Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study's main purpose is to evaluate the overall aesthetic improvement of the treated areas by treatment group, as assessed by the Investigator.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restylane Shaype | Experimental | Participants will receive Restylane Shaype in the chin area only. |
|
| Restylane Shaype with Restylane Defyne | Other | Participants will receive Restylane Shaype in the chin area and Restylane Defyne in the marionette line areas laterally to the chin. |
|
| Restylane Shaype with Restylane Defyne and Restylane Lyft Lidocaine | Other | Participants will receive Restylane Shaype in the chin area and Restylane Defyne in the marionette line areas laterally to the chin. Participants in this group will be treated with Restylane Lyft lidocaine in the midface, nasolabial folds (NLF) and /or jawline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane Shaype | Device | Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Rated "Improved" or "Much Improved" or "Very Much Improved" as Assessed by Investigator Using the Global Aesthetic Improvement Scale (GAIS) at Week 8 | At week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Rated "Improved" or "Much Improved" or "Very Much Improved" as Assessed by Investigator Using the GAIS at Week 4 | At week 4 | |
| Percentage of Participants Rated "Improved" or "Much Improved" or "Very Much Improved" as Assessed by the Participant Using the GAIS at week 4 and 8 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Investigational Site # 8754 | Vancouver | British Columbia | V6H 4E1 | Canada | ||
| Galderma Investigational Site 8379 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Restylane Defyne | Device | Injection |
|
| Restylane Lyft lidocaine | Device | Injection |
|
| At weeks 4 and 8 |
| Percentage of Participants Reporting "Agree" or "Strongly Agree", "Satisfied" or "Very satisfied" as per Participant Satisfaction Questionnaire at Week 8 | At week 8 |
| Percentage of Participants in Each Response Category for Every Question in the Participant Satisfaction Questionnaire at Week 8 | At week 8 |
| Percentage of Investigators Reporting "Agree" or "Strongly agree" as per Investigator Satisfaction Questionnaire at Week 8 | At week 8 |
| Percentage of Participants in Each Response Category for Every Question in the Investigator Satisfaction Questionnaire at Week 8 | At week 8 |
| Burlington |
| Ontario |
| L7N3N2 |
| Canada |
| Galderma Investigational Site 8690 | Westmount | Quebec | H3Z 1C3 | Canada |