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The primary objective of this study involves research to evaluate new collagen (the elastic fibers that provide skin with its strength and resilience) formation in the skin following injections of Sculptra (Poly-L-Lactic Acid or PLLA). The secondary objectives of the study are to better understand the human skin responses to Sculptra and to assess the safety of Sculptra injections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Poly-L-Lactic Acid Injection | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Poly-L-Lactic Acid Injection | Device | 0.05 mL of poly-l-lactic acid will be injected as depot at three (3) points (a total of 0.15 mL). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biopsies change from baseline to 6 months after first Sculptra injection in level of Type 1 collagen. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in level of Type 1 collagen at 3 months and 12 months | 3 and 12 months | |
| Change from baseline in level of Type III collagen at 3 months, 6 months, & 12 months by immunohistochemistry in a central laboratory. | 3, 6, and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Tara Semanchik, MBA | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Laval | Canada |
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| Qualitative assessment in degree of change from baseline in Type I collagen at 3 months, 6 months, & 12 months by a pathologist. | 3, 6, and 12 months |
| Degree of inflammation assessed by histology at 3 months, 6 months, and 12 months. | 3, 6, and 12 months |
| Qualitative assessment in degree of change from baseline in Type III collagen at 3 months, 6 months, & 12 months by a pathologist. | 3, 6, and 12 months |