Completed

KOS® M Device for Lip Augmentation

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What is being tested

KOS® M

Device
Who is being recruted

From 22 to 65 Years
+26 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: June 2025
See protocol details

Summary

Principal SponsorQuantum Beauty Kozmetik
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 17, 2025

Actual date on which the first participant was enrolled.

This study focuses on evaluating the effectiveness and safety of a medical device called KOS® M, which is used for lip augmentation. Lip augmentation is a popular cosmetic procedure aimed at enhancing the volume and shape of the lips. As people age, the midface region can lose volume, leading to a flat or sunken appearance. KOS® M is designed to help improve this by regulating water balance and supporting skin structures. By participating in this study, valuable information can be gathered to ensure that this device meets safety and performance standards, which could lead to improved options for individuals seeking facial rejuvenation. Participants in this study will receive the KOS® M treatment, which is applied directly to the skin. The study will closely monitor the effects of the device on lip augmentation, looking at how well it performs and any changes in the condition of the skin. While the study does not specify any potential risks or benefits, its aim is to collect data that demonstrate the device's safety and effectiveness. This information is crucial for ensuring that KOS® M can be used safely and effectively in cosmetic procedures.

Official TitleOpen, Non-comparative Study to Evaluate the Effectiveness and Safety of the Medical Device KOS® M in Lip Augmentation
NCT06858007
Principal SponsorQuantum Beauty Kozmetik
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

34 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 22 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

6 inclusion criteria required to participate
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
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20 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

An open, non-comparative, interventional single-armed clinical trial.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Clinica Beyond Dental

Timișoara, RomaniaOpen Clinica Beyond Dental in Google Maps
CompletedOne Study Center
KOS® M Device for Lip Augmentation | PatLynk