Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06367634
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-11
Brief Title:
TEOSYAL PureSense ULTRA DEEP Versus Restylane Lidocaine for the Correction of Moderate to Severe Nasolabial Folds in Chinese Adults
Sponsor:
Teoxane SA
Organization:
Teoxane SA
Study Overview
Official Title:
A Prospective Multi-Center Randomized Controlled Subject- and Evaluator-Blinded Non-Inferior Clinical Investigation of the Safety and Effectiveness of TEOSYAL PureSense ULTRA DEEP Versus Restylane Lidocaine for the Correction of Moderate to Severe Nasolabial Folds in Chinese Adults
Status:
RECRUITING
Status Verified Date:
2024-04
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:
This is a prospective multi-center randomized controlled subject- and evaluator-blinded clinical investigation to demonstrate non-inferiority of TEOSYAL PureSense ULTRA DEEP compared to Restylane Lidocaine for the correction of moderate to severe NLF in Chinese adults
Eligible subjects will be enrolled and randomized either to the treatment group or control group in a 11 ratio on Day 0 Each subject assigned to the treatment group will receive TEOSYAL PureSense ULTRA DEEP in both NLFs whereas subjects assigned to the control group will receive Restylane Lidocaine
The treating investigator will administer the corresponding product in both NLFs of the subject on Day 0
All subjects will return to the site at 4 12 24 36 and 52 weeks after the last treatment for effectiveness and safety assessment All subjects will receive a safety phone call 7 days after the initial treatment at baseline and after the touch-up treatment if applicable
Eligible subjects will be enrolled and randomized either to the treatment group or control group in a 11 ratio on Day 0 Each subject assigned to the treatment group will receive TEOSYAL PureSense ULTRA DEEP in both NLFs whereas subjects assigned to the control group will receive Restylane Lidocaine
The treating investigator will administer the corresponding product in both NLFs of the subject on Day 0
All subjects will return to the site at 4 12 24 36 and 52 weeks after the last treatment for effectiveness and safety assessment All subjects will receive a safety phone call 7 days after the initial treatment at baseline and after the touch-up treatment if applicable
Detailed Description:
None
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