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

Crow's Feet Lines Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01797081
• Other study ID #: 191622-114
• Status: Completed
• Phase: Phase 3
• Start date: January 31, 2013
• Est. completion date: July 7, 2014

Study information

• Verified date: April 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 7, 2014
• Est. primary completion date: July 18, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 64 Years

Eligibility

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)

Related Conditions & MeSH terms

• Crow's Feet Lines
• Lateral Canthus Rhytides

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Harii K, Kawashima M, Furuyama N, Lei X, Hopfinger R, Lee E. OnabotulinumtoxinA (Botox) in the Treatment of Crow's Feet Lines in Japanese Subjects. Aesthetic Plast Surg. 2017 Oct;41(5):1186-1197. doi: 10.1007/s00266-017-0844-9. Epub 2017 Jul 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 30
Secondary	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.	Day 30
Secondary	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.	Day 30
Secondary	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.	Day 30