Safety and Efficacy Study of Repeat Treatment With PurTox® Botulinum Toxin Type A for Frown Lines Between the Eyebrows (PT-03b)

This study has been completed.
Sponsor:
Collaborator:
Synteract, Inc.
Information provided by (Responsible Party):
Mentor Worldwide, LLC
ClinicalTrials.gov Identifier:
NCT00752050
First received: September 11, 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 repeat treatment of an intramuscular dose of Mentor Purified Toxin for the reduction of frown lines, compared with placebo.


Condition Intervention Phase
Glabellar Rhytides
Frown Lines Between the Eyebrows
Drug: Mentor Purified Toxin Botulinum Toxin Type A
Drug: Preservative-free Saline
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 Trial to Demonstrate the Safety and Efficacy of Repeat Treatment With 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:
  • Change in assessments of severity of glabellar rhytide by the investigator and the subject at maximum frown as a single composite effectiveness endpoint. [ Time Frame: Day 30 post randomization ] [ 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:
  • Change in assessments of severity of glabellar rhytide by the investigator and the subject at maximum frown. [ Time Frame: Day 30 post-injection ] [ Designated as safety issue: No ]
  • Change in assessments of severity of glabellar rhytide by the investigator and the subject at rest. [ Time Frame: Day 30 post randomization ] [ Designated as safety issue: No ]
  • Change in assessments of severity of glabellar rhytide by independent reviewers based on the photographs of the subject's glabellar lines at maximum frown. [ Time Frame: Baseline and Day 30 post randomization ] [ Designated as safety issue: No ]

Enrollment: 699
Study Start Date: November 2007
Study Completion Date: March 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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
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.
Other Names:
  • Mentor Purified Toxin Botulinum Toxin Type A
  • Botulinum Toxin Type A
  • Botulinum Toxin
Placebo Comparator: 2
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
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).
Other Names:
  • Preservative-Free Saline
  • Saline

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 in the reduction of glabellar rhytides (frown lines). Approximately 700 subjects will be enrolled at approximately 12 clinical sites in the U.S.A.

Effectiveness 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)

There are two parts to this study. In the first part, all study participants will receive treatment with an intramuscular injection of 30 Units of Mentor Purified Toxin on two separate occasions (Cycles 1 and 2) no more than 6 months apart. In the second part of the study (Cycle 3), subjects will be randomly assigned to receive either intramuscular injections of 30 Units of Mentor Purified Toxin or placebo (preservative-free saline) and subjects will be followed for 1 month (3:1, PurTox : placebo).

Each subject will receive five intramuscular injections for a total of 0.5 mL of study drug in the glabellar area, during each treatment visit. Participation takes place over a maximum of 14 months, including Part 1 (Cycle 1 and 2) and Part 2 (Cycle 3). The number of clinic visits will vary from person to person depending upon the subject's response to the study drug, but will range from approximately 9 to 19 clinic visits. There will also be up to 4 telephone follow-up contacts.

  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. A history of psychiatric problems that, in the investigator's opinion, is severe enough potentially to interfere with subject outcomes;
  2. 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);
  3. 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;
  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 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);
  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: NCT00752050

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

No publications provided

Responsible Party: Mentor Worldwide, LLC
ClinicalTrials.gov Identifier: NCT00752050     History of Changes
Other Study ID Numbers: PT-03b
Study First Received: September 11, 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, Type A
Neuromuscular Agents
Botulinum Toxins
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014