Safety and Efficacy Study of Repeat Treatment With PurTox® Botulinum Toxin Type A for Frown Lines Between the Eyebrows

NCT00752050 | Completed Phase 3

• 1 other identifier: PT-03b
• Study Type: interventional
• Target: 699
• Locations: 1 country
• Sites: 1

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.

Conditions

Glabellar Rhytides; Frown Lines Between the Eyebrows

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in assessments of severity of glabellar rhytide by the investigator and the subject at maximum frown as a single composite effectiveness endpoint.

  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.

  Throughout

Secondary Outcomes (3)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

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)

Drug: Mentor Purified Toxin Botulinum Toxin Type A

2

PLACEBO COMPARATOR

Preservative-free Saline - Part II ONLY. (Part I is Single Group and all participants receive active drug and are not randomized)

Drug: Preservative-free Saline

Interventions

Mentor Purified Toxin Botulinum Toxin Type A DRUG

For Part II, subjects in this arm 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 30 U of the Active Comparator Mentor Purified Toxin.

Also known as: Botulinum Toxin Type A, Botulinum Toxin

1

Preservative-free Saline DRUG

For Part II, subjects in this arm 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

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:

• 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, 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 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);

Sponsors & Collaborators

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

Study Sites (1)

Mentor Wordwide, LLC

Santa Barbara, California, 93111, United States

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A; Botulinum Toxins; Sodium Chloride

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

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 11, 2008
• First Posted: September 15, 2008
• Study Start: November 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: March 1, 2009
• Last Updated: September 12, 2011

Record last verified: 2011-09

Locations

US (1)