Open, Non-comparative Study to Evaluate the Effectiveness and Safety of the Medical Device KOS® L in Correcting Moderate or Severe Nasolabial Folds

Korábbi kezelés

• Subject who received oral surgery (e.g. tooth extraction, orthodontia or implantation) within 6 weeks prior to screening visit or who plans to undergo any of these procedures during the study
• Previous tissue revitalization with neurotoxin, laser or light, mesotherapy, chemical peeling, or dermabrasion below the zygomatic arch within 6 months
• Previous tissue augmenting therapy or, contouring, or fat injection in the facial area
• Subject having received injection with a resorbable filling product (eg, hyaluronic acid, collagen) below the inferior orbital rim within the past 12 months prior to screening visit
• Using any new over-the-counter or prescription oral or topical, anti-wrinkle products within 30 days before enrolment or is planning to begin using such products during the study. (Subjects who have been on a regimen of such products for at least 30 days are eligible for the study if they intend to continue their regimen throughout the study)
• Taking medications and/or substances known to increase coagulation time (e.g., aspirin, ibuprofen, or herbal supplements) 10 days prior to treatment

Más betegség

• History of allergy to lidocaine or local anaesthesia of amide compounds
• Suffering from inflammatory and/or infectious cutaneous disorders in or near the studied zones (herpes, acne, mycosis, papilloma…)
• History of or active autoimmune disease/immune deficiency
• History of allergy to hyaluronic acid or any of the product's components
• Have a condition or be in a situation that, in the physician's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
• Untreated epilepsy
• Hypersensitivity to gram positive bacterial proteins as hyaluronic acid is produced by Streptococcus type bacteria.

Laborértékek

• 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 permanent filling product (polyacrylamide, silicone, combination of methacrylic polymers and collagen, polymer particles, …)

Egyéb

• Severe midface volume loss or severity of wrinkles or folds requiring other treatments
• Subject with a tattoo, a scar, moles or anything on the studied zones which might interfere with the evaluation
• Body mass index BMI<18 or >30 kg/m2
• Smoker with >10 pack-year history within the past year
• Prone to hypertrophic scars
• Known case of porphyria
• Pregnancy or lactation

• Signed informed consent by the subject
• Men and women with ≥ 22 years of age
• Two fully visible bilateral nasolabial folds, each with a Wrinkle Severity Rating Scale Score of moderate (3) or severe (4) based on the 5-point WSRS
• Ability to follow study instructions and likely to complete all required visits
• Reliable methods of contraception which result in a low failure rate (i.e. less than 1 % per year) for women of childbearing potential, e.g. implants, injectables, combined oral contraceptives, some intrauterine-devices, sexual abstinence or vasectomized partner) for the entire study duration.