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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sculptra Aesthetic | Experimental | Patients receiving Sculptra Aesthetic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| injectable poly-L-lactic acid | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edwin F Williams, MD | Williams Center Plastic Surgery Specialists | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Williams Center Plastic Surgery Specialists | Latham | New York | 12110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25340593 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 2, 2016 | |
| Reset | Feb 29, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 2, 2016 | Feb 29, 2016 |
| ID | Term |
|---|---|
| C482305 | New-Fill |
| C033616 | poly(lactide) |
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|
| 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 |