Problem of Aging
Conditions
Keywords
midface volume loss, aging of midface, sculptra, sculptra aesthetic, poly-L-lactic acid
Brief 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
Interventions
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
Sanofi
Williams Center Plastic Surgery Specialists
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 40-60 years old * BMI greater than 18.5 and less than 24.9
Exclusion criteria
* Age less than 40 years or greater than 60 years * Prior surgical or non-surgical treatment to the midface within the past 2 years * Interested in seeking other treatments to the midface during the study period * Pregnant, lactating, or breast feeding * Hypersensitivity to poly-L-lactic acid, carboxymethylcellulose, or mannitol * Allergy to lidocaine or epinephrine * History of atopy, anaphylaxis, or multiple severe allergies * Current immunotherapy or history of autoimmune disease * History of or active stroke or myocardial infarction * History of or active connective tissue disease * History of or active bleeding disorders * History of or active cancer * Serious abnormalities in laboratory findings * Active hepatitis * Active infection or inflammatory process of skin * History of or risk factors for hypertrophic scarring or keloid formation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in midfacial volume from Sculptra Aesthetic treatment, using three-dimensional digital surface imaging | 6 mo, 9 mo, 12 mo, 15 mo |
Secondary
| Measure | Time frame |
|---|---|
| Correlate volumetric correction with clinical improvement as measured by the Facial Lipoatrophy Panel grading system | 12 mo |
| Correlate the mean volumetric change in midfacial volume with the amount of product used | 12 mo |
| Time course and duration of volumetric correction from Sculptra Aesthetic treatment | 6 mo |
Countries
United States
Outcome results
None listed