Volume Restoration of the Aging Midface With Sculptra Aesthetic

Study Overview
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Brief Summary
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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

Official Title
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Volume Restoration of the Aging Midface With Sculptra Aesthetic

Conditions
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Problem of Aging

Intervention / Treatment
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* Drug: injectable poly-L-lactic acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sculptra Aesthetic<br>Patients receiving Sculptra Aesthetic | Drug: injectable poly-L-lactic acid<br>* 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.<br>* Other names: Poly-L-lactic acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Time course and duration of volumetric correction from Sculptra Aesthetic treatment |  | 15 mo | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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midface volume loss, aging of midface, sculptra, sculptra aesthetic, poly-L-lactic acid