Safety and Performance of Princess® VOLUME for the Treatment of Facial Lipoatrophy, Asymmetry or Scars

Exclusion Criteria

• •Pregnancy, breastfeeding, or unwillingness to use contraception throughout the clinical investigation (for women of child-bearing potential only)
• •History of allergic reaction or hypersensitivity to hyaluronic acid
• •History or presence of any autoimmune or connective tissue disease, or current treatment with immune therapy
• •Presence of silicone implant or other non-absorbable tissue filler in the area targeted for intervention, or pre-treatment with any hyaluronic acid filler within the last six months
• •Presence of infectious, inflammatory, or proliferative lesions in the area targeted for intervention
• •Treatment with anticoagulant or antiplatelet drugs
• •Any disease or condition which, in the Investigator's opinion, represents a safety risk for participation in the study
• •Current participation in another clinical trial, or previous treatment with any investigational drug/device within 30 days prior to enrolment
• •Institutionalized persons with legally limited civil rights