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Dermal FillersLITCHEENCT06872359

Evaluation of Performance and Safety of Injectable KIO017 Device Range for Facial Tissue Filling

A study testing KIO017-1, KIO017-2 and KIO017-3 in people with Dermal Fillers and Cheek Augmentation, run by Kiomed Pharma at 3 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this clinical trial is to primarily evaluate the performance of KIO017 in filling/volumizing after injection in different areas in healthy women or men, older than 18 years and seeking an improvement of her/his face aspect with resorbable filler. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
KIO017-1, KIO017-2 and KIO017-3
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
3 sitesin 2 countries
Study dates
25 Mar 2025to 7 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy Subject
  • Sex: male or female
  • Age: more than 18 years
  • Subject seeking an improvement of her/his face aspect with resorbable filler
  • The subjects must meet a criterion according to the treatment indication specific scale (Asher Face Volume Loss Scale (FVLS), Bazin Ptosis of the Lower part of the Face Scale (PLFS), temple hollow scale (THS), Wrinkle Severity Rating Scale (WSRS), Bazin Marionette Lines scale (MLS), Bazin Upper Lip Wrinkle Scale (ULWS), Rossi scale)
  • Subject having given their free, express, and informed consent
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  • Subject psychologically able to understand the information related to the study, and to give their written informed consent
  • Subject affiliated to a health social security system
  • Women of childbearing potential should use a contraceptive method considered effective since at least 12 weeks and throughout the study
  • Women of childbearing potential must have a negative urinary pregnancy test on D0

Who cannot join

  • Pregnant or nursing woman or planning a pregnancy during the study.
  • Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship
  • Subject in a social or sanitary establishment
  • Subject participating to another clinical research or being in an exclusion period for a previous study
  • In France: subject having received 6000 euros indemnities for participation in clinical research in the 12 previous months, including participation in the present study
  • Subject already included in another group of this study
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  • Subject having received treatment with a laser, ultrasound or radiofrequency treatment, a dermabrasion, a surgery, a chemical peeling or any other procedure based on active dermal response on the face in the 6 previous months
  • Subject having received mesotherapy products or botulinum toxin in the same area in the 6 previous months
  • Subject having received resorbable filling product (e.g., hyaluronic acid) injections in the same area in the 12 previous months
  • Subject having received slowly resorbable filling product (e.g., calcium hydroxyapatite, polycaprolactone, polylactic acid) injections in the same area or resorbable threads in the 24 previous months
  • Subject having received injections of permanent products in the face (e.g., acrylate polymers, silicone, polytetrafluoroethylene)
  • Subject having received facial or cervico-facial lifting in the 24 previous months
  • Subject wearing skin support device (mesh, gold threads, permanent lifting threads) on the face
  • Subject with uncontrolled and/or recently recovered (<6 months) depression or psychiatric disorders or any other disorder that may pose a health risk to the subject in the study and/or may have an impact on the study assessments
  • Subject with severe, ongoing and uncontrolled diseases such as malignancy or history of malignancy, type I diabetes, liver failure, renal failure, lung/heart disease, neoplasia, malignant blood disease, HIV, or other major disease (e.g., systemic fungal infection)
  • Subject with recurrent porphyria, untreated epilepsy, coronary insufficiency, ventricular rhythm disorders, severe hypertension, obstructive cardiomyopathy, hyperthyroidism
  • Subject with any skin or systemic disease (acute and/or chronic), in the previous year, likely to interfere with the measured parameters or to put the subject to an undue risk
  • Subject with known history of or suffering from autoimmune disease and/or immune deficiency
  • Subject with current cutaneous inflammatory or infectious processes (e.g., acne, herpes, mycosis, papilloma, chronic eczema, atopic dermatitis …), abscess, unhealed wound, or a cancerous or precancerous lesion on the face
  • Subject with multiple allergies, anaphylactic shock history, evolutive allergic pathologies, history of granulomatous diseases
  • Subject with known hypersensitivity to chlorhexidine
  • Subject having history of allergy or hypersensitivity to one of the components of the tested device, like hyaluronic acid, lidocaine or other amine-type local anaesthetics. polysaccharides of edible mushrooms
  • Subject predisposed to keloids or hypertrophic scarring
  • Subject with coagulation and/or homeostasis disorders
  • Subject with evidence of lymphatic or venous stasis or serious blood disorders
  • Subject with pigmentation disorders
  • Subject with history of Streptococcus disease (recurrent sore throats, acute rheumatic fever)
  • Subjects with congenital methemoglobinemia or receiving concomitant treatment with methaemoglobin-inducing agents
  • For subject injected in the chin: subject with clinically significant malocclusion (severe overbite), having dentures and/or any device covering the palate that would interfere with visual assessment of the chin area
  • Subject with tattoos, piercings, facial hairs mole or scar that would interfere with visual assessment on the injected area
  • Subject with symptoms consistent with COVID-19 or suffering from ongoing symptoms from previous COVID-19 infection
  • Subject under anti-coagulant treatment (such as aspirin, nonsteroidal anti-inflammatory drugs) or treatment liable to interfere with the healing process or hemostasis, within 1 month prior to injection, and one-month post-injection.
  • Subject with a treatment that reduces or inhibits hepatic metabolism (cimetidine, beta-blockers, etc..)
  • Subject having received a vaccine within 21 days prior to injection or planning to do in the 14 days post-injection
  • Subject having received dental care within 6 weeks prior to the study or planning to have dental care within 6 weeks post-injection
  • Subject receiving any treatment that, in the opinion of the clinical investigator, may interfere with test results or put the subject to undue risk
  • Subject undergoing a topical (on the face) or systemic treatment:
  • anti-inflammatory medication and/or antihistamines within 2 weeks prior to injection, and 1 month post-injection
  • corticosteroids within 1 month prior to injection, and 1-month post-injection
  • retinoids and/or immunosuppressors within 3 months prior to injection and during the study
  • Intensive exposure to sunlight or UV-rays within the previous month and/or planning to do so during the study
  • Heavy smoker (subject who reports smoking 10 or more cigarettes per day);
  • Subject with an excessive consumption of alcohol (more than 2 glasses of wine per day)

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

France2 sites

  • Eurofins Dermscan Pharmascan

    Aix-en-Provence, 13594

  • Eurofins Dermscan Pharmascan

    Villeurbanne, 69100

Other trials in France

Poland1 site

  • Centrum Medyczne "Tu Sie Leczy"

    Gdansk, 80-280

Other trials in Poland

About this study

Official title: Prospective, Multicentric, Open Label Clinical Investigation to Evaluate Performance and Safety of Injectable KIO017 Device Range for Facial Tissue Filling

The goal of this clinical trial is to primarily evaluate the performance of KIO017 in filling/volumizing after injection in different areas in healthy women or men, older than 18 years and seeking an improvement of her/his face aspect with resorbable filler. The main questions it aims to answer are:

If the products are safe

Read more
  • Acceptable local tolerance, with acceptable clinical signs after injection.

If the clinical performance is as intended compared to baseline

  • Evaluation of performance by assessing the improvement of the appearance of the defect to be corrected by using Global Aesthetic Improvement Scale (GAIS)
  • Quantification of the improvement using the appropriate scale when available or other appropriates tool (angle for chin, for instance).
  • Pain felt during injection and after injection
  • Subject satisfaction
Being tested
KIO017-1, KIO017-2, KIO017-3
Keywords
Filler, Carboxymethyl chitosan, Hyaluronic acid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KIO017-1Device

    Subcutaneous and/or supraperiostal injections in chin and/or mid-face and/or jawline. One (1) injection session on D0 and one (1) touch-up session on M1. The total volume injected per face and per session will not exceed 8 ml.

  • KIO017-2Device

    Subcutaneous injections in temples and/or nasolabial folds and/or marionette lines and/or mid-face. One (1) injection session on D0 and one (1) touch-up session on M1. The total volume injected per face and per session will not exceed 8 ml.

  • KIO017-3Device

    Injections in or around labial mucosa for lip volume and contour and/or intradermal injections in perioral lines. One (1) injection session on D0 and one (1) touch-up session on M1. The total volume injected per face and per session will not exceed 8 ml.

Study groups in NCT06872359
Study groupRoleWhat they receive
Group 1 (KIO017-1)ExperimentalSubject seeking an improvement in at least one of the following indications: chin retrusion, mid-face deficit, jawline ptosis
Receives: Device: KIO017-1
Group 2 (KIO017-2)ExperimentalSubject seeking an improvement in at least one of the following indications: temple volume deficit, moderate to severe nasolabial folds, moderate to severe marionette lines, mid-face deficit
Receives: Device: KIO017-2
Group 3 (KIO017-3)ExperimentalSubject seeking an improvement in lip volume/contour and/or perioral lines.
Receives: Device: KIO017-3

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of improvement of KIO017 device range on GAIS (Global Aesthetic Improvement Scale)

    Proportion of indications having an improvement with the overall KIO017 range of devices as assessed by the investigator in live using the GAIS (in 5 points from "worse" (5) to very much improved" (1))

    Measured: The measurement is performed on Month 3 after the injection

  2. Assessment of Safety

    Assessment of number and percentage of subjects with Adverse Device Effects (ADEs). ADEs are defined as any adverse event related to the use of the investigational medical device.

    Measured: Evaluation is performed on the Month 1 after injection.

Secondary outcomes (20)

  1. Assessment of proportion of indications having an improvement on GAIS (Global Aesthetic Improvement Scale) by the investigator in live

    Proportion of indications having an improvement with the overall KIO017 range of devices as assessed by the investigator in live using the GAIS (in 5 points from "worse" (5) to very much improved" (1))

    Measured: Measurement of improvement after injection on the Month 1, Month 6, Month 9, Month 12, Month 18 and Month 24

  2. Assessment of each product and proportion of indications having an improvement on GAIS (Global Aesthetic Improvement Scale) by the investigator in live

    For each product, proportion of indications having an improvement with each KIO017 device as assessed by the investigator in live using the GAIS (in 5 points from "worse" (5) to very much improved" (1))

    Measured: Measurement of improvement after injection on the Month 1, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24

  3. Assessment of each indication and proportion of subjects having an improvement on GAIS (Global Aesthetic Improvement Scale) by the investigator in live

    For each indication, proportion of subjects having an improvement with each KIO017 device as assessed by the investigator in live using the GAIS (in 5 points from "worse" (5) to very much improved" (1))

    Measured: Measurement of improvement after injection on the Month 1, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24

  4. Assessment of proportion of indications having an improvement on GAIS (Global Aesthetic Improvement Scale) by the subject in live

    Proportion of indications having an improvement with the overall KIO017 range of devices as assessed by the subject in live using the GAIS (in 5 points from "worse" (5) to very much improved" (1))

    Measured: Measurement of improvement after injection on the Month 1, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24

  5. Assessment of each product, proportion of indications having an improvement on GAIS (Global Aesthetic Improvement Scale) by the subject in live

    For each product, proportion of indications having an improvement with each KIO017 device as assessed by the subject in live using the GAIS (in 5 points from "worse" (5) to very much improved" (1))

    Measured: Measurement of improvement after injection on the Month 1, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24

  6. Assessment of each indication, proportion of subjects having an improvement on GAIS (Global Aesthetic Improvement Scale) by the subject in live

    For each indication, proportion of subjects having an improvement with each KIO017 device as assessed by the subject in live using the GAIS (in 5 points from "worse" (5) to very much improved" (1))

    Measured: Measurement of improvement after injection on the Month 1, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24

  7. Assessment of improvement on Bazin Ptosis of the Lower part of the Face Scale (PLFS)

    Change from baseline and proportion of subjects with improvement based on Bazin Ptosis of the Lower part of the Face Scale (PLFS) for the subjects injected in jawline with KIO017-1 (in 6 grades: from grade 0 to grade 5)

    Measured: Measurement of change/proportion of subjects with improvement after injection on the Month 1, Month 3, Month 6, Month 12, Month 18 and Month 24

  8. Assessment of the improvement via glabella-subnasal-pogonion facial angle

    Change from baseline and proportion of subjects with improvement based on glabella-subnasal-pogonion facial angle for the subjects injected in chin with KIO017-1

    Measured: Measurement of change/proportion of subjects with improvement after injection on the Month 1, Month 3, Month 6, Month 12, Month 18 and Month 24

  9. Assessment of improvement on Ascher Face Volume Loss Scale (FVLS)

    Change from baseline and proportion of subjects with improvement based on Ascher Face Volume Loss Scale (FVLS) for subjects injected in mid-face with KIO017-1 or KIO017-2 (in 5 grades: from grade 1 to grade 5)

    Measured: Measurement of change/proportion of subjects with improvement after injection on the Month 1, Month 3, Month 6, Month 12, Month 18 and Month 24

  10. Assessment of improvement on Temple Hollow Scale (THS)

    Change from baseline and proportion of subjects with improvement based on a descriptive Temple Hollow Scale (THS) for subjects injected in temples with KIO017-2 (in 5 grade: from grade 0 to grade 4)

    Measured: Measurement of change/proportion of subjects with improvement after injection on the Month 1, Month 3, Month 6, Month 12, Month 18 and Month 24

  11. Assessment of improvement on Wrinkle Skin Rating Scale (WSRS)

    Change from baseline and proportion of subjects with improvement based on a Wrinkle Skin Rating Scale (WSRS) for subjects injected in nasolabial folds with KIO017-2 (in 5 grades: from from 1 to grade 5)

    Measured: Measurement of change/proportion of subjects with improvement after injection on the Month 1, Month 3, Month 6, Month 12, Month 18 and Month 24

  12. Assessment of improvement on Bazin Marionette Lines Scale (MLS)

    Change from baseline and proportion of subjects with improvement based on a Bazin Marionette Lines Scale (MLS) for subjects injected in marionette lines with KIO017-2 (in grade 7: from grade 0 to grade 6)

    Measured: Measurement of change/proportion of subjects with improvement after injection on the Month 1, Month 3, Month 6, Month 12, Month 18 and Month 24

  13. Assessment of improvement on Rossi scale

    Change from baseline and proportion of subjects with improvement based on a Rossi scale for subjects injected in lips with KIO017-3 (in grade 5: from grade 1 to grade 5)

    Measured: Measurement of change/proportion of subjects with improvement after injection on the Month 1, Month 3, Month 6, Month 9, Month 12 (for upper lip and lower lip)

  14. Assessment of performance on Bazin Upper Lip Wrinkle Scale (ULWS)

    Change from baseline and proportion of subjects with improvement based on a Bazin Upper Lip Wrinkle Scale (ULWS) for subjects injected in perioral lines with KIO017-3 (in grade 7: from grade 0 to grade 6)

    Measured: Measurement of change/proportion of subjects with improvement after injection on the Month 1, Month 3, Month 6, Month 9 and Month 12

  15. Assessment of average pain on Visual Analog Scale (VAS)

    Assessment of average pain felt by the subjects during each injection session using a 0-100 mm VAS

    Measured: One hour after the last injection and each day for two days after each injection session

  16. Assesmment of injector satisfaction via questionnaire

    Description in percentages of injector's satisfaction on the injection and instruction for use quality using a questionnaire (in grade 5: from "very satisfied" to "very dissatisfied")

    Measured: Questionnaire completed immediately after each injection session: Day 0, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24

  17. Assessment of subject satisfaction via questionnaire

    Description in percentages of satisfaction of the subjects with the treatment using a subjective evaluation questionnaire

    Measured: On Day 0 before the injection and at each timepoint: Month 1, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24

  18. Assessment of local tolerance on Injection Site Reactions (ISRs) scale reported by the subjects

    Description of the number, maximum severity and duration of ISRs reported by the subjects (in 4 grade: from grade 0 to grade 3)

    Measured: During one month after each injection session on the daily-log: Day 0, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24

  19. Assessment of local tolerance on Injection Site Reactions (ISRs) scale evaluated by the investigator

    Description of ISRs evaluated by the investigator (in 4 grade: from grade 0 to grade 3)

    Measured: On Day 0 after the injection and after each injection session: on Month 1, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24

  20. Number of AEs (Adverse Effects) and ADEs (Adverse Device Effects)

    Collection of AEs (Adverse Effects) and ADEs (Adverse Device Effects)

    Measured: From the first injection and till the Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2025
  2. Study start25 Mar 2025
  3. Primary completion9 Dec 2025
  4. Study completion7 Sep 2027 (estimated)

Resources

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
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06872359
Sponsor's protocol ID
24-1174-U5
Acronym
LITCHEE
Status last verified
May 2026
First submitted
27 Feb 2025
Last updated
6 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing KIO017-1, KIO017-2 and KIO017-3 in people with Dermal Fillers and Cheek Augmentation, run by Kiomed Pharma at 3 sites in 2 countries.

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 10 inclusion and 43 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: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France, Poland. 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?

This study is still under way. Results are not available in the source record yet.

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?

Assessment of improvement of KIO017 device range on GAIS (Global Aesthetic Improvement Scale) (time frame: The measurement is performed on Month 3 after the injection). The study lists 2 primary outcomes in all. 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 NCT06872359.

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 6 May 2026.

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