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

PHASE3CompletedINTERVENTIONAL
Enrollment

699

Participants

Timeline

Start Date

November 30, 2007

Primary Completion Date

February 28, 2009

Study Completion Date

March 31, 2009

Conditions
Glabellar RhytidesFrown 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).

Trial Locations (1)

93111

Mentor Wordwide, LLC, Santa Barbara

All Listed Sponsors
collaborator

Synteract, Inc.

INDUSTRY

lead

Mentor Worldwide, LLC

INDUSTRY

NCT00752050 - Safety and Efficacy Study of Repeat Treatment With PurTox® Botulinum Toxin Type A for Frown Lines Between the Eyebrows | Biotech Hunter | Biotech Hunter