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Lip AugmentationNCT06858007

Open, Non-comparative Study to Evaluate the Effectiveness and Safety of the Medical Device KOS® M in Lip Augmentation

A study testing KOS® M in people with Lip Augmentation, run by Quantum Beauty Kozmetik at 1 site in Romania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
Lip Augmentation
What is being tested?
KOS® M
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteRomania
Study dates
17 Jun 2025to 16 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
  • Females and males ≥ 22 years of age
  • Scoring 0 (minimal), 1 (mild) and 2 (moderate) on the 5-point Allergan LFS
  • Have established a realistic treatment goal that the physician agrees is achievable, i.e., have realistic expectations of aesthetic results
  • 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

  • Has Inflamed or infected skin in or near the studied zones
  • History of or active autoimmune disease/immune deficiency
  • History of any disease resulting in changes of facial contour or edema of the face during the study period
  • Significant abnormalities of the lips
  • Has lip tattoos, piercings, facial hair, or scars that would interfere with visualization of the lips and perioral area for the effectiveness assessments
  • Has dentures or any device covering all or part of the upper palate, and/or severe malocclusion or dentofacial or maxillofacial deformities as judged by the Treating Investigator
Show all 20Show fewer
  • Has undergone oral surgery (e.g., tooth extraction, orthodontia, or implantation) within 6 weeks before enrollment or is planning to undergo any of these procedures during the study
  • Has ever undergone facial plastic surgery or received permanent facial implants (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene) anywhere in the face or neck, or is planning to be implanted with any of these products during the study
  • Has undergone semipermanent dermal filler treatment (e.g., calcium hydroxylapatite, poly-L- lactic acid) in the lower face (below the orbital rim) within 24 months before enrollment or is planning to undergo such treatment during the study
  • Has undergone temporary dermal filler treatment (e.g., hyaluronic acid or collagen) in the lower face (below the orbital rim) within 12 months before enrollment or is planning to undergo such treatment during the study
  • Taking medications and/or substances known to increase coagulation time (e.g., aspirin, ibuprofen, or herbal supplements) 10 days prior to treatment
  • Has undergone mesotherapy or cosmetic resurfacing (laser, photo-modulation, intense pulsed light, radiofrequency, dermabrasion, chemical peel, or other ablative or non-ablative procedures) anywhere in the face or neck, or Botulinum toxin injections in the lower face (below the orbital rim) within 6 months before enrollment or is planning to undergo any of these procedures during the study
  • Prone to hypertrophic scars
  • History of allergy to hyaluronic acid or any of the product's components
  • History of allergy to lidocaine or local anaesthesia of amide compounds
  • Known case of porphyria
  • Pregnancy or lactation
  • 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.

Romania1 site

  • Clinica Beyond Dental

    Timișoara, Timiș County

Other trials in Romania

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.

Over a period of time, the convex shape of the midface region has the potential to undergo a flattening or concave transformation.

Read more

KOS® M 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® M when used as intended.

Being tested
KOS® M
Keywords
Lip augmentation improvement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KOS® MDevice

    Delivery of medical device as injection

Study groups in NCT06858007
Study groupRoleWhat they receive
KOS® MOtherAn open, non-comparative, interventional single-armed clinical trial.
Receives: Device: KOS® M

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the effectiveness of KOS® M in lip augmentation

    The primary objective of the study is to evaluate the effectiveness of KOS® M in lip augmentation by assessing changes in the Allergan Lip Fullness Scale (ALFS). Response is defined as a ≥1 point improvement in ALFS at 3 months after last treatment.

    Allergan Lip Fullness Scale - from Minimal (Flat or nearly flat contour; minimal red lip shows) to Very Marked (Very significant red lip shows, lower lip pout, and lip pout)

    Measured: 3 months

Secondary outcomes (7)

  1. Effectiveness on KOS® M in lip augmentation

    Effectiveness on KOS® M in lip augmentation through the assessment of the change in ALFS Allergan Lip Fullness Scale - from Minimal (Flat or nearly flat contour; minimal red lip shows) to Very Marked (Very significant red lip shows, lower lip pout, and lip pout)

    Measured: 3 months

  2. Effectiveness on KOS® M in lip augmentation

    Effectiveness on KOS® M in lip augmentation through the assessment of the change in FACE-Q Satisfaction with lips FACE-Q Satisfaction with lips - from 1 (Very Dissatisfied) to 4 (Very satisfied)

    Measured: 3 months

  3. Effectiveness on KOS® M in lip augmentation

    Effectiveness on KOS® M in lip augmentation through the assessment of the change in GAIS GAIS-The global aesthetic improvement scale - from 1 (very much improved) to 5 (worse)

    Measured: 3 months

  4. Change in the ALFS (Allergan Lip Fullness Scale) Grade from baseline

    Change in the ALFS (Allergan Lip Fullness Scale) Grade from baseline at 1, 3, 6 and 12 months after the last treatment.

    Allergan Lip Fullness Scale - grade from Minimal (Flat or nearly flat contour; minimal red lip shows) to Very Marked (Very significant red lip shows, lower lip pout, and lip pout)

    Measured: 1, 3, 6 and 12 months

  5. Proportion of participants with at least 1-point improvement from baseline on the ALFS

    Proportion of participants with at least 1-point improvement from baseline on the ALFS at 1,6 and 12 months after the last treatment (response rates) Allergan Lip Fullness Scale - grade from Minimal (Flat or nearly flat contour; minimal red lip shows) to Very Marked (Very significant red lip shows, lower lip pout, and lip pout)

    Measured: 1,6 and 12 months

  6. Change from baseline in FACE-Q Satisfaction with Lips scores

    Change from baseline in FACE-Q Satisfaction with Lips scores at 1, 3, 6 and 12 months after the last treatment.

    FACE-Q Satisfaction with Lips scores - from 1 (Very Dissatisfied) to 4 (Very satisfied)

    Measured: 1, 3, 6 and 12 months

  7. Proportion of participants having a positive aesthetic evolution on the 5-point Global Aesthetic Improvement Scale (GAIS)

    Proportion of participants having a positive aesthetic evolution on the 5-point Global Aesthetic Improvement Scale (GAIS) evaluated by the physician and subject on the lips at 1, 3, 6 and 12 months after the last treatment GAIS (The Global Aesthetic Improvement Scale) - from 1 (Very much improved) to 5 (worse)

    Measured: 1, 3, 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.

  1. First posted5 Mar 2025
  2. Study start17 Jun 2025
  3. Primary completion16 Jul 2025
  4. Study completion16 Jul 2025

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06858007
Sponsor's protocol ID
TGMQUA/0224/MD
Status last verified
Aug 2025
First submitted
4 Feb 2025
Last updated
21 Aug 2025
Results posted
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 25763894

  • Werschler WP, Fagien S, Thomas J, Paradkar-Mitragotri D, Rotunda A, Beddingfield FC 3rd. Development and validation of a photographic scale for assessment of lip fullness. Aesthet Surg J. 2015 Mar;35(3):294-307. doi: 10.1093/asj/sju025.

    PubMed 25805282

  • Dayan S, Bruce S, Kilmer S, Dover JS, Downie JB, Taylor SC, Skorupa A, Murphy DK. Safety and Effectiveness of the Hyaluronic Acid Filler, HYC-24L, for Lip and Perioral Augmentation. Dermatol Surg. 2015 Dec;41 Suppl 1:S293-301. doi: 10.1097/DSS.0000000000000540.

    PubMed 26618456

Questions about this trial

What is this clinical trial studying?

A study testing KOS® M in people with Lip Augmentation, 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 6 inclusion and 20 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?

Evaluate the effectiveness of KOS® M in lip augmentation (time frame: 3 months). 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 NCT06858007, which also lists 3 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.

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