Open, Non-comparative Study to Evaluate the Effectiveness and Safety of the Medical Device KOS® XL for the Restoration and/or Augmentation of Facial Volume

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 Overview

• Status: Completed
• Conditions: Facial Volume
• Intervention / Treatment: Device: KOS® XL

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Romania
  • Timişoara, Romania
    • Clinica Beyond Dental

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Females and males ≥ 22years of age
• Signed informed consent by the subject
• Subject with grade from 3 to 5 on the FVLS.
• Ability to follow study instructions and likely to complete all required visits
• Reliable methods of contraception which result in a low failure rate (i.e. less than 1 % per year) for women of childbearing potential, e.g. implants, injectables, combined oral contraceptives, some intrauterine -devices, sexual abstinence or vasectomized partner) for the entire study duration.

Exclusion Criteria:

1. Using any new over-the-counter or prescription oral or topical, anti-wrinkle products within 30 days before enrolment or planning to begin using such products during the study (Subjects who have been on a regimen of such products for at least 30 days are eligible for the study if they intend to continue their regimen throughout the study).
2. Subject with a scar, moles or anything on the face which might interfere with the evaluation
3. Subject having received treatment with a laser, a dermabrasion, a surgery, a deep chemical peeling or other ablative procedure on the face within the past 12 months prior to inclusion
4. Subject having received injection with a resorbable filling product in the face area within the past 18 months prior to inclusion
5. Subject having received at any time injection with a slowly resorbable filling product (polylactic acid, calcium hydroxyapatite, combinations of hyaluronic acid (HA) and hypromellose, HA and dextran microbeads or HA and TriCalcium Phosphate (TCP), …) or with a non-resorbable filling product (polyacrylamide, silicone, combination of methacrylic polymers and collagen, polymer particles, …)
6. History of or active autoimmune disease/immune deficiency
7. Suffering from inflammatory and/or infectious cutaneous disorders in or near the studied zones (herpes, acne, mycosis, papilloma…)
8. Prone to hypertrophic scars
9. History of allergy to hyaluronic acid or any of the product's components
10. History of allergy to lidocaine or local anaesthesia of amide compounds
11. Known case of porphyria
12. Pregnancy or lactation
13. Taking medications and/or substances known to increase coagulation time (e.g., aspirin, ibuprofen, or herbal supplements) 10 days prior to treatment
14. Have a condition or be in a situation that, in the physician's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
15. Untreated epilepsy
16. Hypersensitivity to gram positive bacterial proteins as hyaluronic acid is produced by Streptococcus type bacteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: KOS® XL; An open, non-comparative, interventional single-armed clinical trial.	Device: KOS® XL; Delivery of medical device as injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)	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

Collaborators and Investigators

• Sponsor: Quantum Beauty Kozmetik
• Collaborators: Opera CRO, a TIGERMED Group Company
• Investigators: Study Chair: Behnam D Bayatani

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2025
• Primary Completion (Actual): July 17, 2025
• Study Completion (Actual): July 17, 2025

Study Registration Dates

• First Submitted: February 5, 2025
• First Submitted That Met QC Criteria: February 13, 2025
• First Posted (Actual): February 14, 2025

Study Record Updates

• Last Update Posted (Actual): August 21, 2025
• Last Update Submitted That Met QC Criteria: August 20, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: restoration and/or augmentation of facial volume
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Facies
• Other Study ID Numbers: TGMQUA/0424/MD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No