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

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

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.

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