Clareo Health | Open, Non-comparative Study to Evaluate the Effectiveness and Safety of the Medical Device KOS® L in Correcting Moderate or Severe Nasolabial Folds
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Quantum Beauty Kozmetik
Age
22–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
1. 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, …)
2. 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
3. Severe midface volume loss or severity of wrinkles or folds requiring other treatments
4. Previous tissue revitalization with neurotoxin, laser or light, mesotherapy, chemical peeling, or dermabrasion below the zygomatic arch within 6 months
5. Previous tissue augmenting therapy or, contouring, or fat injection in the facial area
6. Subject with a tattoo, a scar, moles or anything on the studied zones which might interfere with the evaluation
7. 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
8. History of allergy to lidocaine or local anaesthesia of amide compounds
9. Suffering from inflammatory and/or infectious cutaneous disorders in or near the studied zones (herpes, acne, mycosis, papilloma…)
10. Body mass index BMI\<18 or \>30 kg/m2
11. Smoker with \>10 pack-year history within the past year
12. 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)
13. History of or active autoimmune disease/immune deficiency
14. Prone to hypertrophic scars
15. History of allergy to hyaluronic acid or any of the product's components
16. Known case of porphyria
17. Pregnancy or lactation
18. Taking medications and/or substances known to increase coagulation time (e.g., aspirin, ibuprofen, or herbal supplements) 10 days prior to treatment
19. 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
20. Untreated epilepsy
21. Hypersensitivity to gram positive bacterial proteins as hyaluronic acid is produced by Streptococcus type bacteria.
