Nasolabial FoldNCT06828224
Open, Non-comparative Study to Evaluate the Effectiveness and Safety of the Medical Device KOS® L in Correcting Moderate or Severe Nasolabial Folds
A study testing KOS® L in people with Nasolabial Fold, run by Quantum Beauty Kozmetik at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Nasolabial Fold
- What is being tested?
- KOS® L
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteRomania
- Study dates
- 16 Jun 2025to 17 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 21Show fewer
- 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
- Known case of porphyria
- Pregnancy or lactation
- Taking medications and/or substances known to increase coagulation time (e.g., aspirin, ibuprofen, or herbal supplements) 10 days prior to treatment
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- KOS® L
- Keywords
- "Moderate" or "Severe" nasolabial folds (NLFs)
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KOS® LDevice
Delivery of medical device as injection
| Study group | Role | What they receive |
|---|---|---|
| KOS® L | Other | An open, non-comparative, interventional single-armed clinical trial. Receives: Device: KOS® L |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 month
Secondary outcomes (5)
Change in Wrinkle Severity Rating Scale from baseline
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)
Measured: 1, 3, 6 and 12 months
Proportion of participants with at least 1-point improvement from baseline on the WSRS
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)
Measured: 1, 3 and 12 months
Change from baseline in FACE-Q Satisfaction with Facial Appearance
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)
Measured: 1, 3, 6 and 12 months
Proportion of participants having a positive aesthetic evolution on the 5-point GAIS
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)
Measured: 1, 3, 6 and 12 months
Short- and long-term adverse effects
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.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start16 Jun 2025
- Primary completion17 Jul 2025
- Study completion17 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nasolabial FoldStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quantum Beauty Kozmetik
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Behnam D Bayatani, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828224
- Sponsor's protocol ID
- TGMQUA/0324/MD
- Status last verified
- Jun 2025
- First submitted
- 5 Feb 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25763894Monheit 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.
PubMed 29701621
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Non-comparative Study to Evaluate the Effectiveness and Safety of the Medical Device KOS® L in Correcting Moderate or Severe Nasolabial Folds
- ClinicalTrials.gov ID
- NCT06828224
- Acronym / sponsor ID
- TGMQUA/0324/MD
- Conditions
- Nasolabial Fold
- Keywords
- "Moderate" or "Severe" nasolabial folds (NLFs)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Quantum Beauty KozmetikIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 17 Jul 2025 (actual)
- Study completion
- 17 Jul 2025 (actual)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KOS® L | Other | Device: KOS® LAn open, non-comparative, interventional single-armed clinical trial. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KOS® LDelivery of medical device as injection | Device | KOS® L |
Primary outcome
Proportion of subjects with at least 1-point improvement from baseline on the WSRS
Time frame: 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)
5 secondary outcomes
Change in Wrinkle Severity Rating Scale from baseline
Time frame: 1, 3, 6 and 12 months
Proportion of participants with at least 1-point improvement from baseline on the WSRS
Time frame: 1, 3 and 12 months
Change from baseline in FACE-Q Satisfaction with Facial Appearance
Time frame: 1, 3, 6 and 12 months
Proportion of participants having a positive aesthetic evolution on the 5-point GAIS
Time frame: 1, 3, 6 and 12 months
Short- and long-term adverse effects
Time frame: 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Background: PubMed 25763894Attenello 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.
- Background: PubMed 29701621Monheit 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.
- Champely, S. (2020). pwr: Basic Functions for Power Analysis. R package version 1.3-0.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Behnam D Bayatani study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KOS® L in people with Nasolabial Fold, run by Quantum Beauty Kozmetik at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with at least 1-point improvement from baseline on the WSRS (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06828224, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.