Clinical Trial

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

Study acronym: LITCHEE
Active, Not Recruiting
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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
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-03-06; most recent amendment 2026-05-05.
Status change: Not Yet Recruiting → Active, Not Recruiting 2025-09-01
Trial Details
NCT Number NCT06872359
Lead Sponsor Kiomed Pharma
Collaborators: Eurofins Dermscan Pharmascan
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 +8 more
Enrollment 210 participants
Start Date 2025-03-25
Primary Completion 2025-12-09 (estimated)
Study Completion 2027-09-07 (estimated)
Updated on ClinicalTrials.gov 2026-05-06