Trial Outcomes & Findings for Safety and Effectiveness of Restylane® Kysse for Lip Augmentation in Chinese Subjects (NCT NCT05342753)
NCT ID: NCT05342753
Last Updated: 2025-12-22
Results Overview
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Percentage of participants with at least 1-point improvement from baseline on MLFS are reported for this outcome measure.
COMPLETED
NA
22 participants
At Week 8
2025-12-22
Participant Flow
This study was conducted from 13 June 2022 to 07 November 2024.
A total of 25 participants with a score of 1 (Very Thin) or 2 (Thin) on the Medicis Lip Fullness Scale (MLFS) were screened for the study, of which 3 were screen failures. 22 participants were treated with Restylane Kysse in at least 1 lip.
Participant milestones
| Measure |
Restylane Kysse
Participants received an injection in the lips with sufficient amount of Restylane Kysse to achieve optimal aesthetic improvement, as determined by the Investigator and participant at baseline (Day 1) with optional touch-up treatments at the 4-week follow-up visit.
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Restylane Kysse
Participants received an injection in the lips with sufficient amount of Restylane Kysse to achieve optimal aesthetic improvement, as determined by the Investigator and participant at baseline (Day 1) with optional touch-up treatments at the 4-week follow-up visit.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Safety and Effectiveness of Restylane® Kysse for Lip Augmentation in Chinese Subjects
Baseline characteristics by cohort
| Measure |
Restylane Kysse
n=22 Participants
Participants received an injection in the lips with sufficient amount of Restylane Kysse to achieve optimal aesthetic improvement, as determined by the Investigator and participant at baseline (Day 1) with optional touch-up treatments at the 4-week follow-up visit.
|
|---|---|
|
Age, Continuous
|
43.1 years
STANDARD_DEVIATION 13.5 • n=18 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
22 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Han Chinese
|
22 Participants
n=18 Participants
|
|
MLFS-upper lip
1 (very thin)
|
0 Participants
n=18 Participants
|
|
MLFS-upper lip
2 (thin)
|
22 Participants
n=18 Participants
|
|
MLFS-lower lip
1 (very thin)
|
0 Participants
n=18 Participants
|
|
MLFS-lower lip
2 (thin)
|
22 Participants
n=18 Participants
|
PRIMARY outcome
Timeframe: At Week 8Population: The modified intent-to-treat (mITT) population included all participants who were treated in both lips. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure.
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Percentage of participants with at least 1-point improvement from baseline on MLFS are reported for this outcome measure.
Outcome measures
| Measure |
Restylane Kysse
n=19 Participants
Participants received an injection in the lips with sufficient amount of Restylane Kysse to achieve optimal aesthetic improvement, as determined by the Investigator and participant at baseline (Day 1) with optional touch-up treatments at the 4-week follow-up visit.
|
|---|---|
|
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on Medicis Lip Fullness Scale (MLFS)
Lower lip
|
94.7 percentage of participants
|
|
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on Medicis Lip Fullness Scale (MLFS)
Upper lip
|
94.7 percentage of participants
|
PRIMARY outcome
Timeframe: At Week 16Population: The mITT population included all participants who were treated in both lips. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure.
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Percentage of participants with at least 1-point improvement from baseline on MLFS are reported for this outcome measure.
Outcome measures
| Measure |
Restylane Kysse
n=17 Participants
Participants received an injection in the lips with sufficient amount of Restylane Kysse to achieve optimal aesthetic improvement, as determined by the Investigator and participant at baseline (Day 1) with optional touch-up treatments at the 4-week follow-up visit.
|
|---|---|
|
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS
Upper lip
|
94.1 percentage of participants
|
|
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS
Lower lip
|
94.1 percentage of participants
|
PRIMARY outcome
Timeframe: At Week 24Population: The mITT population included all participants who were treated in both lips. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure.
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Percentage of participants with at least 1-point improvement from baseline on MLFS are reported for this outcome measure.
Outcome measures
| Measure |
Restylane Kysse
n=14 Participants
Participants received an injection in the lips with sufficient amount of Restylane Kysse to achieve optimal aesthetic improvement, as determined by the Investigator and participant at baseline (Day 1) with optional touch-up treatments at the 4-week follow-up visit.
|
|---|---|
|
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS
Upper lip
|
92.9 percentage of participants
|
|
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS
Lower lip
|
92.9 percentage of participants
|
PRIMARY outcome
Timeframe: At Week 32Population: The mITT population included all participants who were treated in both lips. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure.
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Percentage of participants with at least 1-point improvement from baseline on MLFS are reported for this outcome measure.
Outcome measures
| Measure |
Restylane Kysse
n=16 Participants
Participants received an injection in the lips with sufficient amount of Restylane Kysse to achieve optimal aesthetic improvement, as determined by the Investigator and participant at baseline (Day 1) with optional touch-up treatments at the 4-week follow-up visit.
|
|---|---|
|
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS
Upper lip
|
87.5 percentage of participants
|
|
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS
Lower lip
|
87.5 percentage of participants
|
PRIMARY outcome
Timeframe: At Week 40Population: The mITT population included all participants who were treated in both lips. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure.
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Percentage of participants with at least 1-point improvement from baseline on MLFS are reported for this outcome measure.
Outcome measures
| Measure |
Restylane Kysse
n=15 Participants
Participants received an injection in the lips with sufficient amount of Restylane Kysse to achieve optimal aesthetic improvement, as determined by the Investigator and participant at baseline (Day 1) with optional touch-up treatments at the 4-week follow-up visit.
|
|---|---|
|
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS
Upper lip
|
86.7 percentage of participants
|
|
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS
Lower lip
|
86.7 percentage of participants
|
PRIMARY outcome
Timeframe: At Week 48Population: The mITT population included all participants who were treated in both lips. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure.
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Percentage of participants with at least 1-point improvement from baseline on MLFS are reported for this outcome measure.
Outcome measures
| Measure |
Restylane Kysse
n=15 Participants
Participants received an injection in the lips with sufficient amount of Restylane Kysse to achieve optimal aesthetic improvement, as determined by the Investigator and participant at baseline (Day 1) with optional touch-up treatments at the 4-week follow-up visit.
|
|---|---|
|
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS
Upper lip
|
86.7 percentage of participants
|
|
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS
Lower lip
|
86.7 percentage of participants
|
PRIMARY outcome
Timeframe: 8 weeks after last injection (up to 12 weeks)Population: The mITT population included all participants who were treated in both lips. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure.
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Improvement was defined as at least 1-point change from baseline in lip fullness. Number of participants with no improvement, one grade, two grade and three grade improvement are reported for this outcome measure.
Outcome measures
| Measure |
Restylane Kysse
n=19 Participants
Participants received an injection in the lips with sufficient amount of Restylane Kysse to achieve optimal aesthetic improvement, as determined by the Investigator and participant at baseline (Day 1) with optional touch-up treatments at the 4-week follow-up visit.
|
|---|---|
|
Change From Baseline on the MLFS by Treatment Area at Week 8 After the Last Injection
Upper lip · No improvement
|
1 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 8 After the Last Injection
Upper lip · One grade improvement
|
10 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 8 After the Last Injection
Upper lip · Two grade improvement
|
7 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 8 After the Last Injection
Upper lip · Three grade improvement
|
1 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 8 After the Last Injection
Lower lip · No improvement
|
1 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 8 After the Last Injection
Lower lip · One grade improvement
|
8 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 8 After the Last Injection
Lower lip · Two grade improvement
|
9 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 8 After the Last Injection
Lower lip · Three grade improvement
|
1 Participants
|
PRIMARY outcome
Timeframe: 16 weeks after last injection (up to 20 weeks)Population: The mITT population included all participants who were treated in both lips. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure.
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Improvement was defined as at least 1-point change from baseline in lip fullness. Number of participants with no improvement, one grade, two grade and three grade improvement are reported for this outcome measure.
Outcome measures
| Measure |
Restylane Kysse
n=17 Participants
Participants received an injection in the lips with sufficient amount of Restylane Kysse to achieve optimal aesthetic improvement, as determined by the Investigator and participant at baseline (Day 1) with optional touch-up treatments at the 4-week follow-up visit.
|
|---|---|
|
Change From Baseline on the MLFS by Treatment Area at Week 16 After the Last Injection
Upper lip · No improvement
|
1 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 16 After the Last Injection
Upper lip · One grade improvement
|
7 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 16 After the Last Injection
Upper lip · Two grade improvement
|
8 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 16 After the Last Injection
Upper lip · Three grade improvement
|
1 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 16 After the Last Injection
Lower lip · No improvement
|
1 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 16 After the Last Injection
Lower lip · One grade improvement
|
6 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 16 After the Last Injection
Lower lip · Two grade improvement
|
9 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 16 After the Last Injection
Lower lip · Three grade improvement
|
1 Participants
|
PRIMARY outcome
Timeframe: 24 weeks after last injection (up to 28 weeks)Population: The mITT population included all participants who were treated in both lips. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure.
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Improvement was defined as at least 1-point change from baseline in lip fullness. Number of participants with no improvement, one grade, two grade and three grade improvement are reported for this outcome measure.
Outcome measures
| Measure |
Restylane Kysse
n=14 Participants
Participants received an injection in the lips with sufficient amount of Restylane Kysse to achieve optimal aesthetic improvement, as determined by the Investigator and participant at baseline (Day 1) with optional touch-up treatments at the 4-week follow-up visit.
|
|---|---|
|
Change From Baseline on the MLFS by Treatment Area at Week 24 After the Last Injection
Upper lip · No improvement
|
1 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 24 After the Last Injection
Upper lip · One grade improvement
|
6 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 24 After the Last Injection
Upper lip · Two grade improvement
|
6 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 24 After the Last Injection
Upper lip · Three grade improvement
|
1 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 24 After the Last Injection
Lower lip · No improvement
|
1 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 24 After the Last Injection
Lower lip · One grade improvement
|
6 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 24 After the Last Injection
Lower lip · Two grade improvement
|
6 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 24 After the Last Injection
Lower lip · Three grade improvement
|
1 Participants
|
PRIMARY outcome
Timeframe: 32 weeks after last injection (up to 36 weeks)Population: The mITT population included all participants who were treated in both lips. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure.
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Improvement was defined as at least 1-point change from baseline in lip fullness. Number of participants with no improvement, one grade, two grade and three grade improvement are reported for this outcome measure.
Outcome measures
| Measure |
Restylane Kysse
n=16 Participants
Participants received an injection in the lips with sufficient amount of Restylane Kysse to achieve optimal aesthetic improvement, as determined by the Investigator and participant at baseline (Day 1) with optional touch-up treatments at the 4-week follow-up visit.
|
|---|---|
|
Change From Baseline on the MLFS by Treatment Area at Week 32 After the Last Injection
Upper lip · No improvement
|
2 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 32 After the Last Injection
Upper lip · One grade improvement
|
9 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 32 After the Last Injection
Upper lip · Two grade improvement
|
4 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 32 After the Last Injection
Upper lip · Three grade improvement
|
1 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 32 After the Last Injection
Lower lip · No improvement
|
2 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 32 After the Last Injection
Lower lip · One grade improvement
|
8 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 32 After the Last Injection
Lower lip · Two grade improvement
|
5 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 32 After the Last Injection
Lower lip · Three grade improvement
|
1 Participants
|
PRIMARY outcome
Timeframe: 40 weeks after last injection (up to 44 weeks)Population: The mITT population included all participants who were treated in both lips. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure.
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Improvement was defined as at least 1-point change from baseline in lip fullness. Number of participants with no improvement, one grade, two grade and three grade improvement are reported for this outcome measure.
Outcome measures
| Measure |
Restylane Kysse
n=15 Participants
Participants received an injection in the lips with sufficient amount of Restylane Kysse to achieve optimal aesthetic improvement, as determined by the Investigator and participant at baseline (Day 1) with optional touch-up treatments at the 4-week follow-up visit.
|
|---|---|
|
Change From Baseline on the MLFS by Treatment Area at Week 40 After the Last Injection
Upper lip · No improvement
|
2 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 40 After the Last Injection
Upper lip · One grade improvement
|
8 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 40 After the Last Injection
Upper lip · Two grade improvement
|
4 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 40 After the Last Injection
Upper lip · Three grade improvement
|
1 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 40 After the Last Injection
Lower lip · No improvement
|
2 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 40 After the Last Injection
Lower lip · One grade improvement
|
7 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 40 After the Last Injection
Lower lip · Two grade improvement
|
5 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 40 After the Last Injection
Lower lip · Three grade improvement
|
1 Participants
|
PRIMARY outcome
Timeframe: 48 weeks after last injection (up to 52 weeks)Population: The mITT population included all participants who were treated in both lips. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure.
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Improvement was defined as at least 1-point change from baseline in lip fullness. Number of participants with no improvement, one grade, two grade and three grade improvement are reported for this outcome measure.
Outcome measures
| Measure |
Restylane Kysse
n=15 Participants
Participants received an injection in the lips with sufficient amount of Restylane Kysse to achieve optimal aesthetic improvement, as determined by the Investigator and participant at baseline (Day 1) with optional touch-up treatments at the 4-week follow-up visit.
|
|---|---|
|
Change From Baseline on the MLFS by Treatment Area at Week 48 After the Last Injection
Upper lip · No improvement
|
2 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 48 After the Last Injection
Upper lip · One grade improvement
|
9 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 48 After the Last Injection
Upper lip · Two grade improvement
|
4 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 48 After the Last Injection
Upper lip · Three grade improvement
|
0 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 48 After the Last Injection
Lower lip · No improvement
|
2 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 48 After the Last Injection
Lower lip · One grade improvement
|
9 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 48 After the Last Injection
Lower lip · Two grade improvement
|
4 Participants
|
|
Change From Baseline on the MLFS by Treatment Area at Week 48 After the Last Injection
Lower lip · Three grade improvement
|
0 Participants
|
SECONDARY outcome
Timeframe: At Weeks 8, 16, 24, 32, 40, and 48Population: The mITT population included all participants who were treated in both lips. Here, 'number analyzed' signifies participants evaluable for this outcome measure.
The WAS is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds. Scoring of fold severity is based on visual assessment of the length and apparent depth of the wrinkle at a certain time-point. Scoring of the upper perioral rhytids and oral commissures was based on visual live assessment by the investigator at defined time points; by using respective categorical scale ranging from Grade 0 to 5 where: grade 0 or 'No wrinkles', (1) 'Just perceptible wrinkle', (2) 'Shallow wrinkles', (3) 'Moderately deep wrinkle', (4) 'Deep wrinkle, well-defined edges', (5) 'Very deep wrinkle, redundant fold', higher grade represented higher fold severity. Responder was defined as a participant with at least a 1-point improvement from baseline.
Outcome measures
| Measure |
Restylane Kysse
n=22 Participants
Participants received an injection in the lips with sufficient amount of Restylane Kysse to achieve optimal aesthetic improvement, as determined by the Investigator and participant at baseline (Day 1) with optional touch-up treatments at the 4-week follow-up visit.
|
|---|---|
|
Percentage of Responders With At Least "Improved" on the Wrinkle Assessment Scale (WAS)
Upper perioral rhytids; Week 8
|
100 percentage of participants
Interval 15.8 to 100.0
|
|
Percentage of Responders With At Least "Improved" on the Wrinkle Assessment Scale (WAS)
Upper perioral rhytids; Week 16
|
100 percentage of participants
Interval 2.5 to 100.0
|
|
Percentage of Responders With At Least "Improved" on the Wrinkle Assessment Scale (WAS)
Upper perioral rhytids; Week 24
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
|
Percentage of Responders With At Least "Improved" on the Wrinkle Assessment Scale (WAS)
Upper perioral rhytids; Week 32
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
|
Percentage of Responders With At Least "Improved" on the Wrinkle Assessment Scale (WAS)
Upper perioral rhytids; Week 40
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
|
Percentage of Responders With At Least "Improved" on the Wrinkle Assessment Scale (WAS)
Upper perioral rhytids; Week 48
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
|
Percentage of Responders With At Least "Improved" on the Wrinkle Assessment Scale (WAS)
Left oral commissures; Week 8
|
92.3 percentage of participants
Interval 64.0 to 99.8
|
|
Percentage of Responders With At Least "Improved" on the Wrinkle Assessment Scale (WAS)
Left oral commissures; Week 16
|
100.0 percentage of participants
Interval 73.5 to 100.0
|
|
Percentage of Responders With At Least "Improved" on the Wrinkle Assessment Scale (WAS)
Left oral commissures; Week 24
|
90.9 percentage of participants
Interval 58.7 to 99.8
|
|
Percentage of Responders With At Least "Improved" on the Wrinkle Assessment Scale (WAS)
Left oral commissures; Week 32
|
91.7 percentage of participants
Interval 61.5 to 99.8
|
|
Percentage of Responders With At Least "Improved" on the Wrinkle Assessment Scale (WAS)
Left oral commissures; Week 40
|
100.0 percentage of participants
Interval 71.5 to 100.0
|
|
Percentage of Responders With At Least "Improved" on the Wrinkle Assessment Scale (WAS)
Left oral commissures; Week 48
|
100.0 percentage of participants
Interval 71.5 to 100.0
|
|
Percentage of Responders With At Least "Improved" on the Wrinkle Assessment Scale (WAS)
Right oral commissures; Week 8
|
92.3 percentage of participants
Interval 64.0 to 99.8
|
|
Percentage of Responders With At Least "Improved" on the Wrinkle Assessment Scale (WAS)
Right oral commissures; Week 16
|
100.0 percentage of participants
Interval 73.5 to 100.0
|
|
Percentage of Responders With At Least "Improved" on the Wrinkle Assessment Scale (WAS)
Right oral commissures; Week 24
|
90.9 percentage of participants
Interval 58.7 to 99.8
|
|
Percentage of Responders With At Least "Improved" on the Wrinkle Assessment Scale (WAS)
Right oral commissures; Week 32
|
91.7 percentage of participants
Interval 61.5 to 99.8
|
|
Percentage of Responders With At Least "Improved" on the Wrinkle Assessment Scale (WAS)
Right oral commissures; Week 40
|
100.0 percentage of participants
Interval 71.5 to 100.0
|
|
Percentage of Responders With At Least "Improved" on the Wrinkle Assessment Scale (WAS)
Right oral commissures; Week 48
|
100.0 percentage of participants
Interval 71.5 to 100.0
|
SECONDARY outcome
Timeframe: At Weeks 8, 16, 24, 32, 40, and 48Population: The mITT population included all participants who were treated in both lips. Here, 'number analyzed' signifies participants evaluable for this outcome measure.
The GAIS is a 7-point categorical scale ranging from -3 (Very Much Worse) to +3 (very much improved), used by the Treating Investigator to assess changes in the appearance of participants' lips following treatment by responding to the question: "With respect to the appearance of the participant's lips, how would you describe the result of the lip treatment compared to the photos taken before treatment?" by using the respective categorical scale as follows: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse. In this outcome measure, percentage of participants who achieved at least 'Improved' on the GAIS assessed by treating investigator at Weeks 8, 16, 24, 32, 40, and 48 were reported.
Outcome measures
| Measure |
Restylane Kysse
n=22 Participants
Participants received an injection in the lips with sufficient amount of Restylane Kysse to achieve optimal aesthetic improvement, as determined by the Investigator and participant at baseline (Day 1) with optional touch-up treatments at the 4-week follow-up visit.
|
|---|---|
|
Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Treating Investigator at Weeks 8, 16, 24, 32, 40, and 48
At Week 8
|
100.0 percentage of participants
Interval 82.4 to 100.0
|
|
Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Treating Investigator at Weeks 8, 16, 24, 32, 40, and 48
At Week 16
|
100.0 percentage of participants
Interval 80.5 to 100.0
|
|
Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Treating Investigator at Weeks 8, 16, 24, 32, 40, and 48
At Week 24
|
100.0 percentage of participants
Interval 76.8 to 100.0
|
|
Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Treating Investigator at Weeks 8, 16, 24, 32, 40, and 48
At Week 32
|
100.0 percentage of participants
Interval 79.4 to 100.0
|
|
Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Treating Investigator at Weeks 8, 16, 24, 32, 40, and 48
At Week 40
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
|
Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Treating Investigator at Weeks 8, 16, 24, 32, 40, and 48
At Week 48
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
Adverse Events
Restylane Kysse
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Restylane Kysse
n=22 participants at risk
Participants received an injection in the lips with sufficient amount of Restylane Kysse to achieve optimal aesthetic improvement, as determined by the Investigator and participant at baseline (Day 1) with optional touch-up treatments at the 4-week follow-up visit.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
4.5%
1/22 • From Visit 1 of the study up to follow-up visit (Week 48)
The safety population included all subjects who were treated with Restylane Kysse in at least 1 lip and were analyzed according to the treatment actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.5%
1/22 • From Visit 1 of the study up to follow-up visit (Week 48)
The safety population included all subjects who were treated with Restylane Kysse in at least 1 lip and were analyzed according to the treatment actually received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place