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

NCT06828224 | Completed

• 1 other identifier: TGMQUA/0324/MD
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasolabial Fold

Keywords

"Moderate" or "Severe" nasolabial folds (NLFs)

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with at least 1-point improvement from baseline on the WSRS

  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)

  6 month

Secondary Outcomes (5)

• Change in Wrinkle Severity Rating Scale from baseline

  1, 3, 6 and 12 months

• Proportion of participants with at least 1-point improvement from baseline on the WSRS

  1, 3 and 12 months

• Change from baseline in FACE-Q Satisfaction with Facial Appearance

  1, 3, 6 and 12 months

• Proportion of participants having a positive aesthetic evolution on the 5-point GAIS

  1, 3, 6 and 12 months

• Short- and long-term adverse effects

  6 and 12 months

Study Arms (1)

KOS® L

OTHER

An open, non-comparative, interventional single-armed clinical trial.

Device: KOS® L

Interventions

KOS® L DEVICE

Delivery of medical device as injection

KOS® L

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 qualify if:

• 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, …)
• 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
• Severe midface volume loss or severity of wrinkles or folds requiring other treatments
• 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 with a tattoo, a scar, moles or anything on the studied zones which might interfere with the evaluation
• 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
• 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…)
• Body mass index BMI\<18 or \>30 kg/m2
• Smoker with \>10 pack-year history within the past year
• 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)
• History of or active autoimmune disease/immune deficiency
• Prone to hypertrophic scars
• History of allergy to hyaluronic acid or any of the product's components

Sponsors & Collaborators

• Quantum Beauty Kozmetik: lead

Study Sites (1)

Clinica Beyond Dental

Timișoara, Timiș County, Romania

Location

Related Publications (2)

• Attenello NH, Maas CS. Injectable fillers: review of material and properties. Facial Plast Surg. 2015 Feb;31(1):29-34. doi: 10.1055/s-0035-1544924. Epub 2015 Mar 12.

  PMID: 25763894 BACKGROUND

• Monheit G, Beer K, Hardas B, Grimes PE, Weichman BM, Lin V, Murphy DK. Safety and Effectiveness of the Hyaluronic Acid Dermal Filler VYC-17.5L for Nasolabial Folds: Results of a Randomized, Controlled Study. Dermatol Surg. 2018 May;44(5):670-678. doi: 10.1097/DSS.0000000000001529.

  PMID: 29701621 BACKGROUND

Related Links

• Champely, S. (2020). pwr: Basic Functions for Power Analysis. R package version 1.3-0.

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Behnam D Bayatani

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 14, 2025
• Study Start: June 16, 2025
• Primary Completion: July 17, 2025
• Study Completion: July 17, 2025
• Last Updated: August 21, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)