Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06378086
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-04-17
Brief Title:
RHA Redensity With New Anesthetic Agent Perioral Rhytids PAS
Sponsor:
Teoxane SA
Organization:
Teoxane SA
Study Overview
Official Title:
A Randomized Controlled Double-blinded Within-subject Split-face Multicenter Prospective Clinical Study to Compare the Level of Pain Using the Dermal Filler RHA Redensity Formulated With Two Different Anesthetics in the Treatment of Perioral Rhytids
Status:
NOT_YET_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 randomized controlled double-blinded within-subject split-face multicenter prospective study to investigate whether RHA Redensity with new anesthetic agent is non-inferior to RHA Redensity with lidocaine in terms of injection site pain felt by the subject during injection
At screening the Principal Investigator PI evaluated subjects perioral rhytid severity using the Perioral Rhytid Severity Rating Scale PR-SRS to confirm eligibility and to establish a pre-treatment score for assessing aesthetic improvement
At Visit 1 RHA Redensity with new anesthetic agent was administered in a random sequence first or second injection and side of the mouth left or right and RHA Redensity with lidocaine was administered to the other side Study subjects and the PI injecting study devices were blinded
Immediately after injection of an upper perioral quadrant subjects rated the injection site pain experienced during injection using a 100 mm Visual Analog Scale VAS Injection site pain in each side of the mouth was also assessed at 15 30 45 and 60 minutes after injection of the upper quadrant
Safety evaluation consisted of AE assessments a 30-day CTR Common Treatment Response diary and a follow-up call performed by the study site at 72 hours after injection
Subjects attended Visit 2 30 days post-injection where effectiveness and safety assessments were conducted
Subjects who presented with an unresolved clinically significant device related AE at Visit 2 received a optional follow-up phone call no later than 30 days after Visit 2
If the clinically significant AE remained unresolved the Investigator requested that the subject attended the optional in-clinic follow-up visit ie Visit 3 within 5 working days Follow-up of the clinically significant AE continued until the AE was resolved or the TI determines that additional follow-up was not necessary
At screening the Principal Investigator PI evaluated subjects perioral rhytid severity using the Perioral Rhytid Severity Rating Scale PR-SRS to confirm eligibility and to establish a pre-treatment score for assessing aesthetic improvement
At Visit 1 RHA Redensity with new anesthetic agent was administered in a random sequence first or second injection and side of the mouth left or right and RHA Redensity with lidocaine was administered to the other side Study subjects and the PI injecting study devices were blinded
Immediately after injection of an upper perioral quadrant subjects rated the injection site pain experienced during injection using a 100 mm Visual Analog Scale VAS Injection site pain in each side of the mouth was also assessed at 15 30 45 and 60 minutes after injection of the upper quadrant
Safety evaluation consisted of AE assessments a 30-day CTR Common Treatment Response diary and a follow-up call performed by the study site at 72 hours after injection
Subjects attended Visit 2 30 days post-injection where effectiveness and safety assessments were conducted
Subjects who presented with an unresolved clinically significant device related AE at Visit 2 received a optional follow-up phone call no later than 30 days after Visit 2
If the clinically significant AE remained unresolved the Investigator requested that the subject attended the optional in-clinic follow-up visit ie Visit 3 within 5 working days Follow-up of the clinically significant AE continued until the AE was resolved or the TI determines that additional follow-up was not necessary
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None