Open Label Extension for 43USSA1812

Study Overview
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Brief Summary
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To evaluate long-term safety and effectiveness data of Sculptra Aesthetic beyond the Month 12 duration of the pivotal study 43USSA1812 (NCT04124692) to help characterize the long-term safety and effectiveness profile of the more dilute suspension.

Official Title
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Open Label Extension for 43USSA1812 (A Randomized, Evaluator-blinded, No-treatment Controlled, Multi-center Study to Evaluate the Effectiveness and Safety of Sculptra Aesthetic for Correction of Cheek Wrinkles)

Conditions
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Cheek, Wrinkle

Intervention / Treatment
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* Device: Sculptra Aethestic reconsituted with 8ml Sterile Water for Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject completed Month 12 of study 43USSA1812 Subjects willing to comply with the requirements of the extension of the study and providing a signed written informed consent. Exclusion Criteria: 1. For subjects eligible for treatment in the extension study, the exclusion criteria for study 43USSA1812 applies.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Subjects originally randomized to Control Group at baseline in the pivotal 43USSA1812 study will be offered treatment with Sculptra Aesthetic in the extension study. Subjects originally randomized to Treatment Group at baseline in the pivotal 43USSA1812 study will be continued to be followed up during the extension study without further treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Treatment Group in pivotal study<br>followed for long-term safety and effectiveness with no additional treatment | |
| Experimental: Control Group in the pivotal study<br>receiving treatment in the extension study | Device: Sculptra Aethestic reconsituted with 8ml Sterile Water for Injection<br>* Sculptra Aesthetic 8ml and Lidocaine treatment of cheek wrinkles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder rate for a single regimen of Sculptra Aesthetic in the correction of cheek wrinkles | A responder is defined as a subject with at least 1 grade improvement from pre-treatment on both cheeks concurrently | Month 19 | 
| Responder rate for a single regimen of Sculptra Aesthetic in the correction of cheek wrinkles | A responder is defined as a subject with at least 1 grade improvement from pre-treatment on both cheeks concurrently | Month 21 | 
| Responder rate for a single regimen of Sculptra Aesthetic in the correction of cheek wrinkles | A responder is defined as a subject with at least 1 grade improvement from pre-treatment on both cheeks concurrently | Month 24 |