Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04754646
Status:
COMPLETED
Last Update Posted:
2023-03-09
First Post:
2021-02-08
Brief Title:
RHA 4 NLF Cannula
Sponsor:
Teoxane SA
Organization:
Teoxane SA
Study Overview
Official Title:
A Randomized Controlled Single-blinded Within-subject Split-face Multicenter Prospective Clinical Study to Evaluate the Effectiveness and Safety of Using the Dermal Filler RHA4 Injected With a Cannula or With a Sharp Needle for the Treatment of Moderate to Severe Nasolabial Folds
Status:
COMPLETED
Status Verified Date:
2023-03
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 single-blinded within-subject split-face multicenter prospective study to investigate whether RHA4 injected in NLFs with a cannula is non-inferior to RHA4 injected in NLFs with a sharp needle 27G x ½ for the correction of moderate to severe NLFs as determined by the Blinded Live Evaluator BLE using the Teoxyne NLF-WSRS proprietary validated NLF Wrinkle Severity Rating Scale at 12 weeks from last treatment
At Visit 1 Week 0 RHA4 injected with cannula will be administered in a random sequence first or second injection and side of the face left or right NLF and RHA4 injected with a sharp needle will be administered to the other side The TI will administer study devices and will be unblinded to treatment allocation Blinded assessments of effectiveness will be conducted by the BLE Blinded Live Evaluator
4 weeks following initial treatment subjects will attend Visit 2 and receive if necessary touch-up treatments using a needle or cannula as per the subjects initial treatment assignment
Subjects receiving touch-up treatments at Week 4 Visit 2 will attend a new Visit 2b 4 weeks following touch-up treatment subject not receiving touch-up treatment will not attend Visit 2b
After each injection initial treatment or touch-up subjects will receive a safety follow-up call from the study site within 3-day
Subjects will then attend scheduled in-office study visits at 8 Visit 3 and 12 weeks Visit 4 following last treatment initial treatment or touch-up where safety and effectiveness assessments will be conducted
At Visit 1 Week 0 RHA4 injected with cannula will be administered in a random sequence first or second injection and side of the face left or right NLF and RHA4 injected with a sharp needle will be administered to the other side The TI will administer study devices and will be unblinded to treatment allocation Blinded assessments of effectiveness will be conducted by the BLE Blinded Live Evaluator
4 weeks following initial treatment subjects will attend Visit 2 and receive if necessary touch-up treatments using a needle or cannula as per the subjects initial treatment assignment
Subjects receiving touch-up treatments at Week 4 Visit 2 will attend a new Visit 2b 4 weeks following touch-up treatment subject not receiving touch-up treatment will not attend Visit 2b
After each injection initial treatment or touch-up subjects will receive a safety follow-up call from the study site within 3-day
Subjects will then attend scheduled in-office study visits at 8 Visit 3 and 12 weeks Visit 4 following last treatment initial treatment or touch-up where safety and effectiveness assessments will be conducted
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?:
None
Is an FDA AA801 Violation?:
None