Clinical trial NCT06828198: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Facial Volume
Keywords: restoration and/or augmentation of facial volume
Lead sponsor: Quantum Beauty Kozmetik
Sponsor class: INDUSTRY
Collaborators: name: Opera CRO, a TIGERMED Group Company
First posted: 2025-02-14
Enrollment: 34
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean change in facial volume
timeFrame: 6 months
Secondary outcomes:
measure: Facial Volume Loss Scale (FVLS)
timeFrame: 1, 3 and 12 months
measure: Proportion of participants with at least 1-point improvement on the Facial Volume Loss Scale (FVLS)
timeFrame: 1, 3, 6 and 12 months
measure: Proportion of participants having a positive aesthetic evolution on the 5-point GAIS
timeFrame: 1, 3, 6 and 12 months
measure: Change from baseline in FACE-Q satisfaction
timeFrame: 1, 3, 6 and 12 months
measure: Short- and long-term adverse effects
timeFrame: 6 and 12 months
Other outcomes:
Locations:
Study officials:
name: Behnam D Bayatani
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.