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Safety and Efficacy Study of Repeat Treatment With PurTox® Botulinum Toxin Type A for Frown Lines Between the Eyebrows

NCT00752050 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 699

Last updated 2011-09-12

No results posted yet for this study

Summary

The overall purpose of this study is to evaluate the safety and effectiveness of repeat treatment of an intramuscular dose of Mentor Purified Toxin for the reduction of frown lines, compared with placebo.

Conditions

  • Glabellar Rhytides
  • Frown Lines Between the Eyebrows

Interventions

DRUG

Mentor Purified Toxin Botulinum Toxin Type A

For Part II, subjects in this arm will receive five 0.1 mL intramuscular injections at the Day 0 Treatment Visit: two in each corrugator and one in the procerus muscle. The total treatment dose (sum of the five injections) to be administered will be 30 U of the Active Comparator Mentor Purified Toxin.

DRUG

Preservative-free Saline

For Part II, subjects in this arm will receive five 0.1 mL intramuscular injections at the Day 0 Treatment Visit: two in each corrugator and one in the procerus muscle. The total treatment dose (sum of the five injections) to be administered will be 0.5 mL of the placebo (preservative-free saline).

Sponsors & Collaborators

  • Synteract, Inc.

    collaborator INDUSTRY

  • Mentor Worldwide, LLC

    lead INDUSTRY

Principal Investigators

  • Corey Maas, MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2009-02-28
Completion
2009-03-31

Countries

  • United States

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 NCT00752050 on ClinicalTrials.gov