Clinical Study for the Evaluation of the Safety and Effectiveness of Use of a Poly-L Lactic Acid Injectable Filler for the Aesthetic Treatment of Nasolabial Folds

Inclusion Criteria

• Subject with moderate to severe nasolabial folds as determined by a Wrinkle Severity Rating Scale (WSRS) score of 3 or 4 on both folds at the pre-treatment evaluation.
• Subject wiling to abstain from other facial procedures (i.e., dermal fillers, toxin treatments, laser, microdermal abrasion, chemical peels, non-invasive skin-tightening) during the whole study period.
• Subject, psychologically able to understand the study related information and to give a written informed consent.
• Subject having given freely and expressly his/her informed consent.
• Subject willing to have photographs of the face taken.
• Subject affiliated to a health social security system.
• Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks before screening visit and during the whole study period.

Exclusion Criteria

• Pregnant or nursing woman or planning a pregnancy during the study.
• Subject with a scar, moles, pigment disorders or anything on the face which might interfere with the evaluation.
• Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
• Subject in a social or sanitary establishment
• Subject participation to another research on human beings or who is in an exclusion period of one.
• Subject having received 4500 euros indemnities for participation in research involving human beings in the 12 previous months, including participation in the present study.
• Subject suspected to be non-compliant according to the investigator's judgment.
• Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results.
• Subject with known history of or suffering from autoimmune disease and/or immune deficiency.
• Subject suffering from inflammatory and/or infectious cutaneous disorders in or near the studied zones (e.g. acne, mycosis, papilloma, chronic eczema, atopic dermatitis…). Subject with labial herpes in the last 2 years is not eligible even if asymptomatic at time of screening visit.
• Subject with an abscess, unhealed wound, or a cancerous or precancerous lesion on the studied zone.
• Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders.
• Subject with a tendency to develop keloids or hypertrophic scarring.
• Subject having history of allergy or anaphylactic shock including hypersensitivity to Poly-l-lactic acid, to lidocaine or to one of the components of the tested devices or antiseptic solution.
• Subject having received treatment with a laser, a dermabrasion, a surgery, a deep chemical peeling or other ablative procedure on the face within the past 12 months prior to screening visit.
• Subject having received injection with a resorbable filling product in the face area within the past 12 months prior to screening visit.
• Subject having received at any time injection with a slowly resorbable filling product (polylactic acid, calcium hydroxyapatite, combinations of hyaluronic acid (HA) and hypromellose, HA and dextran microbeads or HA and TriCalcium Phosphate (TCP), …) or with a non-resorbable filling product (polyacrylamide, silicone, combination of methacrylic polymers and collagen, polymer particles, …) on the face.
• Subject having received at any time a treatment with tensor threads on the face.
• Subject having started or changed her oral contraceptive or any other hormonal treatment during 12 weeks prior to screening visit.
• Subject using medication such as aspirin, nonsteroidal anti-inflammatory drugs (NSAID) (ibuprofen, naproxen, …), antiplatelet agents, anticoagulants or other substances known to prolong bleeding time within 1 week prior to injection visits.
• Subject undergoing a topical treatment on the test area or a systemic treatment:
• Antihistamines during the 2 weeks prior to screening visit.
• Immunosuppressors and/or corticoids during the 4 weeks prior to scre