Volume Restoration of the Aging Midface With Sculptra Aesthetic

Phase 4

Completed

• Conditions: Problem of Aging
• Interventions: Drug: injectable poly-L-lactic acid

• Registration Number: NCT01307865
• Lead Sponsor: Williams Center Plastic Surgery Specialists

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-03-02
• Study First Submitted QC: 2011-03-02
• Study First Posted: 2011-03-03
• Primary Completion: 2012-06
• Study Completion: 2013-06
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-13
• Last Update Posted: 2013-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sculptra Aesthetic	injectable poly-L-lactic acid	Patients receiving Sculptra Aesthetic

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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	15 mo

Trial Locations

Locations (1)

Williams Center Plastic Surgery Specialists; 🇺🇸 Latham, New York, United States