Protocol for the Post-approval Study of ArteFill® for Correction of Nasolabial Folds

Nasolabial Folds Clinical Trial

Official title: Protocol for the Post-approval Study of ArteFill® for Correction of Nasolabial Folds

Status Completed

Clinical Trial Summary

The purpose of this post-approval study is to evaluate the continuing safety of ArteFill as an injectable implant for correction of nasolabial folds over the course of five years post implantation, with a focus on determining the incidence of granuloma formation. Incidence of adverse events and subject satisfaction with respect to the subject's personal expectations will be assessed.

Clinical Trial Description

This study is a multi-center, non-randomized, non-controlled post-approval study designed to follow a total of 1000 consecutive qualified and consenting subjects treated with ArteFill in the course of clinical practice at approximately twenty-five centers. All potential qualifying subjects at a given site should be given the opportunity to participate in the study. Inclusion and exclusion criteria will be limited to those in the approved labeling for ArteFill and treatment will be according to the approved product labeling. Subjects must have a previously documented negative skin test prior to treatment. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Nasolabial Folds

• NCT number: NCT00778531
• Study type: Interventional
• Source: Suneva Medical, Inc.
• Status: Completed
• Phase: Phase 4
• Start date: September 2007
• Completion date: February 2014