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. KOS® XL 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® XL when used as intended.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Delivery of medical device as injection
Clinica Beyond Dental
Timișoara, Romania
Mean change in facial volume
Mean change in facial volume from baseline on the Facial Volume Loss Scale (FVLS) at month 6 after the last treatment FVLS scale from 1 to 5; where 5 is representing severe indentation of one or more facial regions
Time frame: 6 months
Facial Volume Loss Scale (FVLS)
Change in the FVLS from baseline at 1, 3 and 12 months after the last treatment. FVLS scale from 1 to 5; where 5 is representing severe indentation of one or more facial regions
Time frame: 1, 3 and 12 months
Proportion of participants with at least 1-point improvement on the Facial Volume Loss Scale (FVLS)
Proportion of participants with at least 1-point improvement from baseline on the FVLS at 1, 3, 6 and 12 months after the last treatment (response rates). FVLS scale from 1 to 5; where 5 is representing severe indentation of one or more facial regions
Time frame: 1, 3, 6 and 12 months
Proportion of participants having a positive aesthetic evolution on the 5-point GAIS
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 GAIS scale: from 1 (very much improved) to 5 (worse)
Time frame: 1, 3, 6 and 12 months
Change from baseline in FACE-Q satisfaction
Change from baseline in FACE-Q satisfaction with cheekbones and FACE-Q satisfaction with chin at 1, 3, 6 and 12 months after the last treatment FACE-Q satisfaction with cheekbones scale: from 1 (very dissatisfied) to 4 (very satisfied) FACE-Q satisfaction with chin scale: from 1 (very dissatisfied) to 4 (very satisfied)
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: 6 and 12 months
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