Lip Augmentation
Conditions
Brief summary
Open-label, phase IV, post-marketing study to evaluate aesthetic improvement in Chinese subjects after treatment with Restylane Kysse.
Interventions
DEVICERestylane Kysse
Hyaluronic Acid: Injectable gel for lip augmentation and the correction of upper perioral rhytids
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants willing to comply with the requirements of the study and providing a signed written informed consent * Ability to adequately understand the verbal explanations and the written subject information provided in English * Subjects seeking augmentation therapy for the lips * Adult males or non-pregnant, non-breastfeeding females, 22 years of age or older with both biological parents of full Chinese descent
Exclusion criteria
* Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram-positive bacterial proteins * Previous use of any permanent (non-biodegradable) or semipermanent (e.g., calcium hydroxylapatite or poly-L-lactic acid) facial tissue augmentation therapy, lifting threads, permanent implants or autologous fat below the level of the lower orbital rim. * Previous use of any HA-based or collagen-based biodegradable facial tissue augmentation therapy below the level of the lower orbital rim within 12 months prior to the baseline visit. * Previous facial surgery, within 6 months, below the level of the lower orbital rim * Previous surgery to the upper or lower lip, lip piercing or tattoo, or history of facial trauma. * Participation in any interventional clinical study within 30 days of screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline on the MLFS by Treatment Area at Week 48 After the Last Injection | 48 weeks after last injection (up to 52 weeks) | 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. |
| Change From Baseline on the MLFS by Treatment Area at Week 32 After the Last Injection | 32 weeks after last injection (up to 36 weeks) | 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. |
| Change From Baseline on the MLFS by Treatment Area at Week 40 After the Last Injection | 40 weeks after last injection (up to 44 weeks) | 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. |
| Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on Medicis Lip Fullness Scale (MLFS) | At Week 8 | 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. |
| Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS | At Week 16 | 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. |
| Change From Baseline on the MLFS by Treatment Area at Week 8 After the Last Injection | 8 weeks after last injection (up to 12 weeks) | 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. |
| Change From Baseline on the MLFS by Treatment Area at Week 16 After the Last Injection | 16 weeks after last injection (up to 20 weeks) | 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. |
| Change From Baseline on the MLFS by Treatment Area at Week 24 After the Last Injection | 24 weeks after last injection (up to 28 weeks) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 Weeks 8, 16, 24, 32, 40, and 48 | 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. |
| Percentage of Responders With At Least Improved on the Wrinkle Assessment Scale (WAS) | At Weeks 8, 16, 24, 32, 40, and 48 | 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. |
Countries
United States
Participant flow
Recruitment details
This study was conducted from 13 June 2022 to 07 November 2024.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Restylane Kysse |
|---|---|
| Age, Continuous | 43.1 years STANDARD_DEVIATION 13.5 |
| MLFS-lower lip 1 (very thin) | 0 Participants |
| MLFS-lower lip 2 (thin) | 22 Participants |
| MLFS-upper lip 1 (very thin) | 0 Participants |
| MLFS-upper lip 2 (thin) | 22 Participants |
| Race/Ethnicity, Customized Han Chinese | 22 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 22 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 22 |
| other Total, other adverse events | 2 / 22 |
| serious Total, serious adverse events | 0 / 22 |
Outcome results
Primary
Change From Baseline on the MLFS by Treatment Area at Week 16 After the Last Injection
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.
Time frame: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 16 After the Last Injection | Upper lip | No improvement | 1 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 16 After the Last Injection | Lower lip | One grade improvement | 6 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 16 After the Last Injection | Lower lip | Two grade improvement | 9 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 16 After the Last Injection | Lower lip | Three grade improvement | 1 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 16 After the Last Injection | Upper lip | One grade improvement | 7 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 16 After the Last Injection | Upper lip | Two grade improvement | 8 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 16 After the Last Injection | Upper lip | Three grade improvement | 1 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 16 After the Last Injection | Lower lip | No improvement | 1 Participants |
Primary
Change From Baseline on the MLFS by Treatment Area at Week 24 After the Last Injection
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.
Time frame: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 24 After the Last Injection | Upper lip | No improvement | 1 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 24 After the Last Injection | Upper lip | Three grade improvement | 1 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 24 After the Last Injection | Upper lip | One grade improvement | 6 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 24 After the Last Injection | Upper lip | Two grade improvement | 6 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 24 After the Last Injection | Lower lip | No improvement | 1 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 24 After the Last Injection | Lower lip | One grade improvement | 6 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 24 After the Last Injection | Lower lip | Two grade improvement | 6 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 24 After the Last Injection | Lower lip | Three grade improvement | 1 Participants |
Primary
Change From Baseline on the MLFS by Treatment Area at Week 32 After the Last Injection
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.
Time frame: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 32 After the Last Injection | Upper lip | Three grade improvement | 1 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 32 After the Last Injection | Lower lip | No improvement | 2 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 32 After the Last Injection | Upper lip | No improvement | 2 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 32 After the Last Injection | Upper lip | One grade improvement | 9 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 32 After the Last Injection | Upper lip | Two grade improvement | 4 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 32 After the Last Injection | Lower lip | One grade improvement | 8 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 32 After the Last Injection | Lower lip | Two grade improvement | 5 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 32 After the Last Injection | Lower lip | Three grade improvement | 1 Participants |
Primary
Change From Baseline on the MLFS by Treatment Area at Week 40 After the Last Injection
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.
Time frame: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 40 After the Last Injection | Upper lip | No improvement | 2 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 40 After the Last Injection | Upper lip | One grade improvement | 8 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 40 After the Last Injection | Upper lip | Two grade improvement | 4 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 40 After the Last Injection | Upper lip | Three grade improvement | 1 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 40 After the Last Injection | Lower lip | One grade improvement | 7 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 40 After the Last Injection | Lower lip | No improvement | 2 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 40 After the Last Injection | Lower lip | Two grade improvement | 5 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 40 After the Last Injection | Lower lip | Three grade improvement | 1 Participants |
Primary
Change From Baseline on the MLFS by Treatment Area at Week 48 After the Last Injection
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.
Time frame: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 48 After the Last Injection | Upper lip | No improvement | 2 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 48 After the Last Injection | Upper lip | One grade improvement | 9 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 48 After the Last Injection | Upper lip | Two grade improvement | 4 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 48 After the Last Injection | Upper lip | Three grade improvement | 0 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 48 After the Last Injection | Lower lip | No improvement | 2 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 48 After the Last Injection | Lower lip | One grade improvement | 9 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 48 After the Last Injection | Lower lip | Two grade improvement | 4 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 48 After the Last Injection | Lower lip | Three grade improvement | 0 Participants |
Primary
Change From Baseline on the MLFS by Treatment Area at Week 8 After the Last Injection
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.
Time frame: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 8 After the Last Injection | Upper lip | No improvement | 1 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 8 After the Last Injection | Upper lip | Three grade improvement | 1 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 8 After the Last Injection | Lower lip | One grade improvement | 8 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 8 After the Last Injection | Lower lip | Three grade improvement | 1 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 8 After the Last Injection | Upper lip | One grade improvement | 10 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 8 After the Last Injection | Upper lip | Two grade improvement | 7 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 8 After the Last Injection | Lower lip | No improvement | 1 Participants |
| Restylane Kysse | Change From Baseline on the MLFS by Treatment Area at Week 8 After the Last Injection | Lower lip | Two grade improvement | 9 Participants |
Primary
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on Medicis Lip Fullness Scale (MLFS)
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.
Time frame: At Week 8
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Restylane Kysse | 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 |
| Restylane Kysse | 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 |
Primary
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS
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.
Time frame: At Week 24
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Restylane Kysse | Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS | Upper lip | 92.9 percentage of participants |
| Restylane Kysse | Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS | Lower lip | 92.9 percentage of participants |
Primary
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS
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.
Time frame: At Week 40
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Restylane Kysse | Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS | Lower lip | 86.7 percentage of participants |
| Restylane Kysse | Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS | Upper lip | 86.7 percentage of participants |
Primary
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS
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.
Time frame: At Week 32
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Restylane Kysse | Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS | Upper lip | 87.5 percentage of participants |
| Restylane Kysse | Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS | Lower lip | 87.5 percentage of participants |
Primary
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS
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.
Time frame: At Week 48
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Restylane Kysse | Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS | Upper lip | 86.7 percentage of participants |
| Restylane Kysse | Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS | Lower lip | 86.7 percentage of participants |
Primary
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS
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.
Time frame: At Week 16
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Restylane Kysse | Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS | Upper lip | 94.1 percentage of participants |
| Restylane Kysse | Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS | Lower lip | 94.1 percentage of participants |
Secondary
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
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.
Time frame: At Weeks 8, 16, 24, 32, 40, and 48
Population: The mITT population included all participants who were treated in both lips. Here, 'number analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Restylane Kysse | 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 |
| Restylane Kysse | 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 |
| Restylane Kysse | 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 |
| Restylane Kysse | 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 |
| Restylane Kysse | 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 |
| Restylane Kysse | 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 |
Secondary
Percentage of Responders With At Least Improved on the Wrinkle Assessment Scale (WAS)
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.
Time frame: At Weeks 8, 16, 24, 32, 40, and 48
Population: The mITT population included all participants who were treated in both lips. Here, 'number analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Restylane Kysse | Percentage of Responders With At Least Improved on the Wrinkle Assessment Scale (WAS) | Upper perioral rhytids; Week 16 | 100 percentage of participants |
| Restylane Kysse | Percentage of Responders With At Least Improved on the Wrinkle Assessment Scale (WAS) | Upper perioral rhytids; Week 24 | 100.0 percentage of participants |
| Restylane Kysse | Percentage of Responders With At Least Improved on the Wrinkle Assessment Scale (WAS) | Upper perioral rhytids; Week 40 | 100.0 percentage of participants |
| Restylane Kysse | Percentage of Responders With At Least Improved on the Wrinkle Assessment Scale (WAS) | Upper perioral rhytids; Week 48 | 100.0 percentage of participants |
| Restylane Kysse | Percentage of Responders With At Least Improved on the Wrinkle Assessment Scale (WAS) | Left oral commissures; Week 8 | 92.3 percentage of participants |
| Restylane Kysse | Percentage of Responders With At Least Improved on the Wrinkle Assessment Scale (WAS) | Left oral commissures; Week 16 | 100.0 percentage of participants |
| Restylane Kysse | Percentage of Responders With At Least Improved on the Wrinkle Assessment Scale (WAS) | Left oral commissures; Week 24 | 90.9 percentage of participants |
| Restylane Kysse | Percentage of Responders With At Least Improved on the Wrinkle Assessment Scale (WAS) | Left oral commissures; Week 32 | 91.7 percentage of participants |
| Restylane Kysse | Percentage of Responders With At Least Improved on the Wrinkle Assessment Scale (WAS) | Left oral commissures; Week 40 | 100.0 percentage of participants |
| Restylane Kysse | Percentage of Responders With At Least Improved on the Wrinkle Assessment Scale (WAS) | Left oral commissures; Week 48 | 100.0 percentage of participants |
| Restylane Kysse | Percentage of Responders With At Least Improved on the Wrinkle Assessment Scale (WAS) | Right oral commissures; Week 8 | 92.3 percentage of participants |
| Restylane Kysse | Percentage of Responders With At Least Improved on the Wrinkle Assessment Scale (WAS) | Right oral commissures; Week 16 | 100.0 percentage of participants |
| Restylane Kysse | Percentage of Responders With At Least Improved on the Wrinkle Assessment Scale (WAS) | Right oral commissures; Week 24 | 90.9 percentage of participants |
| Restylane Kysse | Percentage of Responders With At Least Improved on the Wrinkle Assessment Scale (WAS) | Right oral commissures; Week 32 | 91.7 percentage of participants |
| Restylane Kysse | Percentage of Responders With At Least Improved on the Wrinkle Assessment Scale (WAS) | Right oral commissures; Week 40 | 100.0 percentage of participants |
| Restylane Kysse | Percentage of Responders With At Least Improved on the Wrinkle Assessment Scale (WAS) | Right oral commissures; Week 48 | 100.0 percentage of participants |
| Restylane Kysse | Percentage of Responders With At Least Improved on the Wrinkle Assessment Scale (WAS) | Upper perioral rhytids; Week 8 | 100 percentage of participants |
| Restylane Kysse | Percentage of Responders With At Least Improved on the Wrinkle Assessment Scale (WAS) | Upper perioral rhytids; Week 32 | 100.0 percentage of participants |