A Phase 3, Multi-Center Trial to Demonstrate the Safety and Efficacy of Repeat Treatment With PurTox® for the Treatment of Glabellar Rhytides ("Frown Lines")
Overview
- Phase
- Phase 3
- Intervention
- Mentor Purified Toxin Botulinum Toxin Type A
- Conditions
- Glabellar Rhytides
- Sponsor
- Mentor Worldwide, LLC
- Enrollment
- 699
- Locations
- 1
- Primary Endpoint
- Change in assessments of severity of glabellar rhytide 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 repeat treatment of an intramuscular dose of Mentor Purified Toxin for the reduction of frown lines, compared with placebo.
Detailed Description
The purpose of this a randomized withdrawal Phase III, multi-center research study is to evaluate the safety and effectiveness of repeat treatment with an intramuscular dose of Mentor Purified Toxin in the reduction of glabellar rhytides (frown lines). Approximately 700 subjects will be enrolled at approximately 12 clinical sites in the U.S.A. Effectiveness 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) There are two parts to this study. In the first part, all study participants will receive treatment with an intramuscular injection of 30 Units of Mentor Purified Toxin on two separate occasions (Cycles 1 and 2) no more than 6 months apart. In the second part of the study (Cycle 3), subjects will be randomly assigned to receive either intramuscular injections of 30 Units of Mentor Purified Toxin or placebo (preservative-free saline) and subjects will be followed for 1 month (3:1, PurTox : placebo). Each subject will receive five intramuscular injections for a total of 0.5 mL of study drug in the glabellar area, during each treatment visit. Participation takes place over a maximum of 14 months, including Part 1 (Cycle 1 and 2) and Part 2 (Cycle 3). The number of clinic visits will vary from person to person depending upon the subject's response to the study drug, but will range from approximately 9 to 19 clinic visits. There will also be up to 4 telephone follow-up contacts.
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
- •A history of psychiatric problems that, in the investigator's opinion, is severe enough potentially to interfere with subject outcomes;
- •A 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);
- •A 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 - Part II ONLY. (Part I is Single Group and all participants receive active drug and are not randomized)
Intervention: Mentor Purified Toxin Botulinum Toxin Type A
2
Preservative-free Saline - Part II ONLY. (Part I is Single Group and all participants receive active drug and are not randomized)
Intervention: Preservative-free Saline
Outcomes
Primary Outcomes
Change in assessments of severity of glabellar rhytide by the investigator and the subject at maximum frown as a single composite effectiveness endpoint.
Time Frame: Day 30 post randomization
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
- Change in assessments of severity of glabellar rhytide by the investigator and the subject at maximum frown.(Day 30 post-injection)
- Change in assessments of severity of glabellar rhytide by the investigator and the subject at rest.(Day 30 post randomization)
- Change in assessments of severity of glabellar rhytide by independent reviewers based on the photographs of the subject's glabellar lines at maximum frown.(Baseline and Day 30 post randomization)