Safety and Efficacy Study of PurTox® Botulinum Toxin Type A to Treat Frown Lines Between the Eyebrows (PT-03a)

This study has been completed.
Sponsor:
Collaborator:
Quintiles
Information provided by (Responsible Party):
Mentor Worldwide, LLC
ClinicalTrials.gov Identifier:
NCT00752297
First received: September 10, 2008
Last updated: September 1, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Glabellar Rhytides
Drug: Preservative-free Saline
Drug: Mentor Purified Toxin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Two-Arm, Single-Dose Pivotal Trial to Demonstrate the Safety and Efficacy of PurTox® for the Treatment of Glabellar Rhytides ("Frown Lines")

Resource links provided by NLM:


Further study details as provided by Mentor Worldwide, LLC:

Primary Outcome Measures:
  • Degree of glabellar rhytide reduction assessed by the investigator and the subject at maximum frown as a single composite effectiveness endpoint. [ Time Frame: Day 30 post-injection ] [ Designated as safety issue: No ]
  • Measurement of the incidences of treatment-emergent adverse events, serious treatment-emergent adverse events, treatment-emergent laboratory abnormalities, and vital signs. [ Time Frame: Throughout ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Degree of glabellar rhytide reduction assessed by the investigator and the subject at maximum frown. [ Time Frame: Days 3, 7 and 30 post-injection ] [ Designated as safety issue: No ]
  • Degree of glabellar rhytide reduction assessed by the investigator and the subject at rest. [ Time Frame: Day 30 Post-injection ] [ Designated as safety issue: No ]
  • Degree of glabellar rhytide reduction assessed by independent reviewers based on photographs of the subject's glabellar lines at maximum frown. [ Time Frame: Baseline and Day 30 post-injection ] [ Designated as safety issue: No ]
  • Explore the global satisfaction of the subject with the treatment. [ Time Frame: Day 30 post-injection ] [ Designated as safety issue: No ]

Enrollment: 402
Study Start Date: June 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Mentor Purified Toxin Botulinum Toxin Type A
Drug: Mentor 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.
Other Names:
  • Arms: 1
  • Other Names:
  • Mentor Purified Toxin Botulinum Toxin Type A
  • Botulinum Toxin Type A
  • Botulinum Toxin
Placebo Comparator: 2
Preservative-free Saline
Drug: Preservative-free Saline
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).
Other Names:
  • Preservative-free Saline
  • Saline

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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 exclusion criteria; however, subjects with dermatomyositis are not permitted to participate in this study);
  3. 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;
  4. Inability to substantially efface glabellar lines by manually spreading skin apart;
  5. Eyelid ptosis;
  6. Myasthenia gravis (from medical history or diseases of neurotransmission);
  7. Current history of facial nerve paralysis;
  8. 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;
  9. Recent flu-like syndrome that, in the investigator's opinion, is severe enough potentially to interfere with subject outcomes;
  10. Neuromuscular disorder that, in the investigator's opinion, is severe enough potentially to interfere with subject outcomes;
  11. Active multisystems disease that, in the investigator's opinion, might influence the outcome measures or the safety of the subject;
  12. 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;
  13. Currently receiving aminoglycoside antibiotic therapy, curare-like drugs, quinidine, succinylcholine, polymyxins, anticholinesterases, magnesium sulfate, or lincosamides;
  14. Has taken any investigational drug during the 30 days prior to screening visit;
  15. Have had Botulinum Toxin treatments to the glabellar and/or forehead area during the 6 months prior to screening visit;
  16. Have had dermal filler treatment to glabellar area during the 6 months prior to screening visit;
  17. 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)
  18. Unwilling or unable to comply with the protocol or to cooperate fully with the investigator and site personnel; and
  19. Unable to understand verbal and/or written English or any other language in which a certified translation of the informed consent document is available.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00752297

Locations
United States, California
Mentor Worldwide, LLC
Santa Barbara, California, United States, 93111
Sponsors and Collaborators
Mentor Worldwide, LLC
Quintiles
Investigators
Study Director: Corey Maas, MD
  More Information

No publications provided

Responsible Party: Mentor Worldwide, LLC
ClinicalTrials.gov Identifier: NCT00752297     History of Changes
Other Study ID Numbers: PT-03a
Study First Received: September 10, 2008
Last Updated: September 1, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Mentor Worldwide, LLC:
Botulinum Toxin Type A
Botulinum Toxin
Glabellar Rhytides
Rhytides
Frown Lines
Neuromuscular Agents
Neurotoxin
Forehead
Eyebrow
Wrinkle

Additional relevant MeSH terms:
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014