Evaluation of Efficacy and Safety of Hyaluronic Acid (HA) Product for Cheek Augmentation

Study Overview
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Brief Summary
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A multi-centre, evaluator-blinded study in subjects undergoing cheek augmentation. The study is designed to assess efficacy with regard to aesthetic midface augmentation and safety after treatment with HA product.

Official Title
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A Multi-Centre, Evaluator-Blinded Study to Evaluate Efficacy and Safety of R Volumizer for Cheek Augmentation

Conditions
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Facial Tissue Augmentation

Intervention / Treatment
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* Device: HA experimental
* Device: HA comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide a signed and dated informed consent to participate in the study including release of copyright of images Man or woman aged 18 years or older Be willing to abstain from any other facial plastic surgical or cosmetic procedures in close proximity to the treated area Exclusion Criteria: Known/previous allergy or hypersensitivity to any injectable HA gel History of bleeding disorder or treatment with anticoagulants, thrombolytics, or inhibitors of platelet aggregation, omega-3, or vitamin E within 2 weeks before treatment Treatment with chemotherapy, immunosuppressive agents, immunomodulatory therapy, topical retinoids, systemic or topical corticosteroids within 3 months before treatment and systemic retinoids within 6 months before treatment Previous tissue augmenting therapy or contouring with permanent filler, fat-injection or permanent implant placed in the area to be treated The subject is, in the opinion of the investigator, unlikely to comply with the clinical investigational plan or is unsuitable for any other reason

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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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HA experimental<br>HA experimental only | Device: HA experimental<br> <br> |
| Active Comparator: HA comparator<br>HA experimental + HA comparator | Device: HA experimental<br> <br> Device: HA comparator<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Responders in Midface Fullness Using Photo Scale | Evaluation of midface fullness, determined by the percentage of responders at 3 months after last treatment, in both cheeks, derived from the Blinded Evaluator's live assessment of a validated photo scale. A responder was defined as a subject with ≥1 grade improvement from baseline in both cheeks. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Responders in Midface Fullness Using Photo Scale | Evaluate midface fullness as determined by percentage of responders at 4 weeks and 6, 9, 12 and, if applicable, 15 months after last treatment as well as 4 weeks and 3 months after re-treatment, derived from the Blinded Evaluator's live assessment of photo scale. A responder was defined as a subject with ≥1 grade improvement from baseline in both cheeks. | 15 months |