Cheek, Wrinkle
Conditions
Brief summary
To evaluate long-term safety and effectiveness data of Sculptra Aesthetic beyond the Month 12 duration of the pivotal study 43USSA1812 (NCT04124692) to help characterize the long-term safety and effectiveness profile of the more dilute suspension.
Interventions
DEVICESculptra Aethestic reconsituted with 8ml Sterile Water for Injection
Sculptra Aesthetic 8ml and Lidocaine treatment of cheek wrinkles
Sponsors
Galderma R&D
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Subjects originally randomized to Control Group at baseline in the pivotal 43USSA1812 study will be offered treatment with Sculptra Aesthetic in the extension study. Subjects originally randomized to Treatment Group at baseline in the pivotal 43USSA1812 study will be continued to be followed up during the extension study without further treatment.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Subject completed Month 12 of study 43USSA1812 2. Subjects willing to comply with the requirements of the extension of the study and providing a signed written informed consent.
Exclusion criteria
1\. For subjects eligible for treatment in the extension study, the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Cheek Wrinkles Scale (GCWS) at Rest | At Months 19, 21 and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline on the GCWS, on both sides of the face, concurrently. GCWS is a validated 5-point scale used to assess the severity of cheek wrinkles on as scale of 0 to 4. Higher score means more severe (worse) wrinkles. The participant was to have a relaxed face during the assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With At Least Improved on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment | At Months 19, 21 and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | GAIS responder rates are based on independent assessments by the participant. Responder rate was defined as the percentage of participants with at least Improved when compared to baseline before first treatment. The 7-graded GAIS was used by the participant to rate their aesthetic improvement of the cheek wrinkles on a scale from Very Much Improved to Very Much Worse in a live assessment. |
| Percentage of Participants With At Least Improved on the GAIS Based on the Investigator Live Assessment | At Months 19, 21 and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | GAIS responder rates are based on independent assessments by the investigator. Responder rate was defined as the percentage of participants with at least Improved when compared to baseline before first treatment. The 7-graded GAIS was used by the investigator to rate aesthetic improvement of the cheek wrinkles on a scale from Very Much Improved to Very Much Worse in a live assessment. |
| Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied. |
| Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied. |
| Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied. |
| Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied. |
| Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied. |
| Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied. |
| Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied. |
| Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline on the GCWS, on both sides of the face, concurrently. GCWS is a validated 5-point scale used to assess the severity of cheek wrinkles on a scale of 0 to 4. Higher score means more severe (worse) wrinkles. The participant was to have a closed maximum smile during the assessment. |
| Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. |
| Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied. |
| Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | A 5-point subject satisfaction questionnaire with the following responses: Strongly agree, Agree, Neither agree or Disagree, Disagree, Strongly disagree. |
| Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | A 5-point subject satisfaction questionnaire with the following responses: Strongly agree, Agree, Neither Agree or Disagree, Disagree, Strongly Disagree. |
| Subject Satisfaction: Would You Recommend the Treatment to a Friend? | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | A subject satisfaction question with responses Yes or No. |
| Subject Satisfaction: Would You do the Treatment Again? | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | A subject satisfaction question with responses Yes or No. |
| Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores | Baseline, Months 19, 21 and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | The participant assessed satisfaction using the 5 questions on the FACE-Q: Satisfaction with Cheeks Appearance questionnaire measured on a 4-point scale. The responses to the items were converted to a 100-point Rasch transformed total score with 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A negative change from baseline indicates less improvement. |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | From start of study drug administration up to end of the study (up to Month 24) (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs with a start date on or after the first dose of investigational product or a start date before the date of the first dose of investigational product that increased in severity or after the date of the first dose. A SAE was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality/birth defect, and was an important. medical event. TEAEs included both serious and non-serious TEAEs. |
| Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks) | A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied. |
Countries
United States
Participant flow
Recruitment details
The study was conducted at 13 sites at the United States.
Pre-assignment details
A total of 111 participants were enrolled in this extension study upon completion of 43USSA1812 (NCT04124692) study.
Participants by arm
| Arm | Count |
|---|---|
| Group A: Sculptra Aesthetic Participants in this group were treated with Sculptra aesthetic. Participants were followed for up to 12 months for safety and effectiveness data collection in this study. | 39 |
| Group B: No Treatment Participants in this group followed for long-term safety and effectiveness with no additional treatment. Participants were followed for up to 12 months for safety and effectiveness data collection in this study. | 72 |
| Total | 111 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 5 |
| Overall Study | Medical reason | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Group B: No Treatment | Total | Group A: Sculptra Aesthetic |
|---|---|---|---|
| Age, Continuous | 60.8 years STANDARD_DEVIATION 8.06 | 60.4 years STANDARD_DEVIATION 7.85 | 59.5 years STANDARD_DEVIATION 7.46 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 8 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 69 Participants | 103 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick skin type (FST) FST I | 3 Participants | 4 Participants | 1 Participants |
| Fitzpatrick skin type (FST) FST II | 18 Participants | 32 Participants | 14 Participants |
| Fitzpatrick skin type (FST) FST III | 36 Participants | 52 Participants | 16 Participants |
| Fitzpatrick skin type (FST) FST IV | 8 Participants | 12 Participants | 4 Participants |
| Fitzpatrick skin type (FST) FST V | 4 Participants | 7 Participants | 3 Participants |
| Fitzpatrick skin type (FST) FST VI | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 9 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 64 Participants | 100 Participants | 36 Participants |
| Sex: Female, Male Female | 69 Participants | 107 Participants | 38 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 72 |
| other Total, other adverse events | 11 / 39 | 4 / 72 |
| serious Total, serious adverse events | 0 / 39 | 1 / 72 |
Outcome results
Primary
Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Cheek Wrinkles Scale (GCWS) at Rest
Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline on the GCWS, on both sides of the face, concurrently. GCWS is a validated 5-point scale used to assess the severity of cheek wrinkles on as scale of 0 to 4. Higher score means more severe (worse) wrinkles. The participant was to have a relaxed face during the assessment.
Time frame: At Months 19, 21 and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Population: The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given timepoints.~(4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A: Sculptra Aesthetic | Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Cheek Wrinkles Scale (GCWS) at Rest | At Month 19 | 33.3 Percentage of participants |
| Group A: Sculptra Aesthetic | Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Cheek Wrinkles Scale (GCWS) at Rest | At Month 21 | 36.8 Percentage of participants |
| Group A: Sculptra Aesthetic | Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Cheek Wrinkles Scale (GCWS) at Rest | At Month 24 | 42.1 Percentage of participants |
| Group B: No Treatment | Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Cheek Wrinkles Scale (GCWS) at Rest | At Month 19 | 84.8 Percentage of participants |
| Group B: No Treatment | Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Cheek Wrinkles Scale (GCWS) at Rest | At Month 21 | 76.9 Percentage of participants |
| Group B: No Treatment | Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Cheek Wrinkles Scale (GCWS) at Rest | At Month 24 | 76.9 Percentage of participants |
Secondary
Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores
The participant assessed satisfaction using the 5 questions on the FACE-Q: Satisfaction with Cheeks Appearance questionnaire measured on a 4-point scale. The responses to the items were converted to a 100-point Rasch transformed total score with 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A negative change from baseline indicates less improvement.
Time frame: Baseline, Months 19, 21 and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Population: The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given timepoints.~(4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: Sculptra Aesthetic | Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores | At Month 19 | 42.9 score on a scale | Standard Deviation 29.73 |
| Group A: Sculptra Aesthetic | Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores | At Month 21 | 44 score on a scale | Standard Deviation 28.41 |
| Group A: Sculptra Aesthetic | Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores | At Month 24 | 45.3 score on a scale | Standard Deviation 32.91 |
| Group B: No Treatment | Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores | At Month 19 | 34.9 score on a scale | Standard Deviation 37 |
| Group B: No Treatment | Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores | At Month 21 | 38.7 score on a scale | Standard Deviation 27.98 |
| Group B: No Treatment | Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores | At Month 24 | 36.8 score on a scale | Standard Deviation 30.69 |
Secondary
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs with a start date on or after the first dose of investigational product or a start date before the date of the first dose of investigational product that increased in severity or after the date of the first dose. A SAE was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality/birth defect, and was an important. medical event. TEAEs included both serious and non-serious TEAEs.
Time frame: From start of study drug administration up to end of the study (up to Month 24) (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Population: The extension population included all participants entering the extension study. (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A: Sculptra Aesthetic | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | Serious TEAEs | 0 Participants |
| Group A: Sculptra Aesthetic | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | TEAEs | 17 Participants |
| Group B: No Treatment | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | TEAEs | 15 Participants |
| Group B: No Treatment | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | Serious TEAEs | 1 Participants |
Secondary
Percentage of Participants With At Least Improved on the GAIS Based on the Investigator Live Assessment
GAIS responder rates are based on independent assessments by the investigator. Responder rate was defined as the percentage of participants with at least Improved when compared to baseline before first treatment. The 7-graded GAIS was used by the investigator to rate aesthetic improvement of the cheek wrinkles on a scale from Very Much Improved to Very Much Worse in a live assessment.
Time frame: At Months 19, 21 and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Population: The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given timepoints.~(4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A: Sculptra Aesthetic | Percentage of Participants With At Least Improved on the GAIS Based on the Investigator Live Assessment | At Month 19 | 97.2 Percentage of participants |
| Group A: Sculptra Aesthetic | Percentage of Participants With At Least Improved on the GAIS Based on the Investigator Live Assessment | At Month 21 | 97.4 Percentage of participants |
| Group A: Sculptra Aesthetic | Percentage of Participants With At Least Improved on the GAIS Based on the Investigator Live Assessment | At Month 24 | 92.3 Percentage of participants |
| Group B: No Treatment | Percentage of Participants With At Least Improved on the GAIS Based on the Investigator Live Assessment | At Month 19 | 97.0 Percentage of participants |
| Group B: No Treatment | Percentage of Participants With At Least Improved on the GAIS Based on the Investigator Live Assessment | At Month 21 | 96.9 Percentage of participants |
| Group B: No Treatment | Percentage of Participants With At Least Improved on the GAIS Based on the Investigator Live Assessment | At Month 24 | 93.8 Percentage of participants |
Secondary
Percentage of Participants With At Least Improved on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment
GAIS responder rates are based on independent assessments by the participant. Responder rate was defined as the percentage of participants with at least Improved when compared to baseline before first treatment. The 7-graded GAIS was used by the participant to rate their aesthetic improvement of the cheek wrinkles on a scale from Very Much Improved to Very Much Worse in a live assessment.
Time frame: At Months 19, 21 and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Population: The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given timepoints.~(4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A: Sculptra Aesthetic | Percentage of Participants With At Least Improved on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment | At Month 19 | 97.2 Percentage of participants |
| Group A: Sculptra Aesthetic | Percentage of Participants With At Least Improved on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment | At Month 21 | 97.4 Percentage of participants |
| Group A: Sculptra Aesthetic | Percentage of Participants With At Least Improved on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment | At Month 24 | 92.3 Percentage of participants |
| Group B: No Treatment | Percentage of Participants With At Least Improved on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment | At Month 19 | 97.0 Percentage of participants |
| Group B: No Treatment | Percentage of Participants With At Least Improved on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment | At Month 21 | 96.9 Percentage of participants |
| Group B: No Treatment | Percentage of Participants With At Least Improved on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment | At Month 24 | 93.8 Percentage of participants |
Secondary
Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic
Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline on the GCWS, on both sides of the face, concurrently. GCWS is a validated 5-point scale used to assess the severity of cheek wrinkles on a scale of 0 to 4. Higher score means more severe (worse) wrinkles. The participant was to have a closed maximum smile during the assessment.
Time frame: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Population: The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given timepoints.~(4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A: Sculptra Aesthetic | Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic | At Month 19 | 41.7 Percentage of participants |
| Group A: Sculptra Aesthetic | Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic | At Month 21 | 44.7 Percentage of participants |
| Group A: Sculptra Aesthetic | Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic | At Month 24 | 50 Percentage of participants |
| Group B: No Treatment | Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic | At Month 19 | 77.3 Percentage of participants |
| Group B: No Treatment | Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic | At Month 21 | 75.4 Percentage of participants |
| Group B: No Treatment | Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic | At Month 24 | 73.8 Percentage of participants |
Secondary
Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Time frame: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Population: The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given timepoints.~(4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 19 | Not Satisfied | 2 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 21 | Satisfactory | 5 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 19 | Very Good | 14 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 21 | Not Satisfied | 3 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 21 | Excellent | 7 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 24 | Excellent | 7 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 19 | Satisfactory | 7 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 24 | Very Good | 15 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 21 | Very Good | 9 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 24 | Good | 10 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 19 | Good | 9 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 24 | Satisfactory | 3 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 21 | Good | 14 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 24 | Not Satisfied | 4 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 19 | Excellent | 4 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 24 | Not Satisfied | 7 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 19 | Excellent | 16 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 19 | Very Good | 14 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 19 | Good | 20 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 19 | Satisfactory | 12 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 19 | Not Satisfied | 5 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 21 | Excellent | 16 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 21 | Very Good | 16 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 21 | Good | 16 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 21 | Satisfactory | 13 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 21 | Not Satisfied | 4 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 24 | Excellent | 15 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 24 | Very Good | 13 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 24 | Good | 20 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | At Month 24 | Satisfactory | 10 Participants |
Secondary
Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Time frame: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Population: The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given timepoints.~(4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 19 | Not Satisfied | 2 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 21 | Satisfactory | 7 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 19 | Very good | 10 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 21 | Not Satisfied | 4 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 21 | Excellent | 6 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 24 | Excellent | 7 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 19 | Satisfactory | 7 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 24 | Very good | 14 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 21 | Very good | 9 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 24 | Good | 10 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 19 | Good | 12 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 24 | Satisfactory | 5 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 21 | Good | 12 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 24 | Not Satisfied | 3 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 19 | Excellent | 5 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 24 | Not Satisfied | 7 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 19 | Excellent | 14 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 19 | Very good | 17 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 19 | Good | 17 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 19 | Satisfactory | 16 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 19 | Not Satisfied | 3 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 21 | Excellent | 15 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 21 | Very good | 15 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 21 | Good | 16 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 21 | Satisfactory | 15 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 21 | Not Satisfied | 4 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 24 | Excellent | 14 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 24 | Very good | 12 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 24 | Good | 21 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | At Month 24 | Satisfactory | 11 Participants |
Secondary
Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Time frame: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Population: The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given timepoints.~(4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 19 | Not Satisfied | 3 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 21 | Satisfactory | 5 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 19 | Very good | 12 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 21 | Not Satisfied | 3 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 21 | Excellent | 6 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 24 | Excellent | 7 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 19 | Satisfactory | 5 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 24 | Very good | 14 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 21 | Very good | 14 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 24 | Good | 11 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 19 | Good | 7 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 24 | Satisfactory | 4 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 21 | Good | 10 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 24 | Not Satisfied | 3 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 19 | Excellent | 9 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 24 | Not Satisfied | 7 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 19 | Excellent | 14 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 19 | Very good | 20 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 19 | Good | 17 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 19 | Satisfactory | 12 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 19 | Not Satisfied | 4 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 21 | Excellent | 17 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 21 | Very good | 14 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 21 | Good | 17 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 21 | Satisfactory | 14 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 21 | Not Satisfied | 3 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 24 | Excellent | 17 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 24 | Very good | 10 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 24 | Good | 21 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? | At Month 24 | Satisfactory | 10 Participants |
Secondary
Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Time frame: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Population: The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given timepoints.~(4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 21 | Satisfactory | 6 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 21 | Not Satisfied | 3 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 24 | Excellent | 6 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 24 | Very good | 14 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 24 | Good | 12 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 24 | Satisfactory | 4 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 24 | Not Satisfied | 3 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 19 | Excellent | 7 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 19 | Very good | 9 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 19 | Good | 11 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 19 | Satisfactory | 7 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 19 | Not Satisfied | 2 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 21 | Excellent | 6 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 21 | Very good | 12 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 21 | Good | 11 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 21 | Satisfactory | 16 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 19 | Very good | 18 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 21 | Not Satisfied | 4 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 21 | Excellent | 19 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 24 | Excellent | 18 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 19 | Good | 19 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 24 | Very good | 11 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 21 | Good | 14 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 24 | Good | 19 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 19 | Satisfactory | 13 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 24 | Satisfactory | 11 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 21 | Very good | 12 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 24 | Not Satisfied | 6 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 19 | Not Satisfied | 3 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? | At Month 19 | Excellent | 14 Participants |
Secondary
Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?
A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.
Time frame: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Population: The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given timepoints.~(4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 19 | Not Satisfied | 4 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 21 | Satisfactory | 6 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 19 | Very good | 8 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 21 | Not Satisfied | 4 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 21 | Excellent | 4 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 24 | Excellent | 7 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 19 | Satisfactory | 4 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 24 | Very good | 12 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 21 | Very good | 13 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 24 | Good | 11 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 19 | Good | 13 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 24 | Satisfactory | 5 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 21 | Good | 11 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 24 | Not Satisfied | 4 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 19 | Excellent | 7 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 24 | Not Satisfied | 8 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 19 | Excellent | 14 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 19 | Very good | 13 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 19 | Good | 17 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 19 | Satisfactory | 13 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 19 | Not Satisfied | 10 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 21 | Excellent | 16 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 21 | Very good | 16 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 21 | Good | 15 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 21 | Satisfactory | 12 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 21 | Not Satisfied | 6 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 24 | Excellent | 16 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 24 | Very good | 11 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 24 | Good | 20 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? | At Month 24 | Satisfactory | 10 Participants |
Secondary
Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Time frame: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Population: The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given timepoints.~(4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 19 | Not Satisfied | 2 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 21 | Satisfactory | 7 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 19 | Very Good | 9 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 21 | Not Satisfied | 2 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 21 | Excellent | 6 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 24 | Excellent | 7 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 19 | Satisfactory | 7 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 24 | Very Good | 17 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 21 | Very Good | 11 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 24 | Good | 8 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 19 | Good | 11 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 24 | Satisfactory | 4 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 21 | Good | 12 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 24 | Not Satisfied | 3 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 19 | Excellent | 7 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 24 | Not Satisfied | 5 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 19 | Excellent | 14 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 19 | Very Good | 18 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 19 | Good | 19 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 19 | Satisfactory | 13 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 19 | Not Satisfied | 3 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 21 | Excellent | 16 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 21 | Very Good | 14 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 21 | Good | 17 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 21 | Satisfactory | 15 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 21 | Not Satisfied | 3 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 24 | Excellent | 15 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 24 | Very Good | 13 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 24 | Good | 19 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? | At Month 24 | Satisfactory | 13 Participants |
Secondary
Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Time frame: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Population: The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given timepoints.~(4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 19 | Not Satisfied | 2 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 21 | Satisfactory | 6 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 19 | Excellent | 3 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 21 | Not Satisfied | 4 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 21 | Excellent | 5 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 24 | Excellent | 7 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 19 | Good | 12 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 24 | Very good | 13 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 21 | Very good | 10 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 24 | Good | 11 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 19 | Very good | 12 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 24 | Satisfactory | 5 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 21 | Good | 13 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 24 | Not Satisfied | 3 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 19 | Satisfactory | 7 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 24 | Not Satisfied | 4 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 19 | Satisfactory | 14 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 19 | Excellent | 15 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 19 | Very good | 14 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 19 | Good | 19 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 19 | Not Satisfied | 5 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 21 | Excellent | 16 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 21 | Very good | 13 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 21 | Good | 15 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 21 | Satisfactory | 17 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 21 | Not Satisfied | 4 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 24 | Excellent | 13 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 24 | Very good | 13 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 24 | Good | 20 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | At Month 24 | Satisfactory | 15 Participants |
Secondary
Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Time frame: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Population: The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given timepoints.~(4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 19 | Not Satisfied | 3 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 21 | Satisfactory | 5 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 19 | Very good | 11 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 21 | Not Satisfied | 4 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 21 | Excellent | 4 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 24 | Excellent | 7 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 19 | Satisfactory | 5 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 24 | Very good | 13 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 21 | Very good | 11 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 24 | Good | 11 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 19 | Good | 11 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 24 | Satisfactory | 5 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 21 | Good | 14 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 24 | Not Satisfied | 3 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 19 | Excellent | 6 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 24 | Not Satisfied | 6 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 19 | Excellent | 13 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 19 | Very good | 14 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 19 | Good | 18 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 19 | Satisfactory | 18 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 19 | Not Satisfied | 4 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 21 | Excellent | 16 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 21 | Very good | 13 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 21 | Good | 13 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 21 | Satisfactory | 18 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 21 | Not Satisfied | 5 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 24 | Excellent | 13 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 24 | Very good | 16 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 24 | Good | 16 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | At Month 24 | Satisfactory | 14 Participants |
Secondary
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Time frame: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Population: The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given timepoints.~(4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 21 | Satisfactory | 6 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 19 | Excellent | 8 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 19 | Very good | 8 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 19 | Good | 10 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 19 | Satisfactory | 8 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 19 | Not satisfied | 2 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 21 | Excellent | 6 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 21 | Very good | 12 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 21 | Good | 11 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 21 | Not satisfied | 3 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 24 | Excellent | 7 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 24 | Very good | 14 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 24 | Good | 10 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 24 | Satisfactory | 5 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 24 | Not satisfied | 3 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 24 | Very good | 12 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 21 | Good | 17 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 19 | Excellent | 14 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 21 | Satisfactory | 18 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 19 | Very good | 14 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 24 | Satisfactory | 11 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 19 | Good | 21 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 21 | Not satisfied | 1 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 19 | Satisfactory | 13 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 24 | Good | 21 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 19 | Not satisfied | 5 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 24 | Excellent | 14 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 21 | Excellent | 16 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 24 | Not satisfied | 7 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | At Month 21 | Very good | 13 Participants |
Secondary
Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Time frame: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Population: The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given timepoints.~(4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 19 | Not satisfied | 2 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 21 | Satisfactory | 6 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 19 | Very good | 10 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 21 | Not satisfied | 3 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 21 | Excellent | 7 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 24 | Excellent | 7 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 19 | Satisfactory | 6 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 24 | Very good | 15 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 21 | Very good | 12 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 24 | Good | 9 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 19 | Good | 10 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 24 | Satisfactory | 5 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 21 | Good | 10 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 24 | Not satisfied | 3 Participants |
| Group A: Sculptra Aesthetic | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 19 | Excellent | 8 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 24 | Not satisfied | 5 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 19 | Excellent | 18 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 19 | Very good | 14 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 19 | Good | 13 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 19 | Satisfactory | 17 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 19 | Not satisfied | 5 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 21 | Excellent | 17 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 21 | Very good | 11 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 21 | Good | 19 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 21 | Satisfactory | 14 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 21 | Not satisfied | 4 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 24 | Excellent | 18 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 24 | Very good | 9 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 24 | Good | 20 Participants |
| Group B: No Treatment | Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? | At Month 24 | Satisfactory | 13 Participants |
Secondary
Subject Satisfaction: Would You do the Treatment Again?
A subject satisfaction question with responses Yes or No.
Time frame: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Population: The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given timepoints.~(4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You do the Treatment Again? | At Month 24 | Yes | 34 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You do the Treatment Again? | At Month 19 | Yes | 31 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You do the Treatment Again? | At Month 21 | No | 6 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You do the Treatment Again? | At Month 19 | No | 5 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You do the Treatment Again? | At Month 24 | No | 5 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You do the Treatment Again? | At Month 21 | Yes | 32 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You do the Treatment Again? | At Month 24 | No | 10 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You do the Treatment Again? | At Month 21 | No | 7 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You do the Treatment Again? | At Month 24 | Yes | 55 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You do the Treatment Again? | At Month 21 | Yes | 58 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You do the Treatment Again? | At Month 19 | Yes | 55 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You do the Treatment Again? | At Month 19 | No | 12 Participants |
Secondary
Subject Satisfaction: Would You Recommend the Treatment to a Friend?
A subject satisfaction question with responses Yes or No.
Time frame: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Population: The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given timepoints.~(4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You Recommend the Treatment to a Friend? | At Month 19 | Yes | 34 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You Recommend the Treatment to a Friend? | At Month 19 | No | 2 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You Recommend the Treatment to a Friend? | At Month 21 | Yes | 35 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You Recommend the Treatment to a Friend? | At Month 21 | No | 3 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You Recommend the Treatment to a Friend? | At Month 24 | Yes | 35 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You Recommend the Treatment to a Friend? | At Month 24 | No | 4 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You Recommend the Treatment to a Friend? | At Month 24 | Yes | 55 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You Recommend the Treatment to a Friend? | At Month 19 | Yes | 56 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You Recommend the Treatment to a Friend? | At Month 21 | No | 7 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You Recommend the Treatment to a Friend? | At Month 19 | No | 11 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You Recommend the Treatment to a Friend? | At Month 24 | No | 10 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You Recommend the Treatment to a Friend? | At Month 21 | Yes | 58 Participants |
Secondary
Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?
A 5-point subject satisfaction questionnaire with the following responses: Strongly agree, Agree, Neither agree or Disagree, Disagree, Strongly disagree.
Time frame: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Population: The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given timepoints.~(4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 19 | Agree | 10 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 21 | Disagree | 0 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 19 | Neither Agree or Disagree | 4 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 21 | Strongly Disagree | 0 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 19 | Disagree | 0 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 24 | Strongly agree | 21 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 21 | Strongly agree | 21 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 24 | Agree | 15 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 19 | Strongly agree | 22 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 24 | Neither Agree or Disagree | 3 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 21 | Agree | 13 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 24 | Disagree | 0 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 19 | Strongly Disagree | 0 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 24 | Strongly Disagree | 0 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 21 | Neither Agree or Disagree | 4 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 24 | Strongly Disagree | 0 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 19 | Disagree | 0 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 19 | Strongly Disagree | 0 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 19 | Strongly agree | 37 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 19 | Neither Agree or Disagree | 10 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 21 | Strongly agree | 35 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 21 | Agree | 25 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 21 | Neither Agree or Disagree | 5 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 21 | Disagree | 0 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 21 | Strongly Disagree | 0 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 24 | Strongly agree | 34 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 24 | Agree | 24 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 24 | Neither Agree or Disagree | 7 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 24 | Disagree | 0 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? | At Month 19 | Agree | 20 Participants |
Secondary
Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?
A 5-point subject satisfaction questionnaire with the following responses: Strongly agree, Agree, Neither Agree or Disagree, Disagree, Strongly Disagree.
Time frame: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Population: The extension population included all participants entering the extension study. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given timepoints.~(4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 24 | Strongly agree | 16 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 21 | Neither agree or Disagree | 6 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 19 | Disagree | 0 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 21 | Disagree | 0 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 19 | Agree | 13 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 21 | Strongly disagree | 0 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 19 | Strongly disagree | 0 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 24 | Agree | 19 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 19 | Strongly agree | 17 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 24 | Neither agree or Disagree | 3 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 21 | Strongly agree | 17 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 24 | Disagree | 1 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 19 | Neither agree or Disagree | 6 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 24 | Strongly disagree | 0 Participants |
| Group A: Sculptra Aesthetic | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 21 | Agree | 15 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 24 | Strongly disagree | 1 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 19 | Strongly agree | 30 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 19 | Agree | 21 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 19 | Neither agree or Disagree | 11 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 19 | Disagree | 4 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 19 | Strongly disagree | 1 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 21 | Strongly agree | 27 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 21 | Agree | 29 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 21 | Neither agree or Disagree | 6 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 21 | Disagree | 3 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 24 | Strongly agree | 28 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 24 | Agree | 25 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 24 | Neither agree or Disagree | 9 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 24 | Disagree | 2 Participants |
| Group B: No Treatment | Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? | At Month 21 | Strongly disagree | 0 Participants |