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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
34
Delivery of medical device as injection
Clinica Beyond Dental
Timișoara, Timiș County, Romania
Proportion of subjects with at least 1-point improvement from baseline on the AIHS
Proportion of subjects with at least 1-point improvement from baseline on the AIHS (Allergan Infraorbital Hollows Scale) at month 3 after the last treatment (response rate). Allergan Infraorbital Hollows Scale - from 0 (No visible hollowing or volume loss medially or laterally) to 4 (Defined hollowing extends from medial to lateral canthus, severe volume loss creates a marked step along the lid-cheek junction)
Time frame: 3 month
Change in the AIHS from baseline
Change in the AIHS from baseline at 1, 3, 6 and 12 months after the last treatment. Allergan Infraorbital Hollows Scale (AIHS) - from 0 (No visible hollowing or volume loss medially or laterally) to 4 (Defined hollowing extends from medial to lateral canthus, severe volume loss creates a marked step along the lid-cheek junction)
Time frame: 1, 3, 6 and 12 months
Proportion of participants with at least 1-point improvement from baseline on the AIHS
Proportion of participants with at least 1-point improvement from baseline on the AIHS at 1, 6 and 12 months after the last treatment (response rates) Allergan Infraorbital Hollows Scale (AIHS) - from 0 (No visible hollowing or volume loss medially or laterally) to 4 (Defined hollowing extends from medial to lateral canthus, severe volume loss creates a marked step along the lid-cheek junction)
Time frame: 1, 6 and 12 months
Change from baseline in FACE-Q Satisfaction with Eyes
Change from baseline in FACE-Q Satisfaction with Eyes scores at 1, 3, 6 and 12 months after the last treatment. FACE-Q Satisfaction with Eyes scale: from 1 (very dissatisfied) to 4 (very satisfied)
Time frame: 1, 3, 6 and 12 months
Secondary outcomes
Proportion of participants having a positive aesthetic evolution on the 5-point Global Aesthetic Improvement Scale (GAIS) evaluated by the physician and subject at 1, 3, 6 and 12 months after the last treatment
Time frame: 1, 3, 6 and 12 months
Short- and long-term adverse effects
Short- and long-term adverse effects within 2 weeks of the initial or touch-up treatment and during 6, 12 months after the last treatment of the study course, respectively
Time frame: 2 weeks, 6, 12 months
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