Open, Non-comparative Study to Evaluate the Effectiveness and Safety of the Medical Device KOS® L… (NCT06828224) | Clinical Trial Compass
CompletedNot Applicable
Open, Non-comparative Study to Evaluate the Effectiveness and Safety of the Medical Device KOS® L in Correcting Moderate or Severe Nasolabial Folds
Romania34 participantsStarted 2025-06-16
Plain-language 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.
Who can participate
Age range22 Years – 65 Years
SexALL
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Exclusion criteria
✕. 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
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What they're measuring
1
Proportion of subjects with at least 1-point improvement from baseline on the WSRS