NCT06858007

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Quantum Beauty Kozmetik · Industry
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	KOS® M	Delivery of medical device as injection

Timeline

• Start date: 2025-06-17
• Primary completion: 2025-07-16
• Completion: 2025-07-16
• First posted: 2025-03-05
• Last updated: 2025-08-21

Locations

1 site across 1 country: Romania