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

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
• Volume Loss of the Jawline
• Jawline Definition
• Contouring
• Midface Contour Deficiencies
• Nasolabial Fold Improvement
• Nasolabial Folds Correction
• Facial Wrinkles
• Facial Rhytides

Interventions

DEVICE

KIO017-1

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.

DEVICE

KIO017-2

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.

DEVICE

KIO017-3

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.

Sponsors & Collaborators

• Eurofins Dermscan Pharmascan

  collaborator INDUSTRY

• Kiomed Pharma

  lead INDUSTRY

Principal Investigators

• Siham Rharbaoui, Dr · Eurofins Dermscan Pharmascan

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-03-25

Primary Completion

2025-12-09

Completion

2027-09-07

Countries

• France
• Poland

Study Locations