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Volume Restoration of the Aging Midface With Sculptra Aesthetic

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Williams Center Plastic Surgery Specialists.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Sanofi
Information provided by:
Williams Center Plastic Surgery Specialists
ClinicalTrials.gov Identifier:
NCT01307865
First received: March 2, 2011
Last updated: April 28, 2011
Last verified: February 2011
History of Changes
  Purpose

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

Condition Intervention Phase
Problem of Aging
 Drug: injectable poly-L-lactic acid
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Volume Restoration of the Aging Midface With Sculptra Aesthetic

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Williams Center Plastic Surgery Specialists:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlate volumetric correction with clinical improvement as measured by the Facial Lipoatrophy Panel grading system [ Time Frame: 12 mo ] [ Designated as safety issue: No ]
  • Correlate the mean volumetric change in midfacial volume with the amount of product used [ Time Frame: 12 mo ] [ Designated as safety issue: No ]
  • Time course and duration of volumetric correction from Sculptra Aesthetic treatment [ Time Frame: 6 mo ] [ Designated as safety issue: No ]
  • Time course and duration of volumetric correction from Sculptra Aesthetic treatment [ Time Frame: 9 mo ] [ Designated as safety issue: No ]
  • Time course and duration of volumetric correction from Sculptra Aesthetic treatment [ Time Frame: 12 mo ] [ Designated as safety issue: No ]
  • Time course and duration of volumetric correction from Sculptra Aesthetic treatment [ Time Frame: 15 mo ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: January 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Aesthetic
  • Sculptra
  • Poly-L-lactic acid

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01307865

Locations
United States, New York
Williams Center Plastic Surgery Specialists
Latham, New York, United States, 12110
Sponsors and Collaborators
Williams Center Plastic Surgery Specialists
Sanofi
Investigators
Principal Investigator: Edwin F Williams, MD Williams Center Plastic Surgery Specialists
  More Information

No publications provided

Responsible Party: Edwin F. Williams, MD, Williams Center Plastic Surgery Specialistis
ClinicalTrials.gov Identifier: NCT01307865     History of Changes
Other Study ID Numbers: EFW-001-SA
Study First Received: March 2, 2011
Last Updated: April 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Williams Center Plastic Surgery Specialists:
midface volume loss
aging of midface
sculptra
sculptra aesthetic
poly-L-lactic acid

ClinicalTrials.gov processed this record on May 16, 2013