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Volume Restoration of the Aging Midface With Sculptra Aesthetic

Sponsor
Williams Center Plastic Surgery Specialists (Other)
Overall Status
Completed
CT.gov ID
NCT01307865
Collaborator
Sanofi (Industry)
15
Enrollment
1
Location
1
Arm
29
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: injectable poly-L-lactic acid
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Volume Restoration of the Aging Midface With Sculptra Aesthetic
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Jun 1, 2012
Actual Study Completion Date :
Jun 1, 2013

Arms and Interventions

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 Aesthetic
  • Sculptra
  • Poly-L-lactic acid

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. Correlate volumetric correction with clinical improvement as measured by the Facial Lipoatrophy Panel grading system [12 mo]

    2. Correlate the mean volumetric change in midfacial volume with the amount of product used [12 mo]

    3. Time course and duration of volumetric correction from Sculptra Aesthetic treatment [6 mo]

    4. Time course and duration of volumetric correction from Sculptra Aesthetic treatment [9 mo]

    5. Time course and duration of volumetric correction from Sculptra Aesthetic treatment [12 mo]

    6. Time course and duration of volumetric correction from Sculptra Aesthetic treatment [15 mo]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Edwin F. Williams, III, M.D., Principal Investigator, Williams Center Plastic Surgery Specialists
    ClinicalTrials.gov Identifier:
    NCT01307865
    Other Study ID Numbers:
    • EFW-001-SA
    First Posted:
    Mar 3, 2011
    Last Update Posted:
    Oct 16, 2013
    Last Verified:
    Oct 1, 2013
    Keywords provided by Edwin F. Williams, III, M.D., Principal Investigator, Williams Center Plastic Surgery Specialists
    midface volume loss
    aging of midface
    sculptra
    sculptra aesthetic
    poly-L-lactic acid
    Additional relevant MeSH terms:
    Mannitol

    Study Results

    No Results Posted as of Oct 16, 2013