NCT01307865

Volume Restoration of the Aging Midface With Sculptra Aesthetic

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Williams Center Plastic Surgery Specialists · Academic / Other
• Sex: All
• Age: 40 Years – 60 Years
• Healthy volunteers: Accepted

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

Conditions

• Problem of Aging

Interventions

Type	Name	Description
DRUG	injectable poly-L-lactic acid	Each patient will receive up to 1 vial of Sculptra Aesthetic total to both midface complexes at each of 3 treatment sessions, spaced 6 weeks apart.

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-06-01
• Completion: 2013-06-01
• First posted: 2011-03-03
• Last updated: 2013-10-16

Locations

1 site across 1 country: United States