Active — Not RecruitingNot Applicable

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

France, Poland210 participantsStarted 2025-03-25

Plain-language 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. The main questions it aims to answer are: If the products are safe \- 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Assessment of Safety

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

Trial details

NCT IDNCT06872359

SponsorKiomed Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-09

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