Infraorbital HollowingNCT06828237
Open, Non-comparative Study to Evaluate the Effectiveness and Safety of the Medical Device KOS® S in the Correction of Moderate or Severe Infraorbital Hollowing
A study testing KOS® S in people with Infraorbital Hollowing, run by Quantum Beauty Kozmetik at 1 site in Romania.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Infraorbital Hollowing
- What is being tested?
- KOS® S
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteRomania
- Study dates
- 13 Jun 2025to 12 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent by the subject
- Females and males ≥ 22 years of age
- Has "Moderate" or "Severe" infraorbital hollowing (grade 2 or 3 on the AIHS) on the 5-point AIHS for each eye as assessed by the Evaluating Investigator (i.e., both eyes must qualify but do not need to have the same score)
- 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.
Who cannot join
- Has hyperpigmentation in the infraorbital area (does not include dark circles under the eyes, not due to hyperpigmentation).
- Has ever received permanent facial implants (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene) anywhere in the face or neck, or is planning to be implanted with any of these products during the study
- Has ever undergone fat injections above the subnasale or is planning to undergo this procedure during the study
- Has tattoos, piercings, facial hair (i.e., beard, moustache), or scars that would interfere with visual assessment of the infraorbital hollows
- Has undergone volume augmentation with semi-permanent dermal fillers (e.g., calcium hydroxyapatite, poly-L-lactic acid) or temporary dermal fillers in the malar area, temples, or around the eyes within 12 months before enrolment or is planning to undergo such treatment during the study
- Using any new over-the-counter or prescription oral or topical, anti-wrinkle products within 30 days before enrolment or is 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)
Show all 19Show fewer
- Has congenital or acquired deformities of theface, lipodystrophy, or poor nutritional status
- Has active or recurrent inflammation or infection in either eye
- History of or active autoimmune disease/immune deficiency
- Taking medications and/or substances known to increase coagulation time (e.g., aspirin, ibuprofen, or herbal supplements) 10 days prior to treatment
- Simultaneousness with laser therapy or deep chemical peeling
- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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. These ideals prescribe specific curves, contours, dimensions, and ratios that must be achieved in order to create a face that is generally considered appealing. Additionally, dermal fillers are employed to replenish volumetric dimensions and restore a more youthful appearance to the aging face (Wongprasert et al. 2022).
Over a period of time, the convex shape of the midface region has the potential to undergo a flattening or concave transformation. The contour alterations observed can be attributed to the descent of the malar soft tissue complex from the zygoma and orbital rims in an inferomedial direction, as well as the atrophy of the malar fat pad. The malar groove, also known as the zygomatic hollow, is a linear indentation that traverses the zygoma in a diagonal manner, running parallel to the nasolabial fold.
Read more
Dermal fillers have the potential to reinstate midface volume effectively and augment malar features. The malar augmentation technique involves using dermal filler materials that provide enhanced structural support, making it an operation that is classified as advanced within the field of dermal fillers (Small, Hoang 2012).
KOS® S 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® S when used as intended.
The primary objective of the study is to evaluate the effectiveness of KOS® S in correcting "Moderate" or "Severe" infraorbital hollowing by assessing the response rate using the Allergan Infraorbital Hollows Scale (AIHS) from the baseline (Response is defined as at least 1-point improvement on the AIHS at month 3 after last treatment).
- Conditions
- Infraorbital Hollowing
- Being tested
- KOS® S
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KOS® SDevice
Delivery of medical device as injection
| Study group | Role | What they receive |
|---|---|---|
| KOS® S | Other | An open, non-comparative, interventional single-armed clinical trial. Receives: Device: KOS® S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with at least 1-point improvement from baseline on the AIHS
Proportion of subjects with at least 1-point improvement from baseline on the AIHS (Allergan Infraorbital Hollows Scale) at month 3 after the last treatment (response rate).
Allergan Infraorbital Hollows Scale - from 0 (No visible hollowing or volume loss medially or laterally) to 4 (Defined hollowing extends from medial to lateral canthus, severe volume loss creates a marked step along the lid-cheek junction)
Measured: 3 month
Secondary outcomes (5)
Change in the AIHS from baseline
Change in the AIHS from baseline at 1, 3, 6 and 12 months after the last treatment.
Allergan Infraorbital Hollows Scale (AIHS) - from 0 (No visible hollowing or volume loss medially or laterally) to 4 (Defined hollowing extends from medial to lateral canthus, severe volume loss creates a marked step along the lid-cheek junction)
Measured: 1, 3, 6 and 12 months
Proportion of participants with at least 1-point improvement from baseline on the AIHS
Proportion of participants with at least 1-point improvement from baseline on the AIHS at 1, 6 and 12 months after the last treatment (response rates) Allergan Infraorbital Hollows Scale (AIHS) - from 0 (No visible hollowing or volume loss medially or laterally) to 4 (Defined hollowing extends from medial to lateral canthus, severe volume loss creates a marked step along the lid-cheek junction)
Measured: 1, 6 and 12 months
Change from baseline in FACE-Q Satisfaction with Eyes
Change from baseline in FACE-Q Satisfaction with Eyes scores at 1, 3, 6 and 12 months after the last treatment.
FACE-Q Satisfaction with Eyes scale: from 1 (very dissatisfied) to 4 (very satisfied)
Measured: 1, 3, 6 and 12 months
Secondary outcomes
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
Measured: 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
Measured: 2 weeks, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start13 Jun 2025
- Primary completion12 Jul 2025
- Study completion12 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Infraorbital HollowingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Medical Device (pre-market effectiveness and safety, class III)
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quantum Beauty Kozmetik
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Responsible party
- Sponsor
- Investigators
- Behnam D Bayatani, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828237
- Sponsor's protocol ID
- TGMQUA/0124/MD
- Status last verified
- Jul 2025
- First submitted
- 4 Feb 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wongprasert P, Dreiss CA, Murray G. Evaluating hyaluronic acid dermal fillers: A critique of current characterization methods. Dermatol Ther. 2022 Jun;35(6):e15453. doi: 10.1111/dth.15453. Epub 2022 Apr 5.
PubMed 35293660Attenello 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.
PubMed 25763894Fabi S, Zoumalan C, Fagien S, Yoelin S, Sartor M, Chawla S. A Prospective, Multicenter, Single-Blind, Randomized, Controlled Study of VYC-15L, a Hyaluronic Acid Filler, in Adults for Correction of Infraorbital Hollowing. Aesthet Surg J. 2021 Oct 15;41(11):NP1675-NP1685. doi: 10.1093/asj/sjab308.
PubMed 34351386
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Non-comparative Study to Evaluate the Effectiveness and Safety of the Medical Device KOS® S in the Correction of Moderate or Severe Infraorbital Hollowing
- ClinicalTrials.gov ID
- NCT06828237
- Acronym / sponsor ID
- TGMQUA/0124/MD
- Conditions
- Infraorbital Hollowing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Quantum Beauty KozmetikIndustry (pharma, biotech, devices)
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- 12 Jul 2025 (actual)
- Study completion
- 12 Jul 2025 (actual)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. These ideals prescribe specific curves, contours, dimensions, and ratios that must be achieved in order to create a face that is generally considered appealing. Additionally, dermal fillers are employed to replenish volumetric dimensions and restore a more youthful appearance to the aging face (Wongprasert et al. 2022).
Over a period of time, the convex shape of the midface region has the potential to undergo a flattening or concave transformation. The contour alterations observed can be attributed to the descent of the malar soft tissue complex from the zygoma and orbital rims in an inferomedial direction, as well as the atrophy of the malar fat pad. The malar groove, also known as the zygomatic hollow, is a linear indentation that traverses the zygoma in a diagonal manner, running parallel to the nasolabial fold.
Dermal fillers have the potential to reinstate midface volume effectively and augment malar features. The malar augmentation technique involves using dermal filler materials that provide enhanced structural support, making it an operation that is classified as advanced within the field of dermal fillers (Small, Hoang 2012).
KOS® S 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® S when used as intended.
The primary objective of the study is to evaluate the effectiveness of KOS® S in correcting "Moderate" or "Severe" infraorbital hollowing by assessing the response rate using the Allergan Infraorbital Hollows Scale (AIHS) from the baseline (Response is defined as at least 1-point improvement on the AIHS at month 3 after last treatment).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Medical Device (pre-market effectiveness and safety, class III)
| Arm | Type | Receives |
|---|---|---|
| KOS® S | Other | Device: KOS® SAn open, non-comparative, interventional single-armed clinical trial. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent by the subject
- Females and males ≥ 22 years of age
- Has "Moderate" or "Severe" infraorbital hollowing (grade 2 or 3 on the AIHS) on the 5-point AIHS for each eye as assessed by the Evaluating Investigator (i.e., both eyes must qualify but do not need to have the same score)
- 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.
Key exclusion criteria (19 listed)
- Has hyperpigmentation in the infraorbital area (does not include dark circles under the eyes, not due to hyperpigmentation).
- Has ever received permanent facial implants (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene) anywhere in the face or neck, or is planning to be implanted with any of these products during the study
- Has ever undergone fat injections above the subnasale or is planning to undergo this procedure during the study
- Has tattoos, piercings, facial hair (i.e., beard, moustache), or scars that would interfere with visual assessment of the infraorbital hollows
- Has undergone volume augmentation with semi-permanent dermal fillers (e.g., calcium hydroxyapatite, poly-L-lactic acid) or temporary dermal fillers in the malar area, temples, or around the eyes within 12 months before enrolment or is planning to undergo such treatment during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KOS® SDelivery of medical device as injection | Device | KOS® S |
Primary outcome
Proportion of subjects with at least 1-point improvement from baseline on the AIHS
Time frame: 3 month
Proportion of subjects with at least 1-point improvement from baseline on the AIHS (Allergan Infraorbital Hollows Scale) at month 3 after the last treatment (response rate). Allergan Infraorbital Hollows Scale - from 0 (No visible hollowing or volume loss medially or laterally) to 4 (Defined hollowing extends from medial to lateral canthus, severe volume loss creates a marked step along the lid-cheek junction)
5 secondary outcomes
Change in the AIHS from baseline
Time frame: 1, 3, 6 and 12 months
Proportion of participants with at least 1-point improvement from baseline on the AIHS
Time frame: 1, 6 and 12 months
Change from baseline in FACE-Q Satisfaction with Eyes
Time frame: 1, 3, 6 and 12 months
Secondary outcomes
Time frame: 1, 3, 6 and 12 months
Short- and long-term adverse effects
Time frame: 2 weeks, 6, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Background: PubMed 35293660Wongprasert P, Dreiss CA, Murray G. Evaluating hyaluronic acid dermal fillers: A critique of current characterization methods. Dermatol Ther. 2022 Jun;35(6):e15453. doi: 10.1111/dth.15453. Epub 2022 Apr 5.
- Background: PubMed 25763894Attenello 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.
- Background: PubMed 34351386Fabi S, Zoumalan C, Fagien S, Yoelin S, Sartor M, Chawla S. A Prospective, Multicenter, Single-Blind, Randomized, Controlled Study of VYC-15L, a Hyaluronic Acid Filler, in Adults for Correction of Infraorbital Hollowing. Aesthet Surg J. 2021 Oct 15;41(11):NP1675-NP1685. doi: 10.1093/asj/sjab308.
- Champely, S. (2020). pwr: Basic Functions for Power Analysis. R package version 1.3-0.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Behnam D Bayatani study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KOS® S in people with Infraorbital Hollowing, run by Quantum Beauty Kozmetik at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with at least 1-point improvement from baseline on the AIHS (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06828237, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.