Volume Restoration of the Aging Midface With Sculptra Aesthetic

NCT ID: NCT01307865

Last Updated: 2013-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-06-30

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

Conditions

Problem of Aging

Keywords

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sculptra Aesthetic

Patients receiving Sculptra Aesthetic

Group Type: EXPERIMENTAL

injectable poly-L-lactic acid

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Sculptra Aesthetic; Sculptra; Poly-L-lactic acid

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Williams Center Plastic Surgery Specialists

OTHER

Sponsor Role: lead

Responsible Party

Edwin F. Williams, III, M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edwin F Williams, MD

Role: PRINCIPAL_INVESTIGATOR

Williams Center Plastic Surgery Specialists

Locations

Williams Center Plastic Surgery Specialists

Latham, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25340593 (View on PubMed)

Other Identifiers

EFW-001-SA

Identifier Type: -

Identifier Source: org_study_id