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Open-label, phase IV, post-marketing study to evaluate aesthetic improvement in Chinese subjects after treatment with Restylane Kysse.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restylane Kysse | Experimental | Hyaluronic Acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane Kysse | Device | Hyaluronic Acid: Injectable gel for lip augmentation and the correction of upper perioral rhytids |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At Week 8 |
| 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. | At Week 16 |
| 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. | At Week 24 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Research Site | Los Angeles | California | 94538 | United States | ||
| Galderma Research Site |
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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.
This study was conducted from 13 June 2022 to 07 November 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The safety population included all participants who were treated with Restylane Kysse in at least 1 lip and were analyzed according to the treatment actually received.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | percentage of participants | At Week 8 |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sponsor | Galderma Research & Development, LLC | 8179615000 | aestheticclinicaltrials@galderma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 1, 2023 | Dec 5, 2025 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 6, 2023 | Dec 5, 2025 | SAP_003.pdf |
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| At Week 32 |
| 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. | At Week 40 |
| 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. | At Week 48 |
| 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. | 8 weeks after last injection (up to 12 weeks) |
| 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. | 16 weeks after last injection (up to 20 weeks) |
| 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. | 24 weeks after last injection (up to 28 weeks) |
| 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. | 32 weeks after last injection (up to 36 weeks) |
| 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. | 40 weeks after last injection (up to 44 weeks) |
| 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. | 48 weeks after last injection (up to 52 weeks) |
| At Weeks 8, 16, 24, 32, 40, and 48 |
| 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. | At Weeks 8, 16, 24, 32, 40, and 48 |
| Vista |
| California |
| 92083 |
| United States |
| Galderma Research Site | Ardmore | Pennsylvania | 19003 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| MLFS-upper lip | Count of Participants | Participants |
|
| MLFS-lower lip | Count of Participants | 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.
|
|
| 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. | 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. | Posted | Number | percentage of participants | At Week 16 |
|
|
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| 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. | 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. | Posted | Number | percentage of participants | At Week 24 |
|
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| 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. | 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. | Posted | Number | percentage of participants | At Week 32 |
|
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| 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. | 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. | Posted | Number | percentage of participants | At Week 40 |
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| 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. | 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. | Posted | Number | percentage of participants | At Week 48 |
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| 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. | 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. | Posted | Count of Participants | Participants | 8 weeks after last injection (up to 12 weeks) |
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| 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. | 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. | Posted | Count of Participants | Participants | 16 weeks after last injection (up to 20 weeks) |
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| 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. | 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. | Posted | Count of Participants | Participants | 24 weeks after last injection (up to 28 weeks) |
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| 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. | 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. | Posted | Count of Participants | Participants | 32 weeks after last injection (up to 36 weeks) |
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| 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. | 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. | Posted | Count of Participants | Participants | 40 weeks after last injection (up to 44 weeks) |
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| 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. | 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. | Posted | Count of Participants | Participants | 48 weeks after last injection (up to 52 weeks) |
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| 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. | The mITT population included all participants who were treated in both lips. Here, 'number analyzed' signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | At Weeks 8, 16, 24, 32, 40, and 48 |
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| 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. | The mITT population included all participants who were treated in both lips. Here, 'number analyzed' signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | At Weeks 8, 16, 24, 32, 40, and 48 |
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|
| 0 |
| 22 |
| 0 |
| 22 |
| 2 |
| 22 |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Systematic Assessment |
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Not provided
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| Three grade improvement |
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| Lower lip |
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| Three grade improvement |
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| Lower lip |
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| Three grade improvement |
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| Lower lip |
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| Three grade improvement |
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| Lower lip |
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| Three grade improvement |
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| Lower lip |
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| Three grade improvement |
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| Lower lip |
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| Upper perioral rhytids; Week 24 |
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| Upper perioral rhytids; Week 32 |
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| Upper perioral rhytids; Week 40 |
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| Upper perioral rhytids; Week 48 |
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| Left oral commissures; Week 8 |
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| Left oral commissures; Week 16 |
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| Left oral commissures; Week 24 |
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| Left oral commissures; Week 32 |
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| Left oral commissures; Week 40 |
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| Left oral commissures; Week 48 |
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| Right oral commissures; Week 8 |
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| Right oral commissures; Week 16 |
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| Right oral commissures; Week 24 |
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| Right oral commissures; Week 32 |
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| Right oral commissures; Week 40 |
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| Right oral commissures; Week 48 |
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| At Week 24 |
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| At Week 32 |
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| At Week 40 |
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| At Week 48 |
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