|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P170002 S026/ PAS001 |
| Date Original Protocol Accepted |
12/13/2023
|
| Date Current Protocol Accepted |
10/18/2024
|
| Study Name |
TEO-PAS-2302
|
| Device Name |
RHA® Redensity Mepi, RHA®2 Mepi, RHA®3 Mepi, RHA®4 Mepi
|
| General Study Protocol Parameters |
| Study Design |
Randomized Clinical Trial
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: At least 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a randomized, controlled, double-blinded, within-subject (split-face), multicenter, prospective study to investigate whether RHA1-M with mepivacaine is non-inferior to RHA1 with lidocaine in terms of injection site pain felt by the subject during injection
|
| Study Population |
Adults 22 years of age or older; cohort will include at least 10% of Fitzpatrick Skin Types V & VI
|
| Sample Size |
20
|
| Key Study Endpoints |
The primary endpoint is injection site pain during injection into the upper perioral rhytids assessed immediately following injection with RHA1-M with mepivacaine (using a 100 mm VAS) compared to the injection site pain felt during injection into the contralateral upper perioral rhytids assessed immediately following injection(s) with RHA1 with lidocaine.
Safety endpoints: Adverse events; visual assessment, neurological assessment, lip functionality
|
| Follow-up Visits and Length of Follow-up |
The follow-up will be for 30-65 days
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
20
|
| Actual Number of Sites Enrolled |
3
|
| Patient Follow-up Rate |
100%
|
| Final Safety Findings |
The clinical evaluation of RHA Redensity formulations containing either lidocaine or mepivacaine demonstrated consistently favorable safety profiles, with no significant differences observed between the two anesthetic options including for subjects with FST V and VI. Both products were well tolerated across all study populations, with no reported deaths, serious adverse events (SAEs), unexpected adverse device effects (UADEs), or study withdrawals due to adverse events (AEs) or adverse device effects (ADEs). No adverse events of special interest (AESIs) were identified.
|
| Final Effect Findings |
The study results demonstrated that RHA Redensity with mepivacaine (RHA Redensity Mepi) was non-inferior to RHA Redensity with lidocaine in terms of reducing injection pain.
|
| Study Strengths & Weaknesses |
N/A
|
| Recommendations for Labeling Changes |
To update the labeling to integrate the Post Approval Study results for subjects with Fitzpatrick V and VI in effectiveness and safety sections.
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