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

NCT ID: NCT01189747

Last Updated: 2019-05-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

446 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-01

Study Completion Date

2011-07-01

Brief Summary

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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).

Detailed Description

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Conditions

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Lateral Canthus Rhytides Crow's Feet Lines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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onabotulinumtoxinA

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

Group Type EXPERIMENTAL

onabotulinumtoxinA

Intervention Type BIOLOGICAL

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

placebo (normal saline)

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

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

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

Interventions

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onabotulinumtoxinA

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

Intervention Type BIOLOGICAL

normal saline

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

Intervention Type DRUG

Other Intervention Names

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BOTOX® BOTOX® Cosmetic

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Newport Beach, California, United States

Site Status

Aalst, , Belgium

Site Status

Vancouver, British Columbia, Canada

Site Status

Sutton Coldfield, England, United Kingdom

Site Status

Countries

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United States Belgium Canada United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 25347451 (View on PubMed)

Other Identifiers

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191622-098

Identifier Type: -

Identifier Source: org_study_id

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