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

PHASE3CompletedINTERVENTIONAL
Enrollment

402

Participants

Timeline

Start Date

June 30, 2007

Primary Completion Date

May 31, 2008

Study Completion Date

May 31, 2008

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.

Trial Locations (1)

93111

Mentor Worldwide, LLC, Santa Barbara

All Listed Sponsors
collaborator

Quintiles, Inc.

INDUSTRY

lead

Mentor Worldwide, LLC

INDUSTRY

NCT00752297 - Safety and Efficacy Study of PurTox® Botulinum Toxin Type A to Treat Frown Lines Between the Eyebrows | Biotech Hunter | Biotech Hunter