Sculptra for Correction of Midface Volume Deficit and/or Midface Contour Deficiency

Study Overview
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Brief Summary
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This is a randomized, evaluator-blinded, no-treatment controlled study in subjects with Midface Volume Deficit and/or Midface Contour Deficiency.

Detailed Description
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For Group A, after screening, eligible subjects will be treated from day 1 and followed up for 24 months. For Group B, the study includes two phases as follows: Main study phase: It is randomized, evaluator-blinded and no-treatment controlled. After screening, all eligible subjects will be randomized either to the Treatment Group or the Control Group in a 2:1 ratio. All the subjects will be followed up for 12 months. Extension study phase: After the main study phase, the Treatment Group will be followed up for additional 12 months. Each subject assigned to Group A and Treatment Group will receive up to 4 injection sessions with 5(±1) weeks intervals. Subjects assigned to the Control Group will not receive treatment during the study.

Official Title
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A Randomized, Multi-center, Evaluator-blinded, No-treatment Controlled Study to Evaluate the Effectiveness and Safety of Sculptra for Correction of Midface Volume Deficit and/or Midface Contour Deficiency

Conditions
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Midface Volume Deficit

Intervention / Treatment
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* Device: Sculptra


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed and dated informed consent to participate in the study. Men or women aged 18 years of age or older of Chinese origin. Subjects seeking augmentation therapy for the midface. MMVS score of 2, 3 or 4 on each side of the face as assessed by the blinded evaluator. Exclusion Criteria: Known/previous allergy or hypersensitivity to any of the constituents of the product. Known/previous allergy or hypersensitivity to local anaesthetics, e.g. lidocaine or other amide-type anaesthetics. History of severe or multiple allergies, such as anaphylaxis. Previous tissue revitalization treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling or dermabrasion in the area to be treated within 6 months before treatment. Previous surgery (including aesthetic facial surgical therapy or liposuction), piercing or tattoo in the area to be treated. Previous tissue augmentation therapy or contouring with any permanent (non-biodegradable) or semi-permanent filler, autologous fat, lifting threads or permanent implant in the area to be treated. Other condition preventing the subject from entering the study in the Investigator's opinion, e.g. subjects not likely to avoid other facial cosmetic treatments, subjects anticipated to be unreliable, unavailable or incapable of understanding the study assessments or having unrealistic expectations of the treatment result.

Ages Eligible for Study
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Minimum Age: 18 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Each subject assigned to Treatment Group will receive up to 4 injection sessions with 5(±1) weeks intervals. | Device: Sculptra<br>* Initial injection and optional 3 injections with Sculptra in Midface.<br>|
| No Intervention: Control Group<br>Subjects assigned to the Control Group will not receive treatment during the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the percentage of responders | Percentage of responders (defined by at least 1 point improvement on MMVS from baseline on both sides of the face) was measured by blinded evaluator at 12 months. | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PLLA, Midface Volume Deficit