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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01797081
Other study ID # 191622-114
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
See also
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Completed NCT02195687 - BOTOX® in the Treatment of Crow's Feet Lines in China Phase 3
Completed NCT01189760 - Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines Phase 3
Completed NCT01189747 - Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines Phase 3
Recruiting NCT04081402 - A Phase 1/3 Clinical Trial to Evaluate the Safety and Efficacy of HUTOX Compared to Botox® in Subjects With Moderate to Severe Crow's Feet Lines Phase 3
Completed NCT01224015 - Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines Phase 3
Completed NCT02176356 - Patient Satisfaction Study of Combined Facial Treatment With BOTOX® Cosmetic, JUVÉDERM® and LATISSE® (HARMONY Study) Phase 4
Not yet recruiting NCT06402058 - A Study Comparing DMSB01 and Rejuran® for Temporary Crow's Feet Lines Improvement N/A
Completed NCT06376838 - To Prove the Non-inferiority of DLMR01 by Evaluating the Injecting Efficacy and Safety DLMR01 and Control for Patients in Crow's Feet N/A
Not yet recruiting NCT03184363 - Efficacy and Safety of DWP450 for Treating Crows Feet Lines(CFL) in Combination With Glabellar Lines(Extension Study) Phase 3
Completed NCT03408236 - Evaluate the Safety and Efficacy of Botulax® as Compared to Botox® in Subject With Moderate to Severe Crow's Feet Lines Phase 3
Completed NCT01797094 - BOTOX® in the Treatment of Upper Facial Lines in Japan Phase 3
Completed NCT03317574 - MEDITOXIN® in Treatment of Crow's Feet Line Phase 3