Volume Restoration of the Aging Midface With Sculptra Aesthetic

October 13, 2013 updated by: Edwin F. Williams, III, M.D., Williams Center Plastic Surgery Specialists

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Latham, New York, United States, 12110
        • Williams Center Plastic Surgery Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Sculptra Aesthetic
Patients receiving Sculptra Aesthetic
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.
Other Names:
  • Sculptra
  • Sculptra Aesthetic
  • Poly-L-lactic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in midfacial volume from Sculptra Aesthetic treatment, using three-dimensional digital surface imaging
Time Frame: 6 mo, 9 mo, 12 mo, 15 mo
6 mo, 9 mo, 12 mo, 15 mo

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlate volumetric correction with clinical improvement as measured by the Facial Lipoatrophy Panel grading system
Time Frame: 12 mo
12 mo
Correlate the mean volumetric change in midfacial volume with the amount of product used
Time Frame: 12 mo
12 mo
Time course and duration of volumetric correction from Sculptra Aesthetic treatment
Time Frame: 6 mo
6 mo
Time course and duration of volumetric correction from Sculptra Aesthetic treatment
Time Frame: 9 mo
9 mo
Time course and duration of volumetric correction from Sculptra Aesthetic treatment
Time Frame: 12 mo
12 mo
Time course and duration of volumetric correction from Sculptra Aesthetic treatment
Time Frame: 15 mo
15 mo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Williams Center Plastic Surgery Specialists

Collaborators

Sanofi

Investigators

  • Principal Investigator: Edwin F Williams, MD, Williams Center Plastic Surgery Specialists

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

March 2, 2011

First Submitted That Met QC Criteria

March 2, 2011

First Posted (ESTIMATE)

March 3, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

October 16, 2013

Last Update Submitted That Met QC Criteria

October 13, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFW-001-SA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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