Safety and Efficacy Study of Repeat Treatment With PurTox® Botulinum Toxin Type A for Frown Lines Between the Eyebrows (PT-03b)
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|ClinicalTrials.gov Identifier: NCT00752050|
Recruitment Status : Completed
First Posted : September 15, 2008
Last Update Posted : September 12, 2011
|Condition or disease||Intervention/treatment||Phase|
|Glabellar Rhytides Frown Lines Between the Eyebrows||Drug: Mentor Purified Toxin Botulinum Toxin Type A Drug: Preservative-free Saline||Phase 3|
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:
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||699 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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")|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||March 2009|
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.
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 Name: Saline
- 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 ]
- Measurement of the incidences of treatment-emergent adverse events, serious treatment-emergent adverse events, treatment-emergent laboratory abnormalities, and vital signs. [ Time Frame: Throughout ]
- Change in assessments of severity of glabellar rhytide by the investigator and the subject at maximum frown. [ Time Frame: Day 30 post-injection ]
- Change in assessments of severity of glabellar rhytide by the investigator and the subject at rest. [ Time Frame: 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. [ Time Frame: Baseline and Day 30 post randomization ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00752050
|United States, California|
|Mentor Wordwide, LLC|
|Santa Barbara, California, United States, 93111|
|Study Director:||Corey Maas, MD|