Clinical Investigation of the Medical Device "Alexa Volume" for Correction of Midface Volume Loss

This clinical investigation evaluated the effectiveness and safety of the CE-marked medical device "Alexa Volume," a cross-linked hyaluronic acid filler, for correction of midface volume loss in adult subjects. Conducted at multiple centers in Poland and Ukraine, the open-label, non-comparative study collected post-marketing data under routine clinical conditions.

Inclusion criteria

• Twenty-five (25) years of age or older at time of consent.
• Desire and willingness for correction or enhancement of his/her mid-face area.
• Subjects presenting with loss of volume and contour of the midface area 2 or more score according to MMVS bilaterally.
• Nasolabial folds severity grade 2 or more according to WSRS bilaterally.
• Treatment-naive subjects for fillers in the areas to be treated in the last 12 months, otherwise as decided by the Investigator.
• Subjects with signed informed consent and photo consent.
• Medical history and physical examination which, based on the Investigator's opinion, do not prevent the subject from taking part in the investigation and use the investigational medical device (IMD).
• Subjects not pregnant, non-breastfeeding.
• Subject must be willing to complete the entire course of the investigation.

Exclusion criteria

• Pregnant, planning pregnancy during the investigation or breastfeeding women.
• Subjects with known hypersensitivity to any compound of the IMD.
• Subjects with history of any other adverse effect, which could prevent the subject from participating in the investigation according to the Investigator's opinion.
• Any prior surgery, any prior cosmetic procedures or side effects from previous procedures in the injected area, including permanent fillers, that may interfere with the results.
• Subjects with presence of autoimmune disease or other chronic disease that in the opinion of the Investigator may interfere with the outcome of the investigation.
• Subjects with active inflammation or infection in the areas of Alexa administration.
• Subjects with tattoo and/or scar in the area of Alexa Volume administration that in the Investigator's opinion would interfere with investigation assessments.
• Subjects who tend to develop hypertrophic scarring.
• Subjects with impaired hemostatic function, which could prevent the subject from participating in the investigation according to the Investigator's opinion.
• Subjects with fibrosis, birthmark, or residual material in the area of intended use of Alexa Volume.
• Subjects participating in other clinical investigations within 30 days prior to the Visit 1.