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To assess protein expression stimulated by poly L-lactic acid (PLLA) via punch biopsy at each follow-up visits compared to Baseline.
This is a randomized, prospective study. This study will enroll approximately 40 subjects across two sites. All subjects have moderate-to-severe cheek wrinkles on both cheeks.
Eligible subjects will first receive punch biopsy on one pre-auricular side according to a pre-determined randomization, followed by a first Sculptra treatment on both cheeks starting at the pre-auricular areas first at Baseline visit. Subjects will receive second Sculptra treatment at Week 4, and an optional third treatment at Week 8. At 12 weeks since last Sculptra treatment, half of the subjects will receive a second punch biopsy on the other pre-auricular side (per randomization). Subjects will have a follow up visit at 24 weeks since last Sculptra treatment. At 36 weeks since last Sculptra treatment, the remaining half will receive a second punch biopsy on the other pre-auricular side (per randomization).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | All subjects have moderate-to-severe cheek wrinkles and will be treated with Sculptra three times, 4 weeks apart. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sculptra® | Device | Biostimulator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Protein Expression | Punch biopsies will be performed at the pre-auricular areas. Histology staining or immunohistochemistry will be performed on punch biopsy samples to evaluate targeted biomarkers compared to Baseline. | 12 weeks, 24 weeks, and 36 weeks after Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Subject satisfaction using self-assessment questionnaire | Subjects will be asked about their perception and satisfaction with the study treatments using a self-assessment questionnaire at visits after Baseline. The questionnaire will be a 5-point subject satisfaction questionnaire with the following responses: strongly agree, agree, neither agree nor disagree, disagree, strongly disagree. | 12 weeks, 24 weeks, and 36 weeks since final Sculptra treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Dermatology & Laser Institute | Recruiting | Miami | Florida | 33133 | United States |
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| Day Dermatology & Aesthetics | Recruiting | New York | New York | 10021 | United States |
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