Effectiveness and Safety of Princess FILLER Lidocaine in Correction of Nasolabial Folds (NLF)

Inclusion Criteria

• Male or female subjects, 22 years of age or older, at the Screening visit
• Subjects with two fully visible, approximately symmetrical moderate to severe NLFs (same severity) with severity scores of 2 or 3 on the 5- point NLF-SRS for both NLF as judged by the treating investigator in conjunction with the independent blinded evaluating investigator.
• Females of childbearing potential must have a negative urine pregnancy test at injection visits and must agree to use an adequate method of contraception for the duration of the clinical investigation
• Healthy skin in the nasolabial area and free of diseases that could interfere in cutaneous aging evaluation
• Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of the clinical investigation, including botulinum toxin injections (except glabellar or forehead botulinum toxin treatment)
• Subjects having understood the purpose and conduct of the clinical investigation and having given written informed consent

Exclusion Criteria

• For females: pregnant and/or lactating or planning to become pregnant during the clinical investigation
• History of allergies or hypersensitivity to HA preparations, lidocaine or anesthetics of any amide-based anesthetic
• Since Juvéderm® Ultra XC contains trace amounts of Gram-positive bacterial proteins, subjects with history of allergies to such material can not be included in this clinical investigation
• Tendency to keloid formation, hypertrophic scars and/or pigmentation disorders
• Known human immune deficiency virus-positive individuals
• Presence of infectious, inflammatory or proliferative cancerous or pre-cancerous lesions in the area to be treated
• Re-current herpes simplex in the treatment area
• History or presence of any autoimmune or connective tissue disease, or current treatment with immunomodulating therapy
• Uncontrolled (or instable) diabetes mellitus or systemic diseases
• Facial plastic surgery, tissue augmentation with silicone, fat or another non-absorbable substance (permanent fillers) area of device application
• Implantation of facial dermal fillers in the treatment area in the preceding twelve months
• Skin of the nasolabial region affected by aesthetic treatments (e.g. laser therapy, absorbable and non-absorbable sutures (threads), microneedling and/or botulinum toxin within the last twelve months, dermabrasion and mesotherapy within the last six months, chemical peeling within the last three months) or planning to undergo such procedures during the clinical investigation
• Facial lypolysis, including submental fat treatments, within last month prior to enrollment and during the clinical investigation
• Bariatric surgery within 12 months prior to enrollement and during the clinical investigation
• History of bleeding disorders and/or use of anticoagulant, antiplatelet or thrombolytic medication from ten days pre- to three days post injection
• Planned dental/oral surgery or modification (bridge-work, implants) within two weeks prior injection and to a minimum of four weeks post injection
• Any medical condition prohibiting the inclusion in the clinical investigation according to the judgment of the treating 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
• Any dependency of the subject to the treating investigator, the blinded independent evaluating investigator or clinical investigation site (e.g. employees of the sponsor), or subjects who are employees or relatives of the treating investigator and/or the independent blinded evaluating investigator
• Subjects who have one of the following assessments during the visual examinations at Baseline:

Snellen visual acuity test worse than 20/40 (with corrective eyewear, if appl