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

NCT06872359 | Active Not Recruiting

• 1 other identifier: 24-1174-U5
• Study Type: interventional
• Target: 210
• Locations: 2 countries
• Sites: 3

Brief 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

Conditions

Dermal Fillers; Cheek Augmentation; Lip Augmentation; Perioral Rhytids; Mid-facial Volume Deficit Related to Aging; Lip Enhancement; Lip Augmentation and Correction of Perioral Rhytids; Volume Deficiency in the Mid-Face; Midface Contour Deficiencies; Nasolabial Fold Improvement; Nasolabial Folds Correction; Facial Wrinkles; Facial Rhytides; Volume Loss of the Jawline; Jawline Definition; Contouring

Keywords

Filler; Carboxymethyl chitosan; Hyaluronic acid

Outcome Measures

Primary Outcomes (2)

• 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))

  The measurement is performed on Month 3 after the injection

• 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.

  Evaluation is performed on the Month 1 after injection.

Secondary Outcomes (20)

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

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

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

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

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

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

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

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

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

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

Study Arms (3)

Group 1 (KIO017-1)

EXPERIMENTAL

Subject seeking an improvement in at least one of the following indications: chin retrusion, mid-face deficit, jawline ptosis

Device: KIO017-1

Group 2 (KIO017-2)

EXPERIMENTAL

Subject 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

Device: KIO017-2

Group 3 (KIO017-3)

EXPERIMENTAL

Subject seeking an improvement in lip volume/contour and/or perioral lines.

Device: KIO017-3

Interventions

KIO017-1 DEVICE

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.

Group 1 (KIO017-1)

KIO017-2 DEVICE

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.

Group 2 (KIO017-2)

KIO017-3 DEVICE

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.

Group 3 (KIO017-3)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Kiomed Pharma: lead
• Eurofins Dermscan Pharmascan: collaborator

Study Sites (3)

Eurofins Dermscan Pharmascan

Aix-en-Provence, 13594, France

Location

Eurofins Dermscan Pharmascan

Villeurbanne, 69100, France

Location

Centrum Medyczne "Tu Sie Leczy"

Gdansk, 80-280, Poland

Location

Study Officials

• Siham Rharbaoui, Dr

  Eurofins Dermscan Pharmascan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 12, 2025
• Study Start: March 25, 2025
• Primary Completion: December 9, 2025
• Study Completion (Estimated): September 7, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

FR (2); PL (1)