Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Percentage of Participants With Any Injection Site Nodule and/or Papule |
Nodules and/or papules are a subset of AEIs that does not include hypertrophic scarring, keloid formation, changes in skin pigmentation at the site of injection compared to adjacent skin, granuloma (confirmed by a biopsy), skin necrosis, hypersensitivity reactions, and unexpected changes in wrinkle contour. Reporting of a nodule or papule was based on size (nodule greater than or equal to [>=] 0.5 (cm); papule less than [<] 0.5 cm). Percentage of participants with any injection site nodule and/or papule were reported. |
Up to 5 years |
|
| Primary |
Percentage of Participants With Any Adverse Events of Interest (AEIs) |
AEIs means: "serious or non-serious adverse event that is one of scientific and medical concern specific to the sponsor's product for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate. Examples of AEIs were hypertrophic scarring, keloid formation, hypersensitivity reactions, skin necrosis, unexpected change in wrinkle contour, granuloma, changes in the skin pigmentation at the site of injection compared to adjacent. Percentage of participants with any AEIs (other than injection site nodule and/or papule) were reported. |
Up to 5 years |
|
| Secondary |
Change From Baseline in Nasolabial Folds (NLF) Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 |
NLF severity was assessed by the evaluating investigator from WAS. WAS was based on a 6-point assessment grade where 0=no wrinkles; 1=just perceptible wrinkle; 2=shallow wrinkle; 3=moderately deep wrinkle; 4=deep wrinkle, well-defined edges; 5=very deep wrinkle, redundant fold. The calculations for average WAS was based on data corresponding to only the nasolabial folds (NLFs) treated at the initial visit, that is., only WAS scores for treated sides was considered. The average WAS was calculated from the individual left and right NLFs scores. If the WAS was only available for one side, then the average WAS was the score for the one side. |
Baseline, Months 6,13 and Years 2,3 4,5 |
|
| Secondary |
Change From Baseline in Cheek Folds Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 |
The WAS is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds. The physician assessed the left side and the right side of the participant's face using the 5-point scale where scoring of wrinkle severity (grades 0-5, with 0 representing no wrinkles and 5 representing very deep wrinkles, redundant fold) was based on visual live assessment by the investigator at defined timepoints. Higher scores mean a worse outcome. |
Baseline, Months 6,13 and Years 2,3 4,5 |
|
| Secondary |
Change From Baseline in Marionette Lines Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 |
Marionette Lines severity was assessed by the evaluating investigator from WAS. WAS was based on a 6-point assessment grade where 0=no wrinkles; 1=just perceptible wrinkle; 2=shallow wrinkle; 3=moderately deep wrinkle; 4=deep wrinkle, well-defined edges; 5=very deep wrinkle, redundant fold. The calculations for average WAS was based on data corresponding to only the nasolabial folds (NLFs) treated at the initial visit, that is., only WAS scores for treated sides was considered. The average WAS was calculated from the individual left and right NLFs scores. If the WAS was only available for one side, then the average WAS was the score for the one side. |
Baseline, Months 6,13 and Years 2,3 4,5 |
|
| Secondary |
Change From Baseline in Chin Crease Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 |
Chin Crease severity was assessed by the evaluating investigator from WAS. WAS was based on a 6-point assessment grade where 0=no wrinkles; 1=just perceptible wrinkle; 2=shallow wrinkle; 3=moderately deep wrinkle; 4=deep wrinkle, well-defined edges; 5=very deep wrinkle, redundant fold. The calculations for average WAS was based on data corresponding to only the nasolabial folds (NLFs) treated at the initial visit, that is., only WAS scores for treated sides was considered. The average WAS was calculated from the individual left and right NLFs scores. If the WAS was only available for one side, then the average WAS was the score for the one side. |
Baseline, Months 6,13 and Years 2,3 4,5 |
|
| Secondary |
Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale |
Efficacy was assessed by overall facial improvement assessed live by the Investigator assessment of facial appearance including the Global Aesthetic Improvement Scale (GAIS). The Global Aesthetic Improvement Scale is a subjective test. The investigator independently describes the degree of improvement in facial appearance. Possible scores were + 3: Much improved, +2: Moderately improved, +1: Slightly improved, 0: No change, -1: Slightly worse, -2: Moderately worse, -3: Much worse. 'Not Improved' included participants with scores of 0, -1, -2, and -3 and 'Improved' included participants with scores of 3, 2, and 1. Higher the GAIS value, the greater the improvement. |
At 6,13 months, 2, 3, 4 and 5 years |
|
| Secondary |
Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale |
Efficacy was assessed by overall facial improvement assessed live by the participants assessment of facial appearance including the GAIS. The GAIS is a subjective test. The participant independently describes the degree of improvement in facial appearance. Possible scores were + 3: Much improved, +2: Moderately improved, +1: Slightly improved, 0: No change, -1: Slightly worse, -2: Moderately worse, -3: Much worse. 'Not Improved' included participants with scores of 0, -1, -2, and -3 and 'Improved' included participants with scores of 3, 2, and 1. Higher the GAIS value, the greater the improvement (Range 0 to 3). |
At 6,13 months, 2, 3, 4 and 5 years |
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