Nasolabial Fold Contour Deficiencies, Wrinkles
Conditions
Brief summary
Study is designed to assess the long-term safety of Sculptra Aesthetic in immune-competent subjects as a single regimen for correction of nasolabial fold (NLF) contour deficiencies and other facial wrinkles.
Interventions
DEVICEinjectable poly-L-lactic acid Sculptra Aesthetic
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1\. Subjects seeking correction of shallow to deep NLF contour deficiencies.
Exclusion criteria
1. Subjects seeking, at entry into the study, correction of other facial wrinkles with Sculptra Aesthetic in the following anatomical sites/lines: horizontal forehead lines, glabellar frown lines, periorbital lines, periauricular lines, upper lip lines, lower lip lines, corner of the mouth lines and/or horizontal neck folds. 2. Subjects that are less than 18 or greater than 75 years of age.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Any Injection Site Nodule and/or Papule | Up to 5 years | 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. |
| Percentage of Participants With Any Adverse Events of Interest (AEIs) | Up to 5 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Nasolabial Folds (NLF) Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | Baseline, Months 6,13 and Years 2,3 4,5 | 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. |
| Change From Baseline in Cheek Folds Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | Baseline, Months 6,13 and Years 2,3 4,5 | 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. |
| Change From Baseline in Marionette Lines Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | Baseline, Months 6,13 and Years 2,3 4,5 | 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. |
| Change From Baseline in Chin Crease Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | Baseline, Months 6,13 and Years 2,3 4,5 | 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. |
| Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale | At 6,13 months, 2, 3, 4 and 5 years | 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. |
| Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale | At 6,13 months, 2, 3, 4 and 5 years | 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). |
Countries
United States
Participant flow
Recruitment details
The study was conducted at United States from 21 May 2015 to 28 May 2021.
Pre-assignment details
A total of 867 participants were enrolled and treated in this study.
Participants by arm
| Arm | Count |
|---|---|
| Fitzpatrick Skin Type I-III Participants with Fitzpatrick Skin Type I-III received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 mL deep dermal injections in a grid pattern, spaced at a distance of approximately 1 cm for up to 9 weeks. | 557 |
| Fitzpatrick Skin Type IV-VI Participants with Fitzpatrick Skin Type IV-VI received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 mL deep dermal injections in a grid pattern, spaced at a distance of approximately 1 cm for up to 9 weeks. | 310 |
| Total | 867 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 1 |
| Overall Study | Lost to Follow-up | 59 | 37 |
| Overall Study | Other | 6 | 0 |
| Overall Study | Protocol Violation | 4 | 1 |
| Overall Study | Withdrawal by Subject | 64 | 31 |
Baseline characteristics
| Characteristic | Fitzpatrick Skin Type IV-VI | Total | Fitzpatrick Skin Type I-III |
|---|---|---|---|
| Age, Continuous | 52.6 years STANDARD_DEVIATION 9.56 | 54.6 years STANDARD_DEVIATION 9.48 | 55.7 years STANDARD_DEVIATION 9.25 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 123 Participants | 177 Participants | 54 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 187 Participants | 690 Participants | 503 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Classification Skin Type Type I | 0 Participants | 32 Participants | 32 Participants |
| Fitzpatrick Classification Skin Type Type II | 0 Participants | 212 Participants | 212 Participants |
| Fitzpatrick Classification Skin Type Type III | 0 Participants | 313 Participants | 313 Participants |
| Fitzpatrick Classification Skin Type Type IV | 168 Participants | 168 Participants | 0 Participants |
| Fitzpatrick Classification Skin Type Type V | 96 Participants | 96 Participants | 0 Participants |
| Fitzpatrick Classification Skin Type Type VI | 46 Participants | 46 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 5 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 14 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 88 Participants | 88 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) White | 203 Participants | 754 Participants | 551 Participants |
| Sex: Female, Male Female | 272 Participants | 796 Participants | 524 Participants |
| Sex: Female, Male Male | 38 Participants | 71 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 557 | 1 / 310 |
| other Total, other adverse events | 315 / 557 | 150 / 310 |
| serious Total, serious adverse events | 39 / 557 | 11 / 310 |
Outcome results
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.
Time frame: Up to 5 years
Population: ITT Population included all participants who receive at least one injection of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fitzpatrick Skin Types I-III | Percentage of Participants With Any Adverse Events of Interest (AEIs) | 30.9 Percentage of participants |
| Fitzpatrick Skin Type IV-VI | Percentage of Participants With Any Adverse Events of Interest (AEIs) | 25.8 Percentage of participants |
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.
Time frame: Up to 5 years
Population: Intent to treat (ITT) Population included all participants who received at least one injection of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fitzpatrick Skin Types I-III | Percentage of Participants With Any Injection Site Nodule and/or Papule | 30.52 percentage of participants |
| Fitzpatrick Skin Type IV-VI | Percentage of Participants With Any Injection Site Nodule and/or Papule | 24.84 percentage of participants |
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.
Time frame: Baseline, Months 6,13 and Years 2,3 4,5
Population: ITT Population included all participants who received at least one injection of study drug. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fitzpatrick Skin Types I-III | Change From Baseline in Cheek Folds Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Month 6 | -1.54 Score on a scale | Standard Deviation 0.835 |
| Fitzpatrick Skin Types I-III | Change From Baseline in Cheek Folds Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Month 13 | -1.49 Score on a scale | Standard Deviation 0.924 |
| Fitzpatrick Skin Types I-III | Change From Baseline in Cheek Folds Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Year 2 | -1.47 Score on a scale | Standard Deviation 0.935 |
| Fitzpatrick Skin Types I-III | Change From Baseline in Cheek Folds Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Year 3 | -1.30 Score on a scale | Standard Deviation 1.038 |
| Fitzpatrick Skin Types I-III | Change From Baseline in Cheek Folds Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Year 4 | -0.93 Score on a scale | Standard Deviation 1.179 |
| Fitzpatrick Skin Types I-III | Change From Baseline in Cheek Folds Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Year 5 | -0.62 Score on a scale | Standard Deviation 1.255 |
| Fitzpatrick Skin Type IV-VI | Change From Baseline in Cheek Folds Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Year 4 | -1.38 Score on a scale | Standard Deviation 1.044 |
| Fitzpatrick Skin Type IV-VI | Change From Baseline in Cheek Folds Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Month 6 | -1.88 Score on a scale | Standard Deviation 0.988 |
| Fitzpatrick Skin Type IV-VI | Change From Baseline in Cheek Folds Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Year 3 | -1.74 Score on a scale | Standard Deviation 0.818 |
| Fitzpatrick Skin Type IV-VI | Change From Baseline in Cheek Folds Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Month 13 | -1.96 Score on a scale | Standard Deviation 0.849 |
| Fitzpatrick Skin Type IV-VI | Change From Baseline in Cheek Folds Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Year 5 | -1.08 Score on a scale | Standard Deviation 1.283 |
| Fitzpatrick Skin Type IV-VI | Change From Baseline in Cheek Folds Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Year 2 | -1.89 Score on a scale | Standard Deviation 0.801 |
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.
Time frame: Baseline, Months 6,13 and Years 2,3 4,5
Population: ITT Population included all participants who received at least one injection of study drug. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fitzpatrick Skin Types I-III | Change From Baseline in Chin Crease Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Year 2 | -1.37 Score on a scale | Standard Deviation 1.029 |
| Fitzpatrick Skin Types I-III | Change From Baseline in Chin Crease Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Month 6 | -1.54 Score on a scale | Standard Deviation 0.945 |
| Fitzpatrick Skin Types I-III | Change From Baseline in Chin Crease Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Year 3 | -0.99 Score on a scale | Standard Deviation 1.066 |
| Fitzpatrick Skin Types I-III | Change From Baseline in Chin Crease Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Year 5 | -0.40 Score on a scale | Standard Deviation 1.172 |
| Fitzpatrick Skin Types I-III | Change From Baseline in Chin Crease Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Year 4 | -0.75 Score on a scale | Standard Deviation 1.075 |
| Fitzpatrick Skin Types I-III | Change From Baseline in Chin Crease Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Month 13 | -1.46 Score on a scale | Standard Deviation 0.992 |
| Fitzpatrick Skin Type IV-VI | Change From Baseline in Chin Crease Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Year 4 | -0.86 Score on a scale | Standard Deviation 1.014 |
| Fitzpatrick Skin Type IV-VI | Change From Baseline in Chin Crease Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Year 5 | -0.49 Score on a scale | Standard Deviation 1.048 |
| Fitzpatrick Skin Type IV-VI | Change From Baseline in Chin Crease Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Month 6 | -1.72 Score on a scale | Standard Deviation 0.861 |
| Fitzpatrick Skin Type IV-VI | Change From Baseline in Chin Crease Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Year 2 | -1.61 Score on a scale | Standard Deviation 0.987 |
| Fitzpatrick Skin Type IV-VI | Change From Baseline in Chin Crease Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Year 3 | -1.22 Score on a scale | Standard Deviation 1.027 |
| Fitzpatrick Skin Type IV-VI | Change From Baseline in Chin Crease Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Month 13 | -1.71 Score on a scale | Standard Deviation 0.921 |
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.
Time frame: Baseline, Months 6,13 and Years 2,3 4,5
Population: ITT Population included all participants who received at least one injection of study drug. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fitzpatrick Skin Types I-III | Change From Baseline in Marionette Lines Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Month 13 | -1.65 Score on a scale | Standard Deviation 0.866 |
| Fitzpatrick Skin Types I-III | Change From Baseline in Marionette Lines Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Year 3 | -1.13 Score on a scale | Standard Deviation 1.023 |
| Fitzpatrick Skin Types I-III | Change From Baseline in Marionette Lines Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Month 6 | -1.72 Score on a scale | Standard Deviation 0.831 |
| Fitzpatrick Skin Types I-III | Change From Baseline in Marionette Lines Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Year 2 | -1.52 Score on a scale | Standard Deviation 0.904 |
| Fitzpatrick Skin Types I-III | Change From Baseline in Marionette Lines Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Year 5 | -0.41 Score on a scale | Standard Deviation 1.11 |
| Fitzpatrick Skin Types I-III | Change From Baseline in Marionette Lines Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Year 4 | -0.77 Score on a scale | Standard Deviation 1.077 |
| Fitzpatrick Skin Type IV-VI | Change From Baseline in Marionette Lines Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Year 5 | -0.50 Score on a scale | Standard Deviation 0.945 |
| Fitzpatrick Skin Type IV-VI | Change From Baseline in Marionette Lines Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Month 6 | -1.87 Score on a scale | Standard Deviation 0.798 |
| Fitzpatrick Skin Type IV-VI | Change From Baseline in Marionette Lines Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Month 13 | -1.76 Score on a scale | Standard Deviation 0.825 |
| Fitzpatrick Skin Type IV-VI | Change From Baseline in Marionette Lines Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Year 2 | -1.59 Score on a scale | Standard Deviation 0.858 |
| Fitzpatrick Skin Type IV-VI | Change From Baseline in Marionette Lines Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Year 3 | -1.24 Score on a scale | Standard Deviation 1.003 |
| Fitzpatrick Skin Type IV-VI | Change From Baseline in Marionette Lines Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Year 4 | -0.93 Score on a scale | Standard Deviation 0.989 |
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.
Time frame: Baseline, Months 6,13 and Years 2,3 4,5
Population: ITT Population included all participants who received at least one injection of study drug. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fitzpatrick Skin Types I-III | Change From Baseline in Nasolabial Folds (NLF) Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Month 13 | -1.74 Score on a scale | Standard Deviation 0.785 |
| Fitzpatrick Skin Types I-III | Change From Baseline in Nasolabial Folds (NLF) Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Year 2 | -1.60 Score on a scale | Standard Deviation 0.833 |
| Fitzpatrick Skin Types I-III | Change From Baseline in Nasolabial Folds (NLF) Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Year 4 | -0.80 Score on a scale | Standard Deviation 0.927 |
| Fitzpatrick Skin Types I-III | Change From Baseline in Nasolabial Folds (NLF) Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Year 3 | -1.16 Score on a scale | Standard Deviation 0.908 |
| Fitzpatrick Skin Types I-III | Change From Baseline in Nasolabial Folds (NLF) Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Year 5 | -0.47 Score on a scale | Standard Deviation 0.883 |
| Fitzpatrick Skin Types I-III | Change From Baseline in Nasolabial Folds (NLF) Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Month 6 | -1.73 Score on a scale | Standard Deviation 0.826 |
| Fitzpatrick Skin Type IV-VI | Change From Baseline in Nasolabial Folds (NLF) Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Year 5 | -0.62 Score on a scale | Standard Deviation 0.994 |
| Fitzpatrick Skin Type IV-VI | Change From Baseline in Nasolabial Folds (NLF) Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Year 2 | -1.63 Score on a scale | Standard Deviation 0.836 |
| Fitzpatrick Skin Type IV-VI | Change From Baseline in Nasolabial Folds (NLF) Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Year 3 | -1.25 Score on a scale | Standard Deviation 0.937 |
| Fitzpatrick Skin Type IV-VI | Change From Baseline in Nasolabial Folds (NLF) Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Month 6 | -1.82 Score on a scale | Standard Deviation 0.847 |
| Fitzpatrick Skin Type IV-VI | Change From Baseline in Nasolabial Folds (NLF) Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Month 13 | -1.70 Score on a scale | Standard Deviation 0.801 |
| Fitzpatrick Skin Type IV-VI | Change From Baseline in Nasolabial Folds (NLF) Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 | At Year 4 | -0.95 Score on a scale | Standard Deviation 0.916 |
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.
Time frame: At 6,13 months, 2, 3, 4 and 5 years
Population: ITT Population included all participants who receive at least one injection of study drug. Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and here number analyzed signifies participants who were evaluable for this outcome measure for given time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fitzpatrick Skin Types I-III | Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale | Month 13 : Not Improved | 0.8 percentage of participants |
| Fitzpatrick Skin Types I-III | Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale | Year 5 : Not Improved | 30.4 percentage of participants |
| Fitzpatrick Skin Types I-III | Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale | Year 2 : Improved | 96.6 percentage of participants |
| Fitzpatrick Skin Types I-III | Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale | Month 6 : Improved | 99.4 percentage of participants |
| Fitzpatrick Skin Types I-III | Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale | Year 2 : Not Improved | 3.4 percentage of participants |
| Fitzpatrick Skin Types I-III | Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale | Year 5 : Improved | 69.6 percentage of participants |
| Fitzpatrick Skin Types I-III | Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale | Year 3 : Improved | 90.6 percentage of participants |
| Fitzpatrick Skin Types I-III | Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale | Year 3 : Not Improved | 9.4 percentage of participants |
| Fitzpatrick Skin Types I-III | Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale | Month 6 : Not Improved | 0.6 percentage of participants |
| Fitzpatrick Skin Types I-III | Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale | Year 4 : Improved | 80.6 percentage of participants |
| Fitzpatrick Skin Types I-III | Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale | Month 13 : Improved | 99.2 percentage of participants |
| Fitzpatrick Skin Types I-III | Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale | Year 4 : Not Improved | 19.4 percentage of participants |
| Fitzpatrick Skin Type IV-VI | Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale | Year 5 : Not Improved | 32.5 percentage of participants |
| Fitzpatrick Skin Type IV-VI | Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale | Year 3 : Improved | 92.3 percentage of participants |
| Fitzpatrick Skin Type IV-VI | Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale | Year 4 : Improved | 82.9 percentage of participants |
| Fitzpatrick Skin Type IV-VI | Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale | Year 5 : Improved | 67.5 percentage of participants |
| Fitzpatrick Skin Type IV-VI | Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale | Month 6 : Improved | 99.6 percentage of participants |
| Fitzpatrick Skin Type IV-VI | Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale | Month 13 : Improved | 99.6 percentage of participants |
| Fitzpatrick Skin Type IV-VI | Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale | Month 13 : Not Improved | 0.4 percentage of participants |
| Fitzpatrick Skin Type IV-VI | Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale | Year 2 : Improved | 96.0 percentage of participants |
| Fitzpatrick Skin Type IV-VI | Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale | Year 2 : Not Improved | 4.0 percentage of participants |
| Fitzpatrick Skin Type IV-VI | Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale | Year 3 : Not Improved | 7.7 percentage of participants |
| Fitzpatrick Skin Type IV-VI | Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale | Year 4 : Not Improved | 17.1 percentage of participants |
| Fitzpatrick Skin Type IV-VI | Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale | Month 6 : Not Improved | 0.4 percentage of participants |
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).
Time frame: At 6,13 months, 2, 3, 4 and 5 years
Population: ITT Population included all participants who receive at least one injection of study drug. Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and here number analyzed signifies participants who were evaluable for this outcome measure for given time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fitzpatrick Skin Types I-III | Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale | At Month 13 : Improved | 97.4 percentage of participants |
| Fitzpatrick Skin Types I-III | Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale | At Year 3 : Improved | 85.6 percentage of participants |
| Fitzpatrick Skin Types I-III | Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale | At Month 13 : Not Improved | 2.6 percentage of participants |
| Fitzpatrick Skin Types I-III | Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale | At Year 3: Not Improved | 14.4 percentage of participants |
| Fitzpatrick Skin Types I-III | Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale | At Year 4 : Improved | 73.0 percentage of participants |
| Fitzpatrick Skin Types I-III | Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale | At Month 6 : Improved | 97.2 percentage of participants |
| Fitzpatrick Skin Types I-III | Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale | At Year 4 : Not Improved | 27.0 percentage of participants |
| Fitzpatrick Skin Types I-III | Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale | At Year 2 : Improved | 91.0 percentage of participants |
| Fitzpatrick Skin Types I-III | Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale | At Year 5 : Improved | 66.3 percentage of participants |
| Fitzpatrick Skin Types I-III | Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale | At Year 2: Not Improved | 9.0 percentage of participants |
| Fitzpatrick Skin Types I-III | Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale | At Year 5: Not Improved | 33.7 percentage of participants |
| Fitzpatrick Skin Types I-III | Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale | At Month 6 : Not Improved | 2.8 percentage of participants |
| Fitzpatrick Skin Type IV-VI | Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale | At Year 5: Not Improved | 33.8 percentage of participants |
| Fitzpatrick Skin Type IV-VI | Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale | At Month 6 : Not Improved | 2.2 percentage of participants |
| Fitzpatrick Skin Type IV-VI | Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale | At Year 3: Not Improved | 12.0 percentage of participants |
| Fitzpatrick Skin Type IV-VI | Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale | At Month 6 : Improved | 97.8 percentage of participants |
| Fitzpatrick Skin Type IV-VI | Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale | At Month 13 : Improved | 97.4 percentage of participants |
| Fitzpatrick Skin Type IV-VI | Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale | At Month 13 : Not Improved | 2.6 percentage of participants |
| Fitzpatrick Skin Type IV-VI | Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale | At Year 2 : Improved | 92.9 percentage of participants |
| Fitzpatrick Skin Type IV-VI | Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale | At Year 2: Not Improved | 7.1 percentage of participants |
| Fitzpatrick Skin Type IV-VI | Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale | At Year 3 : Improved | 88.0 percentage of participants |
| Fitzpatrick Skin Type IV-VI | Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale | At Year 4 : Improved | 76.8 percentage of participants |
| Fitzpatrick Skin Type IV-VI | Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale | At Year 4 : Not Improved | 23.2 percentage of participants |
| Fitzpatrick Skin Type IV-VI | Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale | At Year 5 : Improved | 66.3 percentage of participants |