Trial Outcomes & Findings for Safety and Effectiveness of Restylane Lyft With Lidocaine for Augmentation of the Chin Region to Improve the Chin Profile (NCT NCT05777759)
NCT ID: NCT05777759
Last Updated: 2026-05-28
Results Overview
GCRS is a validated 4-grade scale to assess the chin retrusion from no retrusion (0) to severe retrusion (3) which was described as follows; "0- No retrusion", "1- Mild retrusion", "2- Moderate retrusion", "3- Severe retrusion". Higher scores indicated more severity. Least squares (LS) mean, and 95 percent (%) confidence interval (CI) were obtained from a general linear mixed random intercept model with treatment group and baseline Galderma Chin Retrusion Scale score as fixed factors.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
175 participants
Primary outcome timeframe
Baseline (last non-missing observation prior to the first administration of study product) and Month 3
Results posted on
2026-05-28
Participant Flow
This study was conducted at 12 investigational sites in the United States of America from 22 March 2023 to 10 July 2024.
A total of 175 participants were randomized (2:1) to treatment with Restylane Lyft with Lidocaine and comparator control.
Participant milestones
| Measure |
Restylane Lyft With Lidocaine
Participants received supraperiosteal or subcutaneous injections of Restylane Lyft with Lidocaine, up to a maximum volume of 4.0 milliliter (mL), administered using needles or cannulas in the chin area on Day 1. An optional touch-up treatment was permitted 1 month after the initial treatment.
|
Active Comparator: Juvederm Voluma XC
Participants received supraperiosteal or subcutaneous injections of Juvederm Voluma XC, up to a maximum volume of 4.0 mL, administered using needles or cannulas in the chin area on Day 1. An optional touch-up treatment was permitted 1 month after the initial treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
115
|
60
|
|
Overall Study
Safety Population
|
115
|
59
|
|
Overall Study
COMPLETED
|
108
|
53
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
Reasons for withdrawal
| Measure |
Restylane Lyft With Lidocaine
Participants received supraperiosteal or subcutaneous injections of Restylane Lyft with Lidocaine, up to a maximum volume of 4.0 milliliter (mL), administered using needles or cannulas in the chin area on Day 1. An optional touch-up treatment was permitted 1 month after the initial treatment.
|
Active Comparator: Juvederm Voluma XC
Participants received supraperiosteal or subcutaneous injections of Juvederm Voluma XC, up to a maximum volume of 4.0 mL, administered using needles or cannulas in the chin area on Day 1. An optional touch-up treatment was permitted 1 month after the initial treatment.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Other
|
0
|
1
|
Baseline Characteristics
Safety and Effectiveness of Restylane Lyft With Lidocaine for Augmentation of the Chin Region to Improve the Chin Profile
Baseline characteristics by cohort
| Measure |
Restylane Lyft With Lidocaine
n=115 Participants
Participants received subcutaneous injections of Restylane Lyft with Lidocaine, up to a maximum volume of 4.0 mL, administered using needles or cannulas in the chin area on Day 1. An optional touch-up treatment was permitted 1 month after the initial treatment.
|
Active Comparator: Juvederm Voluma XC
n=60 Participants
Participants received subcutaneous injections of Juvederm Voluma XC in the chin area on Day 1, up to a maximum volume of 4.0 mL, administered using needles or cannulas. An optional touch-up treatment was permitted 1 month after the initial treatment.
|
Total
n=175 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Continuous
|
44.4 years
STANDARD_DEVIATION 12.14 • n=51 Participants
|
47.0 years
STANDARD_DEVIATION 12.97 • n=14 Participants
|
45.3 years
STANDARD_DEVIATION 12.46 • n=65 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=51 Participants
|
52 Participants
n=14 Participants
|
156 Participants
n=65 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=51 Participants
|
8 Participants
n=14 Participants
|
19 Participants
n=65 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
37 Participants
n=51 Participants
|
17 Participants
n=14 Participants
|
54 Participants
n=65 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
78 Participants
n=51 Participants
|
43 Participants
n=14 Participants
|
121 Participants
n=65 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
PRIMARY outcome
Timeframe: Baseline (last non-missing observation prior to the first administration of study product) and Month 3Population: The intention-to-treat (ITT) population included all participants who were randomized and were analyzed according to the randomization scheme.
GCRS is a validated 4-grade scale to assess the chin retrusion from no retrusion (0) to severe retrusion (3) which was described as follows; "0- No retrusion", "1- Mild retrusion", "2- Moderate retrusion", "3- Severe retrusion". Higher scores indicated more severity. Least squares (LS) mean, and 95 percent (%) confidence interval (CI) were obtained from a general linear mixed random intercept model with treatment group and baseline Galderma Chin Retrusion Scale score as fixed factors.
Outcome measures
| Measure |
Restylane Lyft With Lidocaine
n=115 Participants
Participants received subcutaneous injections of Restylane Lyft with Lidocaine, up to a maximum volume of 4.0 mL, administered using needles or cannulas in the chin area on Day 1. An optional touch-up treatment was permitted 1 month after the initial treatment.
|
Active Comparator: Juvederm Voluma XC
n=60 Participants
Participants received subcutaneous injections of Juvederm Voluma XC in the chin area on Day 1, up to a maximum volume of 4.0 mL, administered using needles or cannulas. An optional touch-up treatment was permitted 1 month after the initial treatment.
|
|---|---|---|
|
Change From Baseline in the Blinded Evaluators' Live Assessment Using the Galderma Chin Retrusion Scale (GCRS) at Month 3
|
-0.94 score on a scale
Interval -1.038 to -0.848
|
-1.02 score on a scale
Interval -1.145 to -0.887
|
SECONDARY outcome
Timeframe: At Months 6, 9, and 12Population: ITT population included all participants who were randomized and were analyzed according to the randomization scheme. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "Number Analyzed" signifies participants who were evaluable for specified timepoints.
GCRS is a validated 4-grade scale to assess the chin retrusion from no retrusion (0) to severe retrusion (3) which was described as follows; "0- No retrusion", "1- Mild retrusion", "2- Moderate retrusion", "3- Severe retrusion". Higher scores indicated more severity. Responder rate was defined as percentage of participants with an improvement of at least one grade on the GCRS from baseline. 95% CI was calculated using Clopper-Pearson method.
Outcome measures
| Measure |
Restylane Lyft With Lidocaine
n=110 Participants
Participants received subcutaneous injections of Restylane Lyft with Lidocaine, up to a maximum volume of 4.0 mL, administered using needles or cannulas in the chin area on Day 1. An optional touch-up treatment was permitted 1 month after the initial treatment.
|
Active Comparator: Juvederm Voluma XC
n=55 Participants
Participants received subcutaneous injections of Juvederm Voluma XC in the chin area on Day 1, up to a maximum volume of 4.0 mL, administered using needles or cannulas. An optional touch-up treatment was permitted 1 month after the initial treatment.
|
|---|---|---|
|
Responder Rate Based on the Blinded Evaluator's Live Assessment Using the GCRS at Months 6, 9, and 12
At Month 6
|
75.5 percentage of participants
Interval 66.33 to 83.16
|
80.0 percentage of participants
Interval 67.03 to 89.57
|
|
Responder Rate Based on the Blinded Evaluator's Live Assessment Using the GCRS at Months 6, 9, and 12
At Month 9
|
69.1 percentage of participants
Interval 59.57 to 77.55
|
79.2 percentage of participants
Interval 65.89 to 89.16
|
|
Responder Rate Based on the Blinded Evaluator's Live Assessment Using the GCRS at Months 6, 9, and 12
At Month 12
|
69.7 percentage of participants
Interval 60.19 to 78.16
|
77.8 percentage of participants
Interval 64.4 to 87.96
|
Adverse Events
Restylane Lyft With Lidocaine
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Active Comparator: Juvederm Voluma XC
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Restylane Lyft With Lidocaine
n=115 participants at risk
Participants received subcutaneous injections of Restylane Lyft with Lidocaine, up to a maximum volume of 4.0 mL, administered using needles or cannulas in the chin area on Day 1. An optional touch-up treatment was permitted 1 month after the initial treatment.
|
Active Comparator: Juvederm Voluma XC
n=59 participants at risk
Participants received subcutaneous injections of Juvederm Voluma XC in the chin area on Day 1, up to a maximum volume of 4.0 mL, administered using needles or cannulas. An optional touch-up treatment was permitted 1 month after the initial treatment.
|
|---|---|---|
|
Cardiac disorders
Atrial flutter
|
0.87%
1/115 • From Baseline up to 12 months
The safety population included all participants who were treated with Restylane Lyft with Lidocaine or comparator control and were analyzed according to the actual treatment received. ITT population was used for all-cause mortality. ITT population included all participants who were randomized and were analyzed according to the randomization scheme.
|
0.00%
0/59 • From Baseline up to 12 months
The safety population included all participants who were treated with Restylane Lyft with Lidocaine or comparator control and were analyzed according to the actual treatment received. ITT population was used for all-cause mortality. ITT population included all participants who were randomized and were analyzed according to the randomization scheme.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.87%
1/115 • From Baseline up to 12 months
The safety population included all participants who were treated with Restylane Lyft with Lidocaine or comparator control and were analyzed according to the actual treatment received. ITT population was used for all-cause mortality. ITT population included all participants who were randomized and were analyzed according to the randomization scheme.
|
0.00%
0/59 • From Baseline up to 12 months
The safety population included all participants who were treated with Restylane Lyft with Lidocaine or comparator control and were analyzed according to the actual treatment received. ITT population was used for all-cause mortality. ITT population included all participants who were randomized and were analyzed according to the randomization scheme.
|
Other adverse events
| Measure |
Restylane Lyft With Lidocaine
n=115 participants at risk
Participants received subcutaneous injections of Restylane Lyft with Lidocaine, up to a maximum volume of 4.0 mL, administered using needles or cannulas in the chin area on Day 1. An optional touch-up treatment was permitted 1 month after the initial treatment.
|
Active Comparator: Juvederm Voluma XC
n=59 participants at risk
Participants received subcutaneous injections of Juvederm Voluma XC in the chin area on Day 1, up to a maximum volume of 4.0 mL, administered using needles or cannulas. An optional touch-up treatment was permitted 1 month after the initial treatment.
|
|---|---|---|
|
Infections and infestations
COVID-19
|
4.3%
5/115 • From Baseline up to 12 months
The safety population included all participants who were treated with Restylane Lyft with Lidocaine or comparator control and were analyzed according to the actual treatment received. ITT population was used for all-cause mortality. ITT population included all participants who were randomized and were analyzed according to the randomization scheme.
|
3.4%
2/59 • From Baseline up to 12 months
The safety population included all participants who were treated with Restylane Lyft with Lidocaine or comparator control and were analyzed according to the actual treatment received. ITT population was used for all-cause mortality. ITT population included all participants who were randomized and were analyzed according to the randomization scheme.
|
|
Infections and infestations
Sinusitis
|
3.5%
4/115 • From Baseline up to 12 months
The safety population included all participants who were treated with Restylane Lyft with Lidocaine or comparator control and were analyzed according to the actual treatment received. ITT population was used for all-cause mortality. ITT population included all participants who were randomized and were analyzed according to the randomization scheme.
|
0.00%
0/59 • From Baseline up to 12 months
The safety population included all participants who were treated with Restylane Lyft with Lidocaine or comparator control and were analyzed according to the actual treatment received. ITT population was used for all-cause mortality. ITT population included all participants who were randomized and were analyzed according to the randomization scheme.
|
|
General disorders
Implant site bruising
|
2.6%
3/115 • From Baseline up to 12 months
The safety population included all participants who were treated with Restylane Lyft with Lidocaine or comparator control and were analyzed according to the actual treatment received. ITT population was used for all-cause mortality. ITT population included all participants who were randomized and were analyzed according to the randomization scheme.
|
0.00%
0/59 • From Baseline up to 12 months
The safety population included all participants who were treated with Restylane Lyft with Lidocaine or comparator control and were analyzed according to the actual treatment received. ITT population was used for all-cause mortality. ITT population included all participants who were randomized and were analyzed according to the randomization scheme.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place