A Long-Term Safety Study of Repeat Treatment With PurTox® for Frown Lines Between the Eyebrows

NCT00752258 | Completed Phase 3

• 1 other identifier: PT-03c
• Study Type: interventional
• Target: 576
• Locations: 1 country
• Sites: 1

Brief Summary

The overall purpose of this study is to evaluate the long-term safety of repeat treatment with an intramuscular dose of Mentor Purified Toxin for the reduction of frown lines.

Conditions

Glabellar Rhytides

Keywords

Botulinum Toxin Type A; Botulinum Toxin; Glabellar Rhytides; Rhytides; Frown Lines; Neuromuscular Agents; Neurotoxin; Forehead; Eyebrow; Wrinkle; Frown Lines Between the Eyebrows

Outcome Measures

Primary Outcomes (1)

• Estimation of the incidences of treatment-emergent adverse events, serious treatment-emergent adverse events, and treatment-emergent laboratory abnormalities, when PurTox is administered in repeated treatments.

  Throughout

Secondary Outcomes (4)

• Estimate across treatment cycles the frequency with which subjects are responders at Day 30, based on an assessment of rhytide severity at maximum frown of 0 or 1 by the investigator

  Day 30/Across all Treatment Cycles

• Estimate across treatment cycles the frequency with which subjects are responders at Day 30, based on an assessment of rhytide severity at maximum frown of 0 or 1 by the subject

  Day 30/Across treatment all cycles

• Estimate across treatment cycles the frequency with which subjects are responders at Day 30, based on assessments of rhytide severity at maximum frown of 0 or 1 by both the investigator and the subject

  Day 30/Across all treatment cycles

• Estimate across treatment cycles the frequency with which subjects, who are responders at Day 30, based on subject assessment at maximum frown, continue to be responders at Days 90, 120, 150, and 180.

  Day 30 through Day 180/Across all treatment cycles

Study Arms (1)

1

EXPERIMENTAL

Mentor Purified Toxin Botulinum Toxin Type A

Drug: Mentor Purified Toxin Botulinum Toxin Type A

Interventions

Mentor Purified Toxin Botulinum Toxin Type A DRUG

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 Mentor Purified Toxin. Subjects will have many Treatment Visits throughout the course of the three-year study.

Also known as: Botulinum Toxin Type A, Botulinum Toxin

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects who are 18 years of age or older with 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.

You may not qualify if:

• A history of psychiatric problems that, in the investigator's opinion, is severe enough potentially to interfere with subject outcomes;
• A history or presence of clinically significant cardiovascular, respiratory, hepatic/biliary, renal, gastrointestinal, endocrine, 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 or diseases of neurotransmission (from medical history);
• 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;
• 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 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; or

Sponsors & Collaborators

• Mentor Worldwide, LLC: lead
• Synteract, Inc.: collaborator

Study Sites (1)

Mentor Worldwide, LLC

Santa Barbara, California, 93111, United States

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A; Botulinum Toxins

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Corey Maas

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2008
• First Posted: September 15, 2008
• Study Start: February 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: September 12, 2011

Record last verified: 2011-09

Locations

US (1)