Nasolabial Fold
Conditions
Keywords
Moderate or Severe nasolabial folds (NLFs)
Brief summary
The utilization of minimally invasive techniques has brought about a transformative shift in the approach to face rejuvenation, potentially representing one of the most notable advancements in facial plastic surgery in recent times. Originally employed to address the presence of fine lines and wrinkles, the application of fillers has now evolved to encompass the remediation of volume depletion and the enhancement of the aging visage. KOS® L in the dermis regulates water balance, osmotic pressure and ion flow and functions as a sieve, excluding certain molecules, enhancing the extracellular domain of cell surfaces and stabilizes skin structures by electrostatic interactions. The Research Question of the present study is the following: to collect sufficient clinical data to demonstrate compliance with the General Safety and Performance Requirements of KOS® L when used as intended.
Interventions
DEVICEKOS® L
Delivery of medical device as injection
Sponsors
Quantum Beauty Kozmetik
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with at least 1-point improvement from baseline on the WSRS | 6 month | Proportion of subjects with at least 1-point improvement from baseline on the WSRS (Wrinkle Severity Rating Scale) at month 6 after the last treatment (response rate). Wrinkle Severity Rating Scale - from 1 (No visible nasolabial folds) to 5 (Extremely long and deep nasolabial folds) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Wrinkle Severity Rating Scale from baseline | 1, 3, 6 and 12 months | Change in WSRS (Wrinkle Severity Rating Scale) from baseline at 1, 3, 6 and 12 months after the last treatment. Wrinkle Severity Rating Scale - from 1 (No visible nasolabial folds) to 5 (Extremely long and deep nasolabial folds) |
| Proportion of participants with at least 1-point improvement from baseline on the WSRS | 1, 3 and 12 months | Proportion of participants with at least 1-point improvement from baseline on the WSRS (Wrinkle Severity Rating Scale) at 1, 3 and 12 months after the last treatment (response rates) Wrinkle Severity Rating Scale - from 1 (No visible nasolabial folds) to 5 (Extremely long and deep nasolabial folds) |
| Change from baseline in FACE-Q Satisfaction with Facial Appearance | 1, 3, 6 and 12 months | Change from baseline in FACE-Q Satisfaction with Facial Appearance at 1, 3, 6 and 12 months after the last treatment FACE-Q Satisfaction with Facial Appearance scale - from 1 (Very Dissatisfied) to 4 (Very satisfied) |
| Proportion of participants having a positive aesthetic evolution on the 5-point GAIS | 1, 3, 6 and 12 months | Proportion of participants having a positive aesthetic evolution on the 5-point Global Aesthetic Improvement Scale (GAIS) evaluated by the physician and subject at 1, 3, 6 and 12 months after the last treatment. 5-point Global Aesthetic Improvement Scale - from 1 (very much improved) to 5 (worse) |
| Short- and long-term adverse effects | 6 and 12 months | Short- and long-term adverse effects within 2 weeks of the initial or touch-up treatment and during 6, 12 months after the last treatment of the study course, respectively. |
Countries
Romania
Outcome results
None listed