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

NCT06858007 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-08-21

No results posted yet for this study

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.

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.

Conditions

  • Lip Augmentation

Interventions

DEVICE

KOS® M

Delivery of medical device as injection

Sponsors & Collaborators

  • Opera CRO, a TIGERMED Group Company

    collaborator OTHER

  • Quantum Beauty Kozmetik

    lead INDUSTRY

Principal Investigators

  • Behnam D Bayatani

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-17
Primary Completion
2025-07-16
Completion
2025-07-16

Countries

  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06858007 on ClinicalTrials.gov