NCT01307865

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 3, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

October 16, 2013

Status Verified

October 1, 2013

Enrollment Period

1.4 years

First QC Date

March 2, 2011

Last Update Submit

October 13, 2013

Conditions

Problem of Aging

Keywords

midface volume lossaging of midfacesculptrasculptra aestheticpoly-L-lactic acid

Outcome Measures

Primary Outcomes (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 Outcomes (6)

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

    12 mo

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

    12 mo

  • Time course and duration of volumetric correction from Sculptra Aesthetic treatment

    6 mo

  • Time course and duration of volumetric correction from Sculptra Aesthetic treatment

    9 mo

  • Time course and duration of volumetric correction from Sculptra Aesthetic treatment

    12 mo

  • +1 more secondary outcomes

Study Arms (1)

Sculptra Aesthetic

EXPERIMENTAL

Patients receiving Sculptra Aesthetic

Drug: injectable poly-L-lactic acid

Interventions

injectable poly-L-lactic acidDRUG

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
Sculptra Aesthetic

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Williams Center Plastic Surgery Specialists

Latham, New York, 12110, United States

Location

Related Publications (1)

  • 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.

    PMID: 25340593DERIVED

MeSH Terms

Interventions

New-Fillpoly(lactide)

Study Officials

  • Edwin F Williams, MD

    Williams Center Plastic Surgery Specialists

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 2, 2011

First Posted

March 3, 2011

Study Start

January 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2013

Last Updated

October 16, 2013

Record last verified: 2013-10

Locations

US(1)