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

NCT01224015 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 684

Last updated 2014-02-25

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) for patients who successfully completed Study 191622-099.

Conditions

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

Interventions

DRUG

normal saline

Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study.

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 may receive up to 2 treatments during the study.

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 may receive up to 2 treatments during the study.

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
2011-05-31
Primary Completion
2011-10-31
Completion
2012-02-29

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 NCT01224015 on ClinicalTrials.gov