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New injectable filler aims to smooth wrinkles and restore facial volume

NCT ID NCT06872359

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new injectable filler called KIO017 in 210 healthy adults who want to improve their facial appearance. The filler is designed to add volume to areas like the cheeks, lips, and jawline, and to reduce wrinkles. Researchers will measure how well it works using a standard improvement scale and track any side effects to ensure it is safe.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 210 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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: 1. anti-inflammatory medication and/or antihistamines within 2 weeks prior to injection, and 1 month post-injection 2. corticosteroids within 1 month prior to injection, and 1-month post-injection 3. 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)

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Centrum Medyczne "Tu Sie Leczy"

    Gdansk, 80-280, Poland

  • Eurofins Dermscan Pharmascan

    Aix-en-Provence, 13594, France

  • Eurofins Dermscan Pharmascan

    Villeurbanne, 69100, France

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