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

Glabellar Rhytides Clinical Trial

— PT-03a  

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")

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00752297
• Other study ID #: PT-03a
• Status: Completed
• Phase: Phase 3
• First received: September 10, 2008
• Last updated: September 1, 2011
• Start date: June 2007
• Est. completion date: May 2008

Study information

• Verified date: September 2011
• Source: Mentor Worldwide, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 402
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glabellar Rhytides

Intervention

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).
• 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.

Locations

Country	Name	City	State
United States	Mentor Worldwide, LLC	Santa Barbara	California

Sponsors (2)

Lead Sponsor	Collaborator
Mentor Worldwide, LLC	Quintiles, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Measurement of the incidences of treatment-emergent adverse events, serious treatment-emergent adverse events, treatment-emergent laboratory abnormalities, and vital signs.		Throughout	Yes
Secondary	Degree of glabellar rhytide reduction assessed by the investigator and the subject at maximum frown.		Days 3, 7 and 30 post-injection	No
Secondary	Degree of glabellar rhytide reduction assessed by the investigator and the subject at rest.		Day 30 Post-injection	No
Secondary	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	No
Secondary	Explore the global satisfaction of the subject with the treatment.		Day 30 post-injection	No