Clinical trial NCT01307865: Volume Restoration of the Aging Midface With Sculptra Aesthetic
Official title: Volume Restoration of the Aging Midface With Sculptra Aesthetic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Problem of Aging
Keywords: midface volume loss
aging of midface
sculptra
sculptra aesthetic
poly-L-lactic acid
Lead sponsor: Williams Center Plastic Surgery Specialists
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2011-03-03
Enrollment: 15
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in midfacial volume from Sculptra Aesthetic treatment, using three-dimensional digital surface imaging
timeFrame: 6 mo, 9 mo, 12 mo, 15 mo
Secondary outcomes:
measure: Correlate volumetric correction with clinical improvement as measured by the Facial Lipoatrophy Panel grading system
timeFrame: 12 mo
measure: Correlate the mean volumetric change in midfacial volume with the amount of product used
timeFrame: 12 mo
measure: Time course and duration of volumetric correction from Sculptra Aesthetic treatment
timeFrame: 6 mo
measure: Time course and duration of volumetric correction from Sculptra Aesthetic treatment
timeFrame: 9 mo
measure: Time course and duration of volumetric correction from Sculptra Aesthetic treatment
timeFrame: 12 mo
measure: Time course and duration of volumetric correction from Sculptra Aesthetic treatment
timeFrame: 15 mo
Other outcomes:
Locations:
city: Latham
country: United States
facility: Williams Center Plastic Surgery Specialists
state: New York
Study officials:
affiliation: Williams Center Plastic Surgery Specialists
name: Edwin F Williams, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen HH, Javadi P, Daines SM, Williams EF 3rd. Quantitative assessment of the longevity of poly-L-lactic acid as a volumizing filler using 3-dimensional photography. JAMA Facial Plast Surg. 2015 Jan-Feb;17(1):39-43. doi: 10.1001/jamafacial.2014.867.