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

NCT01189760 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 917

Last updated 2019-04-16

Study results available
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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 and Frown Lines (Facial Rhytides)

Conditions

  • Facial Rhytides
  • Crow's Feet Lines
  • Glabellar Lines

Interventions

BIOLOGICAL

onabotulinumtoxinA 24 U

24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients will receive two treatments 4 months apart.

BIOLOGICAL

onabotulinumtoxinA 44 U

44 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients will receive two treatments 4 months apart

DRUG

normal saline

Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients will receive two treatments 4 months apart.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-01
Primary Completion
2011-03-01
Completion
2011-09-01

Countries

  • United States
  • Canada
  • France
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01189760 on ClinicalTrials.gov