Evaluation of Anti-aging Performance and Tolerance of a Hyaluronic Acid-based Filler NCTF135HA®

The NCTF135HA medical device from Laboratoires FILL-MED by FILORGA Company is an injectable solution for the treatment of wrinkles and biorevitalization of injected mature skin using a multi-injection technique with CE marking. It is a viscoelastic injectable solution of 1% hyaluronic acid (10mg/ml), non-crosslinked of non-animal origin, obtained by biofermentation, resorbable, opalescent, sterile and apyrogenic. NCTF135HA is an anti-aging viscoelastic solution for the revitalization and intense hydration of tired or dull skin, the treatment of wrinkles and the redensification of mature or sagging skin. This hyaluronic acid solution is intended to be injected into the superficial dermis to compensate for the loss of moisture. Given the expected impact of the injection procedure of the biorevitalization solution on wrinkles, the primary endpoint was chosen to evaluate the effectiveness of the treatment on wrinkles.

Inclusion Criteria:Male or female subjects ≥19 years old;Subject who has signed a written informed consent;Subject with a Fitzpatrick phototype of I, II, III or IVSubject with a grade of photoaging of 2 or 3 on a scale of GlogauSubject having a wrinkle score according to Lemperle scale of 2, 3 or 4 at the level of periorbital linesSubject having at least:a Grade 1, 2, 3 or 4 on Bazin Neck Wrinkle Scale (at least N=30 subject for the control group)or a Grade 2, 3 or 4 on Landau Décolleté Wrinkle Scale (at least N=30 subject for the control group)Subject registered in social security system or other health insurance regimenSubject accepting not to expose Him/herself to the sun or ultraviolet (UV) during the entire duration of the study.Female subject accepting to take a pregnancy test.Exclusion Criteria:Subject involved in any other clinical study evaluating drugs or medical devices or subjects in exclusion periods of another clinical study.Subject deprived of freedom by an administrative or legal decisionUnable to follow protocol requirements.Subject who has received indemnification of 4500 € during the 12 previous months for his/her participation in clinical trials (including participation in this study).Subject having benefited from injection/facial implantation of any non-absorbable filling agent at any time of his/her life.Subject having already had laser sessions for skin rejuvenation or a laser facelift in the previous year or a facelift by surgery in the 2 years prior to the study.Subject with a history of fillers injections (hyaluronic acid type) in the last year or botulinum toxin in the last 6 months or the injectable implants (semi-permanent fillers) in the last two years.Subject with a skin support device (wire mesh, gold wire, liquid silicone or other particulate material) at the study zones.Subject having done a moderate to deep peeling or non-invasive rejuvenation techniques such as radiofrequency, ultrasound and lasers in the last 6 months.Subject with a history of multiple severe allergies or anaphylactic shock.Subject with a known hypersensitivity to hyaluronic acid, or other components of the NCTF 135HA solution.Subject with known intolerance/hypersensitivity to any cosmetic topical products, hyaluronic acid and/or other components of Hydra-Filler ® FILORGA Moisturizing Cream.Subject with a known hypersensitivity to chlorhexidine.Subject with a known hypersensitivity to lidocaine or to local amide-type anestheticsProne to developing inflammatory skin conditions or hypertrophic scarring according to investigator judgement.Subject with a history of streptococcal diseases (angina recurrent, rheumatic fever).Subject under concomitant treatment (or not stopped for at least 3 months) by oral or injectable corticosteroid (inhaled corticosteroids are allowed as well as a topical corticotherapy not involving the study zones).Subject under concomitant treatment (or not stopped for at least 1 year) by immunosuppressive or chemotherapy treatments.Subject with a history of less than one year of radiation therapy at the head and neck.Subject with an associated antecedent or pathology of autoimmune or connective tissue disease.Subject presenting a skin pathology, an acute inflammatory reaction or a bacterial or viral infection on the study zones or within the 6 weeks after the end of such an episode.Subject having taken aspirin or anticoagulants, at regular doses, in the last 15 days preceding the act.Subject that has been exposed to sun or UV in the last 15 days.Subject with a dermatological condition or inflammation at the treatment zone or near to this area (according to the investigator's judgment).Pregnant or lactating woman (Before every injection, a urinary pregnancy test will be performed).Subject having epilepsy uncontrolled by treatment.Subject presenting a general pathology, skin pathology, dermatosis, systemic, chronic or acute disease and/or topical or general treatment that in the opinion of the investigator may interfere with the treatment or compromise the participation of the subject in the study.