Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-27 @ 9:45 PM
Study NCT ID:
NCT00752050
Status:
COMPLETED
Last Update Posted:
2011-09-12
First Post:
2008-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of Repeat Treatment With PurTox® Botulinum Toxin Type A for Frown Lines Between the Eyebrows
Sponsor:
Mentor Worldwide, LLC
Organization:
Study Overview
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")
Status:
COMPLETED
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PT-03b
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: