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Mentor Completes first of three trials for PurTox

Article-Mentor Completes first of three trials for PurTox

Santa Barbara, Calif. - Mentor Corp. recently announced completing the first of three Phase 3 clinical trials of its botulinum neurotoxin, PurTox, for the reduction of glabellar rhytids, reports Medical News Today.

During the trial, 400 subjects at 10 U.S. sites received a single treatment with either PurTox or placebo. At designated points over six months, subjects, investigators and independent reviewers used a 4-point photo scale as a reference to score reduction in line severity. Outcome satisfaction was measured using a standard assessment tool, and safety was assessed by adverse event tracking. The results for the primary efficacy endpoint and for each of the eight secondary efficacy endpoints were all indicative of a substantial treatment effect. In addition, a very large percentage of subjects expressed a high degree of satisfaction with treatment outcome.

The remaining two Phase 3 studies have completed enrollment. Data from all three studies will be used to support the filing of a Biologics License Application with the FDA.

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