NCT06828237

Open, Non-comparative Study to Evaluate the Effectiveness and Safety of the Medical Device KOS® S in the Correction of Moderate or Severe Infraorbital Hollowing

• 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 process of facial aging is a result of intricate alterations occurring at both the microscopic and macroscopic levels, leading to changes in facial volume. The observed alterations can be attributed to the process of bone structure resorption, the influence of gravity, redistribution of subcutaneous fat, and injury to the skin. Dermal fillers are utilized for the purpose of enhancing facial features in accordance with the aesthetic ideals of beauty. These ideals prescribe specific curves, contours, dimensions, and ratios that must be achieved in order to create a face that is generally considered appealing. Additionally, dermal fillers are employed to replenish volumetric dimensions and restore a more youthful appearance to the aging face (Wongprasert et al. 2022). Over a period of time, the convex shape of the midface region has the potential to undergo a flattening or concave transformation. The contour alterations observed can be attributed to the descent of the malar soft tissue complex from the zygoma and orbital rims in an inferomedial direction, as well as the atrophy of the malar fat pad. The malar groove, also known as the zygomatic hollow, is a linear indentation that traverses the zygoma in a diagonal manner, running parallel to the nasolabial fold. Dermal fillers have the potential to reinstate midface volume effectively and augment malar features. The malar augmentation technique involves using dermal filler materials that provide enhanced structural support, making it an operation that is classified as advanced within the field of dermal fillers (Small, Hoang 2012). KOS® S 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® S when used as intended. The primary objective of the study is to evaluate the effectiveness of KOS® S in correcting "Moderate" or "Severe" infraorbital hollowing by assessing the response rate using the Allergan Infraorbital Hollows Scale (AIHS) from the baseline (Response is defined as at least 1-point improvement on the AIHS at month 3 after last treatment).

Conditions

• Infraorbital Hollowing

Interventions

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

Timeline

• Start date: 2025-06-13
• Primary completion: 2025-07-12
• Completion: 2025-07-12
• First posted: 2025-02-14
• Last updated: 2025-08-21

Locations

1 site across 1 country: Romania