Volume Restoration of the Aging Midface With Sculptra Aesthetic

Problem of Aging Clinical Trial

Official title:

Volume Restoration of the Aging Midface With Sculptra Aesthetic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01307865
• Other study ID #: EFW-001-SA
• Status: Completed
• Phase: Phase 4
• First received: March 2, 2011
• Last updated: October 13, 2013
• Start date: January 2011
• Est. completion date: June 2013

Study information

• Verified date: October 2013
• Source: Williams Center Plastic Surgery Specialists
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Problem of Aging

Intervention

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.

Locations

Country	Name	City	State
United States	Williams Center Plastic Surgery Specialists	Latham	New York

Sponsors (2)

Lead Sponsor	Collaborator
Williams Center Plastic Surgery Specialists	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Correlate volumetric correction with clinical improvement as measured by the Facial Lipoatrophy Panel grading system		12 mo
Secondary	Correlate the mean volumetric change in midfacial volume with the amount of product used		12 mo
Secondary	Time course and duration of volumetric correction from Sculptra Aesthetic treatment		6 mo
Secondary	Time course and duration of volumetric correction from Sculptra Aesthetic treatment		9 mo
Secondary	Time course and duration of volumetric correction from Sculptra Aesthetic treatment		12 mo
Secondary	Time course and duration of volumetric correction from Sculptra Aesthetic treatment		15 mo