Overview

Volume Restoration of the Aging Midface With Sculptra Aesthetic

Status:
Completed
Trial end date:
2013-06-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to examine the effect of Sculptra Aesthetic on the cosmetic rejuvenation of the midface complex. The investigators plan to both qualitatively determine the restoration of midface architecture as well as quantitatively document the change in midface volume by employing three-dimensional (3D) surface imaging which critically analyzes volumetric tissue changes. Our hypothesis is that patients who receive Sculptra Aesthetic injections will experience significant improvement in facial midface volume restoration. - Measure the midfacial volumetric correction from Sculptra Aesthetic treatment, using three-dimensional digital surface imaging - Determine the mean change from baseline in facial contour via quantitative volumetric measurements - Correlate volumetric correction with clinical improvement as measured by the Facial Lipoatrophy Panel grading system - Correlate the mean volumetric change in midfacial treatment area with the amount of product used - Obtain photographs pre- and post-treatment for the purpose of providing a subject visual aid during the course of treatment - Collect safety data
Phase:
Phase 4
Details
Lead Sponsor:
Williams Center Plastic Surgery Specialists
Collaborator:
Sanofi
Treatments:
Mannitol