|
|
| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P040024 S142/ PAS001 |
| Date Original Protocol Accepted |
12/23/2025
|
| Date Current Protocol Accepted |
12/23/2025
|
| Study Name |
Post-Approval Study
|
| Device Name |
Restylane® Lyft with Lidocaine
|
| Clinical Trial Number(s) |
NCT05777759
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
To evaluate the safety of Restylane Lyft with Lidocaine for augmentation of the chin region 3 months after retreatment.
|
| Study Population |
A total of 100 adult male and female subjects aged 22 years or older with the intent to undergo treatment of the chin region to improve the chin profile is planned to be included in this study.
|
| Sample Size |
Number of subjects: 100
Assumptions for sample size estimation: No sample size calculation has been performed.
Number of sites: approximately 8
Sites location: United states of America
|
| Key Study Endpoints |
Safety Endpoints
Primary: Treatment-emergent adverse events (TEAEs) that are related to the device and/or injection procedure after the Month 12 optional retreatment.
Secondary: To evaluate the safety of Restylane Lyft with Lidocaine for augmentation of the chin region to improve the chin profile up to 3 months after retreatment, for the defined endpoints:
• To evaluate the incidence, intensity, time to onset, and duration of adverse events (AEs) collected throughout the study period.
• To evaluate pre-defined, expected, post-treatment events reported for 28 days from each treatment as recorded in the subject diary.
• Subject pain assessment before (prior to application of any anesthetic) and immediately after (before any post-injection therapy is provided, e.g., ice packs) treatment, using an 11-point Numeric Pain Scale (NPS).
Effectiveness Endpoints
Primary:
Secondary: To evaluate the effectiveness of Restylane Lyft with Lidocaine for augmentation of the chin region
to improve the chin profile, for the defined endpoints:
• Binary responder status variables (Yes/No) indicating whether a subject has at least 1 grade improvement from Baseline based on the Treating Investigator’ live assessment of the Galderma Chin
Retrusion Scale (GCRS) at 3, 6, 9, 12 and 15 months after initial treatment to optimal correction.
• Binary responder status variables (Yes/No) indicating whether a subject has at least “Improved”
(Improved, Much Improved or Very Much Improved) on the Global Aesthetic Improvement Scale
(GAIS) as assessed by the Subject and Treating Investigator separately at 3, 6, 9, 12 and 15 months
after initial treatment to optimal correction.
• Subject satisfaction with chin projection and shape at 3, 6, 9, 12 and 15 months, using the Subject Satisfaction
Questionnaire (SSQ).
|
| Follow-up Visits and Length of Follow-up |
72-hour telephone call after initial treatment/ visit 2 (+/-24 hours)
14 days after initial treatment /visit 2a (+7 days)
1 month after initial treatment (+7 days) – (Optional touch-up visit /visit 3
72-hour telephone call after touch-up / Visit 3a (+/-24 hours)
14 days after touch-up / Visit 3b (+7 days)
Month 1 after optional touch-up / Visit 3c (+7 days)
3, 6, and 9 months after last treatment (+/-14 days) Visits 4-6
12 months after last treatment (+14 days) - Optional retreatment visit
72-hour telephone call/Visit 7a (+/-24 hours)
14 days after retreatment/Visit 7b (+7 days)
Month 1 after optional retreatment / Visit 7c (+7 days)
Month 15 (end of study, EOS visit) / Visit 8 (+/-14 days)
|
