Skip to main content
OpenTrials
Completed

NCT Number: NCT01307865

Volume Restoration of the Aging Midface With Sculptra Aesthetic

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Problem of Aging

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Williams Center Plastic Surgery Specialists

Latham, New York, 12110, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

injectable poly-L-lactic acid

Drug

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

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

Sponsors and collaborators

Lead sponsor

Williams Center Plastic Surgery Specialists

Other

Collaborators

  • Sanofi

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Mar 3, 2011
Registry last updated
Oct 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.