Glabellar Rhytides
Conditions
Keywords
Botulinum Toxin Type A, Botulinum Toxin, Glabellar Rhytides, Rhytides, Frown Lines, Neuromuscular Agents, Neurotoxin, Forehead, Eyebrow, Wrinkle
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)
Interventions
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).
DRUGMentor 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.
Sponsors
Quintiles, Inc.
Mentor Worldwide, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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; 2. In good physical and mental health as determined by the investigator based on medical history, physical examination, and/or clinical laboratory tests; 3. Noticeable presence of the glabellar rhytides for a period of 6 months or longer; 4. 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 5. 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
1. History of psychiatric problems that, in the investigator's opinion, is severe enough potentially to interfere with subject outcomes; 2. History of autoimmune disease, that, in the opinion of the investigator, might interfere with subject outcomes (e.g., osteoarthritis is not considered an
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Degree of glabellar rhytide reduction assessed by the investigator and the subject at maximum frown as a single composite effectiveness endpoint. | 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. | Throughout |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed