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NCT06858007
Open, Non-comparative Study to Evaluate the Effectiveness and Safety of the Medical Device KOS® M in Lip Augmentation
NA trial testing KOS® M in Lip Augmentation in 34 participants. Completed in 16 July 2025.
16 July 2025
Quick facts
| Lead sponsor | Quantum Beauty Kozmetik |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 34 |
| Start date | 17 June 2025 |
| Primary completion | 16 July 2025 |
| Estimated completion | 16 July 2025 |
| Sites | 1 location across Romania |
Drugs / interventions tested
- KOS® M
Conditions studied
- Lip Augmentation — all drugs for Lip Augmentation →
Sponsor
Quantum Beauty Kozmetik
Who can join
Adults 22 to 65, any sex, with Lip Augmentation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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. 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06858007
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Quantum Beauty Kozmetik trials
Trials by the same sponsor.
- NCT06828198 — Open, Non-comparative Study to Evaluate the Effectiveness and Safety of the Medical Device KOS® XL for the Restoration a · NA · completed
- NCT06828224 — Open, Non-comparative Study to Evaluate the Effectiveness and Safety of the Medical Device KOS® L in Correcting Moderate · NA · completed
- NCT06828237 — Open, Non-comparative Study to Evaluate the Effectiveness and Safety of the Medical Device KOS® S in the Correction of M · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06858007 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Quantum Beauty Kozmetik
- Last refreshed: 21 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06858007.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing