Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2025-12-24 @ 2:45 PM
Study NCT ID:
NCT06872359
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-08
First Post:
2025-02-27
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Performance and Safety of Injectable KIO017 Device Range for Facial Tissue Filling
Sponsor:
Kiomed Pharma
Organization:
Study Overview
Official Title:
Prospective, Multicentric, Open Label Clinical Investigation to Evaluate Performance and Safety of Injectable KIO017 Device Range for Facial Tissue Filling
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LITCHEE
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: