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.

Time frame: Day 30

Secondary Outcomes

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

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.

Time frame: Day 30

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

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.

Time frame: Day 30

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

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.

Time frame: Day 30

Data from ClinicalTrials.gov

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