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A Long-Term Safety Study of Repeat Treatment With PurTox® for Frown Lines Between the Eyebrows

NCT00752258 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 576

Last updated 2011-09-12

No results posted yet for this study

Summary

The overall purpose of this study is to evaluate the long-term safety of repeat treatment with an intramuscular dose of Mentor Purified Toxin for the reduction of frown lines.

Conditions

  • Glabellar Rhytides

Interventions

DRUG

Mentor Purified Toxin Botulinum Toxin Type A

All subjects will receive five 0.1 mL intramuscular injections (two in each corrugator and one in the procerus muscle) at each Treatment Visit. The total treatment dose (sum of the five injections) to be administered will be 30 U of Mentor Purified Toxin. Subjects will have many Treatment Visits throughout the course of the three-year study.

Sponsors & Collaborators

  • Synteract, Inc.

    collaborator INDUSTRY

  • Mentor Worldwide, LLC

    lead INDUSTRY

Principal Investigators

  • Corey Maas

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2011-05-31
Completion
2011-05-31

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 NCT00752258 on ClinicalTrials.gov