A Single-Center, Open-Label, Exploratory Study of the Volumizing Effect of SCULPTRA Measured by Three Dimensional Digital Surface Imaging

Study Overview
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Brief Summary
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Measure the mid-facial volumetric correction from SCULPTRA treatment, using three-dimensional digital surface imaging Determine the mean change from baseline in facial contour deficiency as measured by the Dermik Nasolabial Photo-numeric Scale Correlate volumetric correction with clinical improvement as measured by the Dermik Nasolabial Photo-numeric Scale Correlate the mean volumetric change in mid-facial treatment area with the amount of product used Evaluate subject and investigator global assessment of improvement and subject treatment satisfaction at the end of treatment 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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A Single-Center, Open-Label, Exploratory Study of the Volumizing Effect of Sculptra (Poly-L-lactic Acid) Measured by Three Dimensional Digital Surface Imaging

Conditions
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Mid Facial Contour Deficiencies

Intervention / Treatment
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* Device: DL6049 (injectable poly-L-lactic acid)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must sign a statement of informed consent. Subjects must be 18-75 years of age, of any race or gender. Female patients of childbearing potential must have a negative urine pregnancy test prior to the first treatment with the product and must use an acceptable form of birth control throughout the study (e.g., oral/systemic contraceptives, an intrauterine device (IUD) or Norplant starting at least 28 days prior to study entry and throughout the study). Subjects must display signs of facial contour deficiencies in the area of the nasolabial folds [nasolabial fold scores greater than or equal to 2 (bilaterally) on the Dermik Nasolabial Photo-numeric Scale. Subjects must be a suitable candidate for SCULPTRA treatment. Subjects must be able to understand the requirements of the study and be willing to comply with the study requirements Exclusion Criteria: Subjects with an allergy to any of the constituents of the product. Subjects with a known history of keloids or bleeding disorders. Subjects of childbearing potential who are pregnant, or plan to become pregnant within the study timeframe, or who are nursing. Subjects with significant facial hair (e.g. mustaches, beards, etc.) Subjects with an active inflammatory process or infection in the area to be treated (skin eruptions such as cysts, pimples, rashes, cancerous/pre-cancerous lesions, or any other active skin disease in the treatment area). Subjects who plan to undergo major facial surgery [e.g., rhinoplasty (with or without implant), facelift, congenital defect repair, etc.] during the course of the study. Subjects who have used or plan to use exclusionary medications/treatments.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sculptra<br> | Device: DL6049 (injectable poly-L-lactic acid)<br>* Subjects will be treated with SCULPTRA® every 4-6 weeks in accordance with SCULPTRA® package insert<br>* Other names: Sculptra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the mid-facial volumetric correction from SCULPTRA treatment, using three-dimensional digital surface imaging. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the mean change from baseline in Nasolabial volume as measured by 3-D digital surface imaging |  | 6 months | 
| Correlate volumetric correction with clinical improvement as measured by the Dermik Nasolabial Photo-numeric Scale. |  | 6 months | 
| Correlate the mean volumetric change in mid-facial treatment area with the amount of product used. |  | 6 months | 
| Determine mean change from baseline in the contour deficiency score as determined by the investigator. |  | 6 months | 
| Investigator Global Assessment of Improvement - Excellent Improvement |  | 6 months | 
| Investigator Global Assessment of Improvement - Much Improved |  | 6 Months | 
| Investigator Global Assessment of Improvement - Improved |  | 6 Months | 
| Investigator Global Assessment of Improvement - No Change |  | 6 Months | 
| Investigator Global Assessment of Improvement - Worse |  | 6 Months | 
| Subject Global Assessment of Improvement - Excellent Improvement |  | 6 Months | 
| Subject Global Assessment of Improvement - Much Improved |  | 6 Months | 
| Subject Global Assessment of Improvement - Improved |  | 6 Months | 
| Subject Global Assessment of Improvement - No Change |  | 6 Months | 
| Subject Global Assessment of Improvement - Worse |  | 6 Months |