Sponsor business reasons

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

2 years, 9 months (from first subject screening to last subject's last visit).

Groups for each intervention separately cannot be provided since most of the Adverse Events (AEs) are not related to study product. Analysis groups were "Both cheeks group" and "Split-face group" (as presented here). In the Split-face group, only two AEs were assessed as related to study product/device injection procedure: the AE "Implant site pain" which was assessed as related to the HA product under investigation, and the AE "Eye pain" which was not assessed as related to a specific product.