Glabellar Rhytides Clinical Trial
Official title:
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Two-Arm, Single-Dose Pivotal Trial to Demonstrate the Safety and Efficacy of PurTox® for the Treatment of Glabellar Rhytides ("Frown Lines")
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.
This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, two-arm,
single-dose study to evaluate the safety and efficacy of Mentor Purified Toxin for the
treatment of glabellar rhytides. Approximately 400 subjects will be enrolled in the study.
The subjects will be randomized 3:1 (300 Mentor Purified Toxin: 100 placebo) to receive
either intramuscular injections of 30 U of Mentor Purified Toxin or placebo
(preservative-free saline).
Injected subjects will be observed for 180 days of post treatment follow-up. Follow-up
clinic visits are scheduled for post treatment days 3, 7, 14, 30, 60, 90, 120, 150, and 180.
The study will be conducted at up to ten clinical sites. Safety, tolerability, clinical
efficacy, onset and duration of effect will be studied during the study
The effectiveness of Mentor Purified Toxin will be determined by the degree of frown line
reduction, during maximum forced frown and at rest (neutral expression):
- as assessed live by the study doctor,
- as assessed live by the subject, and
- as assessed by an independent reviewer based on subject photographs
Frown lines are graded on level of severity based on this scale:
Severity
- Minimal (0)
- Mild (1)
- Moderate (2)
- Severe (3)
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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