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")
Overview
- Phase
- Phase 3
- Intervention
- Mentor Purified Toxin
- Conditions
- Glabellar Rhytides
- Sponsor
- Mentor Worldwide, LLC
- Enrollment
- 402
- Locations
- 1
- Primary Endpoint
- Degree of glabellar rhytide reduction assessed by the investigator and the subject at maximum frown as a single composite effectiveness endpoint.
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief 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.
Detailed Description
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)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female subjects who are 18 years of age or older (subjects should have an interest in the effacement of glabellar rhytides) with or without previous botulinum Toxin Type A exposure;
- •In good physical and mental health as determined by the investigator based on medical history, physical examination, and/or clinical laboratory tests;
- •Noticeable presence of the glabellar rhytides for a period of 6 months or longer;
- •Score at least a 2 (moderate severity) at baseline screening on the investigator's and subject's assessments (reference photographs provided) at forced frown; and
- •Capable of understanding and complying with the protocol and must have signed the informed consent document prior to performance of any study-related procedures.
Exclusion Criteria
- •History of psychiatric problems that, in the investigator's opinion, is severe enough potentially to interfere with subject outcomes;
- •History of autoimmune disease, that, in the opinion of the investigator, might interfere with subject outcomes (e.g., osteoarthritis is not considered an exclusion criteria; however, subjects with dermatomyositis are not permitted to participate in this study);
- •History or presence of clinically significant cardiovascular, respiratory, hepatic/biliary, renal, gastrointestinal, endocrinological, or neurological disorders constituting a possible risk factor that, in the investigator's opinion, is severe enough potentially to interfere with subject outcomes;
- •Inability to substantially efface glabellar lines by manually spreading skin apart;
- •Eyelid ptosis;
- •Myasthenia gravis (from medical history or diseases of neurotransmission);
- •Current history of facial nerve paralysis;
- •Concurrent dermatologic disease of the face in the glabellar area that is deemed by the investigator to make the subject an inappropriate candidate for the study;
- •Recent flu-like syndrome that, in the investigator's opinion, is severe enough potentially to interfere with subject outcomes;
- •Neuromuscular disorder that, in the investigator's opinion, is severe enough potentially to interfere with subject outcomes;
Arms & Interventions
1
Mentor Purified Toxin Botulinum Toxin Type A
Intervention: Mentor Purified Toxin
2
Preservative-free Saline
Intervention: Preservative-free Saline
Outcomes
Primary Outcomes
Degree of glabellar rhytide reduction assessed by the investigator and the subject at maximum frown as a single composite effectiveness endpoint.
Time Frame: Day 30 post-injection
Measurement of the incidences of treatment-emergent adverse events, serious treatment-emergent adverse events, treatment-emergent laboratory abnormalities, and vital signs.
Time Frame: Throughout
Secondary Outcomes
- Degree of glabellar rhytide reduction assessed by the investigator and the subject at maximum frown.(Days 3, 7 and 30 post-injection)
- Degree of glabellar rhytide reduction assessed by the investigator and the subject at rest.(Day 30 Post-injection)
- Degree of glabellar rhytide reduction assessed by independent reviewers based on photographs of the subject's glabellar lines at maximum frown.(Baseline and Day 30 post-injection)
- Explore the global satisfaction of the subject with the treatment.(Day 30 post-injection)