Safety and Performance of DKL Crosslinked Sodium Hyaluronate 26 Dermal Filler for Cheek Augmentation

Inclusion criteria

• ✓. Review and sign the Independent Ethics Committee (IEC)-approved Informed Consent Form (ICF) prior to any study-related procedures being performed. In addition, the subject will be asked to provide a separate release for use of their photographs in publications and the clinical investigation report (CIR). The subject has a right to refuse the photo release without jeopardizing their eligibility to participate in the study.
• ✓. Male and female subject aged 18 to 65 years (inclusive) at the time of screening.
• ✓. The subject desires cheek augmentation and/or correction of age-related midface contour deficiencies.
• ✓. Midface with a MMVS score of 3 (moderate loss of fullness with slight hollowing below malar prominence) or 4 (substantial loss of fullness in the midface area, clearly apparent hollowing below malar prominence) on each side of the face as assessed by the blinded evaluator. Both sides of the face should have the same scoring.
• ✓. Female of child-bearing potential (sexually active and not sterile nor postmenopausal for at least 1 year) should have a urine pregnancy test evaluated as negative on the day of enrolment, and agree to use a reliable method of contraception for the duration of the study (effective birth control measures include sexual abstinence, combined \[estrogen and progestogen containing\] hormonal contraception associated with inhibition of ovulation \[oral, intravaginal, transdermal\], progestogen-only hormonal contraception associated with inhibition of ovulation \[oral, injectable, implantable\], intrauterine device \[IUD\] or intrauterine hormone-releasing system \[IUS\] and/or condom with spermicide).
• ✓. Subject agrees to abstain from any facial cosmetic or surgical procedures during the study period.
• ✓. Subject agrees to refrain from excessive weight gain or loss (±10%) during the investigation period.
• ✓. Subject has adequate understanding of the local language to understand verbal and written subject information and is willing to comply with the study requirements.