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Safety and Efficacy Study of PurTox® Botulinum Toxin Type A to Treat Frown Lines Between the Eyebrows

NCT00752297 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 402

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 an intramuscular dose of Mentor Purified Toxin for the reduction of frown lines, compared with placebo.

Conditions

  • Glabellar Rhytides

Interventions

DRUG

Preservative-free Saline

Subjects 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).

DRUG

Mentor Purified Toxin

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 PurTox. Subjects will have many Treatment Visits throughout the course of the three-year study.

Sponsors & Collaborators

  • Quintiles, 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
2007-06-30
Primary Completion
2008-05-31
Completion
2008-05-31

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 NCT00752297 on ClinicalTrials.gov