Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines

NCT01189747 | Completed Phase 3 Results

• 1 other identifier: 191622-098
• Study Type: interventional
• Target: 446
• Locations: 4 countries
• Sites: 4

Brief Summary

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

Conditions

Lateral Canthus Rhytides; Crow's Feet Lines

Outcome Measures

Primary Outcomes (1)

• Percentage of Responders Based on Composite Facial Wrinkle Scale Assessment of Crow's Feet Line Severity at Maximum Smile

  The composite facial wrinkle scale assessment is based on both the Investigator and Subject Facial Wrinkle scales at 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: 0=none, 1=mild, 2=moderate or 3=severe and the patient assessed the severity of their Crow's Feet Lines at maximum smile using the same 4-point Facial Wrinkle Scale. A responder is defined as a participant with a ≥ 2-grade improvement from Baseline.

  Baseline, Day 30

Secondary Outcomes (8)

• Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator's Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines

  Day 30

• Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines at Maximum Smile

  Baseline, Day 30

• Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines at Rest

  Baseline, Day 30

• Subject Global Assessment of Change in Crow's Feet Lines (SGA-CFL) Score

  Day 30

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

  Baseline, Day 30

Study Arms (2)

onabotulinumtoxinA

EXPERIMENTAL

24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.

Biological: onabotulinumtoxinA

placebo (normal saline)

PLACEBO COMPARATOR

normal saline injected into bilateral Crow's Feet Line areas on Day 1.

Drug: normal saline

Interventions

onabotulinumtoxinA BIOLOGICAL

24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1

Also known as: BOTOX®, BOTOX® Cosmetic

onabotulinumtoxinA

normal saline DRUG

Injected into bilateral Crow's Feet Line areas on Day 1

placebo (normal saline)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate to severe Crow's Feet Lines
• Have adequate vision without the use of eyeglasses to assess facial wrinkles in a mirror (contact lenses OK)

You may not qualify if:

• Current or previous botulinum toxin treatment of any serotype
• Facial laser or light treatment, microdermabrasion or superficial peels within 3 months
• Oral retinoid therapy within 1 year
• Prior facial cosmetic surgery (eg, periorbital surgery, facial lift, brow lift, eye lift, or eyebrow surgery)
• Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis

Sponsors & Collaborators

• Allergan: lead

Study Sites (4)

Unknown Facility

Newport Beach, California, United States

Location

Unknown Facility

Aalst, Belgium

Location

Unknown Facility

Vancouver, British Columbia, Canada

Location

Unknown Facility

Sutton Coldfield, England, United Kingdom

Location

Related Publications (1)

• Carruthers A, Bruce S, de Coninck A, Connolly S, Cox SE, Davis PG, Campo A, Lei X, Somogyi C, Lee E, McLean H, Beddingfield F. Efficacy and safety of onabotulinumtoxinA for the treatment of crows feet lines: a multicenter, randomized, controlled trial. Dermatol Surg. 2014 Nov;40(11):1181-90. doi: 10.1097/DSS.0000000000000128.

  PMID: 25347451 BACKGROUND

MeSH Terms

Interventions

Botulinum Toxins, Type A; Saline Solution

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2010
• First Posted: August 27, 2010
• Study Start: October 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: July 1, 2011
• Last Updated: May 7, 2019
• Results First Posted: December 3, 2013

Record last verified: 2019-04

Locations

US (1); CA (1); BE (1); GB (1)