Safety and Efficacy Study of PurTox® Botulinum Toxin Type A to Treat Frown Lines Between the Eyebrows

NCT00752297 | Completed Phase 3

• 1 other identifier: PT-03a
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 1

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.

Conditions

Glabellar Rhytides

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

Mentor Purified Toxin Botulinum Toxin Type A

Drug: Mentor Purified Toxin

2

PLACEBO COMPARATOR

Preservative-free Saline

Drug: Preservative-free Saline

Interventions

Preservative-free Saline DRUG

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).

Also known as: Saline

2

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

Also known as: Arms: 1, Other Names:, Mentor Purified Toxin Botulinum Toxin Type A, 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 (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.

You may not qualify if:

• History of psychiatric problems that, in the investigator's opinion, is severe enough potentially to interfere with subject outcomes;
• 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;
• 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 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 use appropriate birth control (see protocol/informed consent for description)

Sponsors & Collaborators

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

Study Sites (1)

Mentor Worldwide, LLC

Santa Barbara, California, 93111, United States

Location

MeSH Terms

Interventions

Sodium Chloride; Botulinum Toxins, Type A; Botulinum Toxins

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; 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, MD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2008
• First Posted: September 15, 2008
• Study Start: June 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: September 12, 2011

Record last verified: 2011-09

Locations

US (1)