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Primary:
Evaluate the degree of correction attainable with Poly-L-Lactic Acid(Sculptra) for the correction of hill and valley acne scarring
Secondary:
Document types and incidence of device adverse events with Poly-L-Lactic Acid(Sculptra) therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | single arm study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sculptra (Poly-L-Lactic Acid Dermal Implant) | Device | Drug Device study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physician Scar Improvement Scale (PSIS) | At each visit | |
| Self-Assessed Scar Improvement Scale (SASIS). | At each visit |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of subject satisfaction with treatment | At each Visit | |
| Adverse events | At each visit |
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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 |
|---|---|---|
| Mary Tzortzis | Sanofi-Aventis Canada Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Laval | Canada |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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