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

NCT06828198 | Completed

• 1 other identifier: TGMQUA/0424/MD
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Facial Volume

Keywords

restoration and/or augmentation of facial volume

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Facial Volume Loss Scale (FVLS)

  1, 3 and 12 months

• Proportion of participants with at least 1-point improvement on the Facial Volume Loss Scale (FVLS)

  1, 3, 6 and 12 months

• Proportion of participants having a positive aesthetic evolution on the 5-point GAIS

  1, 3, 6 and 12 months

• Change from baseline in FACE-Q satisfaction

  1, 3, 6 and 12 months

• Short- and long-term adverse effects

  6 and 12 months

Study Arms (1)

KOS® XL

OTHER

An open, non-comparative, interventional single-armed clinical trial.

Device: KOS® XL

Interventions

KOS® XL DEVICE

Delivery of medical device as injection

KOS® XL

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Subject with a scar, moles or anything on the face which might interfere with the evaluation
• 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, …)
• History of or active autoimmune disease/immune deficiency
• Suffering from inflammatory and/or infectious cutaneous disorders in or near the studied zones (herpes, acne, mycosis, papilloma…)
• Prone to hypertrophic scars
• History of allergy to hyaluronic acid or any of the product's components
• History of allergy to lidocaine or local anaesthesia of amide compounds
• Known case of porphyria
• Pregnancy or lactation
• Taking medications and/or substances known to increase coagulation time (e.g., aspirin, ibuprofen, or herbal supplements) 10 days prior to treatment
• 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
• Untreated epilepsy
• Hypersensitivity to gram positive bacterial proteins as hyaluronic acid is produced by Streptococcus type bacteria.

Sponsors & Collaborators

• Quantum Beauty Kozmetik: lead
• Opera CRO, a TIGERMED Group Company: collaborator

Study Sites (1)

Clinica Beyond Dental

Timișoara, Romania

Location

Related Publications (2)

• 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.

  PMID: 25763894 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.

  PMID: 37700793 BACKGROUND

Study Officials

• Behnam D Bayatani

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 14, 2025
• Study Start: June 16, 2025
• Primary Completion: July 17, 2025
• Study Completion: July 17, 2025
• Last Updated: August 21, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)