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Volume Restoration of the Aging Midface With Sculptra Aesthetic

NCT01307865 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2013-10-16

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Williams Center Plastic Surgery Specialists

    lead OTHER

Principal Investigators

  • Edwin F Williams, MD · Williams Center Plastic Surgery Specialists

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-06-30
Completion
2013-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01307865 on ClinicalTrials.gov