Status:
COMPLETED
Safety and Efficacy Study of Repeat Treatment With PurTox® Botulinum Toxin Type A for Frown Lines Between the Eyebrows
Lead Sponsor:
Mentor Worldwide, LLC
Collaborating Sponsors:
Synteract, Inc.
Conditions:
Glabellar Rhytides
Frown Lines Between the Eyebrows
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 plac...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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;
- Active multisystems disease that, in the investigator's opinion, might influence the outcome measures or the safety of the subject;
- Has any condition(s) that in the investigator's opinion would a) warrant exclusion from the study, or b) prevent the subject from completing the study;
- Currently receiving aminoglycoside antibiotic therapy, curare-like drugs, quinidine, succinylcholine, polymyxins, anticholinesterases, magnesium sulfate, or lincosamides;
- Has taken any investigational drug during the 30 days prior to screening visit;
- Have had Botulinum Toxin treatments to the glabellar and/or forehead area during the 6 months prior to screening visit;
- Have had dermal filler treatment to glabellar area during the 6 months prior to screening visit;
- Female subjects who are pregnant or lactating. Female subjects who are of childbearing potential must have negative urine pregnancy test results prior to enrollment into the study. Such subjects, including peri-menopausal women who have had a menstrual period within one year, must be using appropriate birth control (see protocol/informed consent for description);
- Unwilling or unable to comply with the protocol or to cooperate fully with the investigator and site personnel; and
- Unable to understand verbal and/or written English or any other language in which a certified translation of the informed consent document is available.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
699 Patients enrolled
Trial Details
Trial ID
NCT00752050
Start Date
November 1 2007
End Date
March 1 2009
Last Update
September 12 2011
Active Locations (1)
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1
Mentor Wordwide, LLC
Santa Barbara, California, United States, 93111