Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06336044
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-03-14
Brief Title:
Pre-marketing Clinical Trial to Evaluate the Safety and Efficacy of the Filler of Hyaluronic Acid Recombinant Collagen
Sponsor:
Taumedika srl
Organization:
Taumedika srl
Study Overview
Official Title:
Pre-marketing Clinical Trial to Evaluate the Safety and Efficacy of the Voluming Filler Based on Hyaluronic Acid Recombinant Collagen
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
Study to validate the safety and efficacy of the Hyaluronic Acid Collagen filler 20 patients will undergo through 3 visits one to asses the health and apply the filler one after 4 weeks to check the results one after 16 weeks for the final check and results validation Safety assessed with analysis of the Adverse Events
Detailed Description:
The patients chosen with facial laxity characteristics at the first visit will be assessed and will receive the treatment microinjections in the cheekbone area over the lips and in the marionette lines After 4 weeks the first visit will assess the change of the tissutal structure with non invasive measurements
Study Oversight
Has Oversight DMC:
None
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?:
None