An Interventional Study to Evaluate the Safety and Performance of Crosslinked Hyaluronic Acid Hydrogel

Exclusion Criteria

• •Presence of recurrent facial/labial herpes;
• •Presence of tendon, bone, or muscular implants near the area of intervention;
• •Subjects previously treated with fillers anywhere in the face or neck;
• •Subjects who have undergone invasive face or neck surgery;
• •Ongoing cutaneous allergies and history of hyper- or hypo-pigmentation in the mouth area, keloid formation, or hypertrophic scarring;
• •Subjects with a known allergy or sensitivity to any component of the investigation products;
• •Subjects with a known allergy or sensitivity to any component of the anesthetic cream;
• •Subjects with active autoimmune disease and subjects immunocompromised or immunosuppressed;
• •Diabetes mellitus or uncontrolled systemic diseases (endocrine, hepatic renal, cardiac, pulmonary, neurological disorder);
• •Problems with coagulation or anti-coagulating therapies in progress;
• •Subjects with acute inflammatory process or infection, active herpes infection, or history of chronic or recurrent infections;
• •Current treatment with substances which act on blood fluidity (eg. Aspirin, NSAIDs, Vitamin E), anti-inflammatory drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment starting more than 1 year ago), drugs able to influence the test results in the investigator opinion;
• •Known drug and/or alcohol abuse;
• •Mental incapacity that precludes adequate understanding or cooperation;
• •Any previous permanent and nonpermanent cutaneous treatment for aesthetic correction e.g. chemical peel, dermabrasion, ablative laser resurfacing, non-invasive skin-tightening, botulinum toxin injections, mesotherapy, or fat injections within 6 months prior to study inclusion;
• •Pregnancy or breastfeeding;
• •COVID-19 vaccination within one month prior to study inclusion;
• •Participation in another investigational study within 1 month prior to study inclusion.