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CompletedNCT01307865Updated Oct 16, 2013

Volume Restoration of the Aging Midface With Sculptra Aesthetic

A Phase 4 interventional study of injectable poly-L-lactic acid in Problem of Aging, sponsored by Williams Center Plastic Surgery Specialists. Completed at 1 site in United States. Open to participants aged 40 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-10-16.

Sponsored by Williams Center Plastic Surgery Specialists · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
40 Years to 60 Years
Sex
All
01

Study 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
02

Conditions studied

  • Problem of Aging

Keywords

  • midface volume loss
  • aging of midface
  • sculptra
  • sculptra aesthetic
  • poly-L-lactic acid
03

In context

Lead sponsor

This is the only study on the registry with Williams Center Plastic Surgery Specialists as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age 40-60 years old
  • BMI greater than 18.5 and less than 24.9

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Sculptra Aesthetic

    Patients receiving Sculptra Aesthetic

    Drug: injectable poly-L-lactic acid

Interventions

  • Druginjectable 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.

    Also known as: Sculptra Aesthetic, Sculptra, Poly-L-lactic acid

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: 12 mo

  2. Correlate the mean volumetric change in midfacial volume with the amount of product used

    Time frame: 12 mo

  3. Time course and duration of volumetric correction from Sculptra Aesthetic treatment

    Time frame: 6 mo

  4. Time course and duration of volumetric correction from Sculptra Aesthetic treatment

    Time frame: 9 mo

  5. Time course and duration of volumetric correction from Sculptra Aesthetic treatment

    Time frame: 12 mo

  6. Time course and duration of volumetric correction from Sculptra Aesthetic treatment

    Time frame: 15 mo

07

Study locations

1 site
  • Williams Center Plastic Surgery Specialists
    Latham, New York 12110, United States
08

References and documents

Publications

  • 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. PubMed 25340593 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 16, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01307865
Lead sponsor
Williams Center Plastic Surgery Specialists
Collaborators
Sanofi
Responsible party
Edwin F. Williams, III, M.D. (Principal Investigator, Williams Center Plastic Surgery Specialists) — Principal investigator
First posted
Mar 3, 2011
Start date
Jan 2011
Primary completion
Jun 2012
Completion
Jun 2013
Last update
Oct 16, 2013

Study contacts

Edwin F Williams, MD
principal investigator · Williams Center Plastic Surgery Specialists
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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