Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06533540
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Safety Study of TPX-121 on Nasolabial Folds
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single-center Single Group Dose Escalation Phase 1 Clinical Trial to Investigate the Safety of TPX-121 in Subjects With Moderate-to-Extreme Nasolabial Folds
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Nasolabial folds augmentation is possible through dermal filler and botulinum toxin however safety issues are existed as well as efficacy Therefore there is a need for a safer procedure for nasolabial folds correction This study Project No TPX-121 assesses the safety of allogeneic fibroblasts TPX-115 on nasolabial folds The safety endpoint is dose-limiting toxicity DLT In addition exploratory endpoints are the improvement of nasolabial folds in Wrinkle Severity Rating Scale WSRS at week 4 and 12 change in WSRS and Wrinkle Severity Scale WSS at week 4 and 12 and overall appearance improvement rate in Global Aesthetic Improvement Scale GAIS at week 4 and 12
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None