Safety and Effectiveness of THIODERM STRONG in the Correction of Nasolabial Folds

A Prospective, Open Label, Dose-escalating, Multicenter Clinical Investigation to Evaluate the Safety and Effectiveness of THIODERM STRONG in the Correction of Nasolabial Folds.

This is a prospective, open label, dose-escalating, multicenter clinical investigation to evaluate the safety and effectiveness of THIODERM STRONG in the correction of nasolabial folds.

The performance is assessed using the 5-point Nasolabial Folds Severity Rating Scale (NLF-SRS) at Week 12 compared to baseline.

Inclusion Criteria:

• Females of childbearing potential must have a negative urine pregnancy test at Screening/ Baseline visit and must agree to use an adequate method of contraception for the duration of the clinical investigation
• Signed informed consent
• Moderate to severe nasolabial folds (cohort 2)
• Healthy skin in the nasolabial area and free of diseases that could interfere in cutaneous aging evolution (cohort 2)
• Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of the clinical investigation

Exclusion Criteria:

• For females: pregnant and/ or lactating or planning to become pregnant during the investigation
• History of allergies or hypersensitivity to hyaluronic acid preparations, lidocaine or any amide-basede anesthetic
• Tendency to keloid formation and/ or hypertrophic scars
• Presence of infectious, inflammatory or proliferative cancerous or pre-cancerous lesions in the area to be treated
• Recurrent herpes simplex in the treatment area
• History or presence of any autoimmune or connective tissue disease, or current treatment with immunomodulating therapy
• Diabetes mellitus or uncontrolled systemic diseases
• History of bleeding disorder and/ or use of anticoagulant, antiplatelet or thrombolytic medication from ten days pre- to three days post-injection
• Any medical condition prohibiting the inclusion in the clinical investigation according to the judgment of the investigator
• Previous enrollment in this clinical investigation
• Current participation in another clinical investigation, or treatment with any investigational drug/ medical device within 30 days prior to clinical investigation enrollment, or five half-lives of the investigational drug, whichever is longer
• Any dependency of the subject to the investigator or investigation site, or subjects who are employees or relatives of the investigator
• Subjects whose participation in clinical investigations is prohibited by the Austrian Medical Devices Act
• Facial plastic surgery, tissue augmentation with silicone, fat or another non-absorbable substance in the area of device application (cohort 2)
• Implantation of facial dermal fillers in the treatment area in the preceding 12 months (cohort 2)
• Skin of the nasolabial region affected by aesthetic treatments or planning to undergo such procedures during the clinical investigation (cohort 2)
• Facial lipolysis, including submental fat treatments within last month prior to enrollment or planned during the clinical investigation (cohort 2)
• Bariatric surgery within 12 months prior to enrollment or planned during the clinical investigation (cohort 2)
• Planned dental/ oral surgery or modification within two weeks prior to injection and to a minimum of four weeks post injection (cohort 2)