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Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Forehead and Frown Lines

NCT01391299 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2019-04-17

Study results available
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Summary

This study evaluated the safety and efficacy of botulinum toxin Type A compared to placebo for the treatment of forehead lines (facial rhytides) when also administered to frown lines (glabellar rhytides).

Conditions

  • Facial Rhytides
  • Glabellar Frown Lines

Interventions

BIOLOGICAL

botulinum toxin Type A

Botulinum toxin Type A (total dose 30 Units or 40 Units) injected into bilateral forehead and frown line areas on Day 1.

DRUG

Normal Saline

Normal Saline (placebo) injected into bilateral forehead and frown line areas on Day 1.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-01
Primary Completion
2011-10-18
Completion
2012-02-28

Countries

  • Canada

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 NCT01391299 on ClinicalTrials.gov