Overview

This trial is active, not recruiting.

Conditions lateral canthus rhytides, crow's feet lines
Treatments botulinum toxin type a (24 u), botulinum toxin type a (12 u), normal saline
Phase phase 3
Sponsor Allergan
Start date January 2013
End date July 2013
Trial size 300 participants
Trial identifier NCT01797081, 191622-114

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 Canthal Rhytides).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
24 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
botulinum toxin type a (24 u) BOTOX®
24 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas per treatment.
(Experimental)
12 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
botulinum toxin type a (12 u) BOTOX®
12 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas per treatment.
(Other)
Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (24 U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A).
botulinum toxin type a (24 u) BOTOX®
24 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas per treatment.
normal saline
Normal saline (placebo) injected into bilateral Crow's Feet Line areas per treatment.
(Other)
Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (12 U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A).
botulinum toxin type a (12 u) BOTOX®
12 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas per treatment.
normal saline
Normal saline (placebo) injected into bilateral Crow's Feet Line areas per treatment.

Primary Outcomes

Measure
Investigator's Assessment of the Severity of Crow's Feet Lines at Maximum Smile Using the Facial Wrinkle Scale
time frame: Day 30

Secondary Outcomes

Measure
Investigator's Assessment of the Severity of Crow's Feet Lines at Rest Using the Facial Wrinkle Scale
time frame: Day 30
Subject's Assessment of Appearance of Crow's Feet Lines as Measured by the Facial Line Outcomes Questionnaire
time frame: Day 30
Subject's Assessment of Age-related Facial Appearance as Measured by the Self-Perception of Age Questionnaire
time frame: Day 30

Eligibility Criteria

Male or female participants from 20 years up to 64 years old.

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)

Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Allergan.