Open-label, phase IV, post-marketing study to evaluate aesthetic improvement in Chinese subjects after treatment with Restylane Kysse.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Hyaluronic Acid: Injectable gel for lip augmentation and the correction of upper perioral rhytids
Galderma Research Site
Los Angeles, California, United States
Galderma Research Site
Vista, California, United States
Galderma Research Site
Ardmore, Pennsylvania, United States
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
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
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
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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 48 weeks after last injection (up to 52 weeks)
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
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