Trial Outcomes & Findings for Effectiveness and Safety of Restylane Lyft Lidocaine for Jawline Definition (NCT NCT05622812)
NCT ID: NCT05622812
Last Updated: 2025-03-07
Results Overview
The GJS is a validated 5-point scale (ranges 0-4) for assessment of the jawline. Each score in the GJS is represented by photographic images of the scale, where 0 = none to minimal, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe volume deficiency posterior to the jowl along the jawline. The Blinded Evaluator performed live assessment of the participant's left and right jawline separately. Here, a higher score indicated more volume deficiency in the treatment area. A responder was defined as participants having at least a 1-grade improvement from baseline on both jawlines concurrently.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
140 participants
Primary outcome timeframe
Baseline, Month 3
Results posted on
2025-03-07
Participant Flow
The study was conducted at 9 sites in Canada from 16 February 2023 to 14 June 2024.
A total of 150 participants were screened, of which 10 were screen failures. A total of 140 participants were enrolled and randomized in the study.
Participant milestones
| Measure |
Restylane Lyft Lidocaine
Participants received Restylane Lyft Lidocaine injection at Day 1 and one optional touch-up treatment at 1 month after treatment.
|
No-treatment Control Group
Participants remained untreated and were offered optional treatment at 12 months from Baseline (Day 1).
|
|---|---|---|
|
Overall Study
STARTED
|
105
|
35
|
|
Overall Study
COMPLETED
|
102
|
30
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
Restylane Lyft Lidocaine
Participants received Restylane Lyft Lidocaine injection at Day 1 and one optional touch-up treatment at 1 month after treatment.
|
No-treatment Control Group
Participants remained untreated and were offered optional treatment at 12 months from Baseline (Day 1).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
Baseline Characteristics
Effectiveness and Safety of Restylane Lyft Lidocaine for Jawline Definition
Baseline characteristics by cohort
| Measure |
Restylane Lyft Lidocaine
n=105 Participants
Participants received Restylane Lyft Lidocaine injection at Day 1 and one optional touch-up treatment at 1 month after treatment.
|
No-treatment Control Group
n=35 Participants
Participants remained untreated and were offered optional treatment at 12 months from Baseline (Day 1).
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.2 years
STANDARD_DEVIATION 10.82 • n=5 Participants
|
53.2 years
STANDARD_DEVIATION 11.13 • n=7 Participants
|
54.7 years
STANDARD_DEVIATION 10.89 • n=5 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
103 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
94 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 3Population: Analysis was performed on ITT population. The ITT population included all participants who were randomized.
The GJS is a validated 5-point scale (ranges 0-4) for assessment of the jawline. Each score in the GJS is represented by photographic images of the scale, where 0 = none to minimal, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe volume deficiency posterior to the jowl along the jawline. The Blinded Evaluator performed live assessment of the participant's left and right jawline separately. Here, a higher score indicated more volume deficiency in the treatment area. A responder was defined as participants having at least a 1-grade improvement from baseline on both jawlines concurrently.
Outcome measures
| Measure |
Restylane Lyft Lidocaine
n=105 Participants
Participants received Restylane Lyft Lidocaine injection at Day 1 and one optional touch-up treatment at 1 month after treatment.
|
No-treatment Control Group
n=35 Participants
Participants remained untreated and were offered optional treatment at 12 months from Baseline (Day 1).
|
|---|---|---|
|
Percentage of Responders Having At Least a 1-Grade Improvement From Baseline on Both Jawlines Concurrently Based on Galderma Jawline Scale (GJS) at Month 3 as Assessed by Blinded Evaluator
|
67.6 percentage of responders
Interval 57.8 to 76.4
|
28.6 percentage of responders
Interval 14.6 to 46.3
|
SECONDARY outcome
Timeframe: Baseline, Months 6, 9 and 12Population: Analysis was performed on ITT population. The ITT population included all participants who were randomized. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified timepoint.
The GJS is a validated 5-point scale for assessment of the jawline. Each score in the GJS is represented by photographic images of the scale, where 0 = none to minimal, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe volume deficiency posterior to the jowl along the jawline. Here, higher score indicated more volume deficiency in the treatment area. A responder was defined as participants having at least a 1-grade improvement from baseline on both jawlines concurrently.
Outcome measures
| Measure |
Restylane Lyft Lidocaine
n=102 Participants
Participants received Restylane Lyft Lidocaine injection at Day 1 and one optional touch-up treatment at 1 month after treatment.
|
No-treatment Control Group
n=32 Participants
Participants remained untreated and were offered optional treatment at 12 months from Baseline (Day 1).
|
|---|---|---|
|
Percentage of Responders Having at Least a 1-Grade Improvement From Baseline on Both Jawlines Concurrently Based on GJS at Month 6, 9 and 12 as Assessed by Blinded Evaluator
Month 6
|
62.2 percentage of responders
Interval 51.9 to 71.8
|
21.9 percentage of responders
Interval 9.3 to 40.0
|
|
Percentage of Responders Having at Least a 1-Grade Improvement From Baseline on Both Jawlines Concurrently Based on GJS at Month 6, 9 and 12 as Assessed by Blinded Evaluator
Month 9
|
57.8 percentage of responders
Interval 47.7 to 67.6
|
16.1 percentage of responders
Interval 5.5 to 33.7
|
|
Percentage of Responders Having at Least a 1-Grade Improvement From Baseline on Both Jawlines Concurrently Based on GJS at Month 6, 9 and 12 as Assessed by Blinded Evaluator
Month 12
|
49.5 percentage of responders
Interval 39.4 to 59.6
|
19.4 percentage of responders
Interval 7.5 to 37.5
|
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 9 and 12Population: Analysis was performed on the ITT population. The ITT population included all randomized participants. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified timepoint.
The 7-graded GAIS was used to live assess the aesthetic improvement of the jawline, that is, an improvement from baseline appearance before the first treatment by the Treating Investigator and the Participant, independently of each other. The participant responded to the question: "How would you describe the aesthetic improvement of the treatment area today compared to the photograph taken before treatment?" by using the categorical scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse and Very Much Worse. Percentage of participants having at least "Improved" on the GAIS as assessed live by the Treating Investigator was reported here.
Outcome measures
| Measure |
Restylane Lyft Lidocaine
n=102 Participants
Participants received Restylane Lyft Lidocaine injection at Day 1 and one optional touch-up treatment at 1 month after treatment.
|
No-treatment Control Group
n=33 Participants
Participants remained untreated and were offered optional treatment at 12 months from Baseline (Day 1).
|
|---|---|---|
|
Percentage of Participants Having at Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) on Both Jawlines Concurrently, as Assessed Live by the Treating Investigator at Months 3, 6, 9 and 12
Month 3
|
99.0 percentage of participants
Interval 94.7 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 10.6
|
|
Percentage of Participants Having at Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) on Both Jawlines Concurrently, as Assessed Live by the Treating Investigator at Months 3, 6, 9 and 12
Month 6
|
97.0 percentage of participants
Interval 91.4 to 99.4
|
9.4 percentage of participants
Interval 2.0 to 25.0
|
|
Percentage of Participants Having at Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) on Both Jawlines Concurrently, as Assessed Live by the Treating Investigator at Months 3, 6, 9 and 12
Month 9
|
90.2 percentage of participants
Interval 82.7 to 95.2
|
9.7 percentage of participants
Interval 2.0 to 25.8
|
|
Percentage of Participants Having at Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) on Both Jawlines Concurrently, as Assessed Live by the Treating Investigator at Months 3, 6, 9 and 12
Month 12
|
80.4 percentage of participants
Interval 71.4 to 87.6
|
6.7 percentage of participants
Interval 0.8 to 22.1
|
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 9 and 12Population: Analysis was performed on the ITT population. The ITT population included all randomized participants. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified timepoint.
The 7-graded GAIS was used to live assess the aesthetic improvement of the jawline, that is, an improvement from baseline appearance before the first treatment by the Treating Investigator and the Participant, independently of each other. The participant responded to the question: "How would you describe the aesthetic improvement of the treatment area today compared to the photograph taken before treatment?" by using the categorical scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse and Very Much Worse. Percentage of participants having at least "Improved" on the GAIS as assessed live by the participant was reported here.
Outcome measures
| Measure |
Restylane Lyft Lidocaine
n=102 Participants
Participants received Restylane Lyft Lidocaine injection at Day 1 and one optional touch-up treatment at 1 month after treatment.
|
No-treatment Control Group
n=33 Participants
Participants remained untreated and were offered optional treatment at 12 months from Baseline (Day 1).
|
|---|---|---|
|
Percentage of Participants Having at Least "Improved" on the GAIS on Both Jawlines Concurrently, as Assessed Live by the Participant at Months 3, 6, 9 and 12
Month 3
|
93.1 percentage of participants
Interval 86.4 to 97.2
|
0.0 percentage of participants
Interval 0.0 to 10.6
|
|
Percentage of Participants Having at Least "Improved" on the GAIS on Both Jawlines Concurrently, as Assessed Live by the Participant at Months 3, 6, 9 and 12
Month 6
|
87.9 percentage of participants
Interval 79.8 to 93.6
|
0.0 percentage of participants
Interval 0.0 to 10.9
|
|
Percentage of Participants Having at Least "Improved" on the GAIS on Both Jawlines Concurrently, as Assessed Live by the Participant at Months 3, 6, 9 and 12
Month 9
|
80.4 percentage of participants
Interval 71.4 to 87.6
|
0.0 percentage of participants
Interval 0.0 to 11.2
|
|
Percentage of Participants Having at Least "Improved" on the GAIS on Both Jawlines Concurrently, as Assessed Live by the Participant at Months 3, 6, 9 and 12
Month 12
|
71.6 percentage of participants
Interval 61.8 to 80.1
|
0.0 percentage of participants
Interval 0.0 to 11.2
|
Adverse Events
Restylane Lyft Lidocaine
Serious events: 2 serious events
Other events: 39 other events
Deaths: 0 deaths
No-treatment Control Group
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Restylane Lyft Lidocaine
n=105 participants at risk
Participants received Restylane Lyft Lidocaine injection at Day 1 and one optional touch-up treatment at 1 month after treatment.
|
No-treatment Control Group
n=35 participants at risk
Participants remained untreated and were offered optional treatment at 12 months from Baseline (Day 1).
|
|---|---|---|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Infections and infestations
Appendicitis
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
2.9%
1/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
Other adverse events
| Measure |
Restylane Lyft Lidocaine
n=105 participants at risk
Participants received Restylane Lyft Lidocaine injection at Day 1 and one optional touch-up treatment at 1 month after treatment.
|
No-treatment Control Group
n=35 participants at risk
Participants remained untreated and were offered optional treatment at 12 months from Baseline (Day 1).
|
|---|---|---|
|
General disorders
Injection site nodule
|
4.8%
5/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
General disorders
Injection site discomfort
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
General disorders
Injection site pain
|
1.9%
2/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
General disorders
Injection site swelling
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
General disorders
Injection site cyst
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
General disorders
Injection site inflammation
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
General disorders
Injection site mass
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
General disorders
Injection site papule
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Nervous system disorders
Presyncope
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
1.9%
2/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Gastrointestinal disorders
Food poisoning
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Infections and infestations
COVID-19
|
4.8%
5/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
5.7%
2/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Infections and infestations
Nasopharyngitis
|
4.8%
5/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
8.6%
3/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Infections and infestations
Influenza
|
1.9%
2/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
2.9%
1/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Infections and infestations
Urinary tract infection
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Infections and infestations
Appendicitis
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Infections and infestations
Bronchitis
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
2.9%
1/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Infections and infestations
Gastroenteritis viral
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Infections and infestations
Labyrinthitis
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Infections and infestations
Laryngitis
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Infections and infestations
Tooth infection
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
2.9%
1/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
1.9%
2/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
1.9%
2/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
2.9%
1/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
2.9%
1/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
2.9%
1/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Investigations
Blood bilirubin increased
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Nervous system disorders
Headache
|
2.9%
3/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Nervous system disorders
Migraine
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
2.9%
1/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Product Issues
Device breakage
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Reproductive system and breast disorders
Urogenital prolapse
|
0.00%
0/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
2.9%
1/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
2.9%
1/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
2.9%
1/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Skin and subcutaneous tissue disorders
Actinic cheilitis
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
2.9%
1/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
|
Social circumstances
Postmenopause
|
0.95%
1/105 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
0.00%
0/35 • From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place