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| Name | Class |
|---|---|
| Opera CRO, a TIGERMED Group Company | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KOS® XL | Other | An open, non-comparative, interventional single-armed clinical trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KOS® XL | Device | Delivery of medical device as injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1, 3 and 12 months |
| Proportion of participants with at least 1-point improvement on the Facial Volume Loss Scale (FVLS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Behnam D Bayatani | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Beyond Dental | Timișoara | Romania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25763894 | Background | Attenello NH, Maas CS. Injectable fillers: review of material and properties. Facial Plast Surg. 2015 Feb;31(1):29-34. doi: 10.1055/s-0035-1544924. Epub 2015 Mar 12. | |
| 37700793 | Background | Mojallal A. Efficacy and Safety of Stylage XL Lidocaine for the Restoration and/or Augmentation of Facial Volume: The Beauty Volume Study. Aesthet Surg J Open Forum. 2023 Jun 26;5:ojad056. doi: 10.1093/asjof/ojad056. eCollection 2023. |
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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 |
| 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) | 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) | 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. | 6 and 12 months |