A Long-Term Safety Study of Repeat Treatment With PurTox® for Frown Lines Between the Eyebrows — PT-03c  

Glabellar Rhytides Clinical Trial

Official title: A Phase III, Multi-Center, Long-Term, Repeat-Treatment, Open-Label, Single-Arm Trial to Demonstrate the Safety of Repeat Treatment With PurTox® for the Treatment of Glabellar Rhytides ("Frown Lines")

Status Completed

Clinical Trial Summary

The overall purpose of this study is to evaluate the long-term safety of repeat treatment with an intramuscular dose of Mentor Purified Toxin for the reduction of frown lines.

Clinical Trial Description

This is a Phase III, multi-center, open-label study to evaluate the long-term safety of repeat treatment with PurTox for the treatment of glabellar rhytides. Up to 576 patients will be enrolled at 12 sites in the U.S.A. and some of these patients may have participated in Mentor Purified Toxin Phase I, II and IIIa studies. Safety and tolerability of the repeat treatment with Mentor Purified Toxin will be examined during the study.

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)

All subjects meeting the study eligibility criteria will be treated with 30 U of Mentor Purified Toxin. Following the treatment, follow-up assessments are scheduled as follows: telephone safety assessments on post-treatment Days 7 and 14, a clinic visit on post-treatment Day 30, and a telephone safety assessment on post-treatment Day 60 and monthly thereafter until re-treatment.

A subject will be re-treated when he/she attains grade 2 (Moderate) or 3 (Severe) in the investigator's and subject's ratings of the severity of glabellar rhytides at maximum frown on a 4-point categorical scale, but not earlier than 90 days following the prior treatment. The subject will call the site when he/she rates the glabellar rhytides as grade 2 or 3 in severity to schedule an appointment for re-evaluation and possible re-treatment. The appointment must occur within 2 weeks of the subject's call but not earlier than 90 days post the previous injection. If at the clinic visit the subject's glabellar rhytides are graded by the investigator as grade 2 or 3 in severity and other eligibility criteria are met (e.g., negative urine pregnancy test in female subjects of childbearing potential), the subject will be re-treated. If a subject is eligible for re-treatment on or before 90 days post the previous injection, he/she will receive treatment of Mentor Purified Toxin on or after 90 days. If a subject is not eligible for re-treatment at 90 days, he/she can return to the clinic monthly until attaining grade 2 (Moderate) or 3 (Severe) in the investigator's and subject's ratings of the severity of glabellar rhytides at maximum frown on a 4-point categorical scale, at which time he/she will receive another treatment of Mentor Purified Toxin.

If a subject chooses not to be re-treated with Mentor Purified Toxin when he/she becomes eligible for re-treatment, the subject will be followed up with the monthly telephone safety assessments and annual safety visits to the clinic. It is anticipated that most subjects will receive multiple repeat treatments during this study. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glabellar Rhytides

• NCT number: NCT00752258
• Study type: Interventional
• Source: Mentor Worldwide, LLC
• Status: Completed
• Phase: Phase 3
• Start date: February 2008
• Completion date: May 2011