THIODERM ELATE for Volume Augmentation in Lips

Exclusion criteria

• ✕. Females, who are pregnant and/or, lactating or planning to become pregnant during the clinical investigation.
• ✕. History of allergy or hypersensitivity to hyaluronic acid preparations, lidocaine or any amide-based anesthetic.
• ✕. Prior surgery, scars or tattoo to the upper or lower lip or lip line; surgery and tattooing are prohibited until end of clinical investigation.
• ✕. Tooth gap, overbite, beard longer three-day beard, or excessive facial hair that could interfere in evaluation of treatment as judged by the treating investigator.
• ✕. Presence of any abnormal lip structure, such as a scar or lump or severe lip asymmetry, as judged by the treating investigator.
• ✕. Presence of infectious, inflammatory or proliferative cancerous or pre-cancerous lesions in the treatment area.
• ✕. Re-current (at least three times over the last year) herpes simplex in the treatment area.
• ✕. History or presence of the following autoimmune or connective tissue diseases: Scleroderma, advanced Lupus erythematosus that is unstable, acute rheumatic fever with heart complications.