Trial Outcomes & Findings for Open Label Extension for 43USSA1812 (NCT NCT04595331)
NCT ID: NCT04595331
Last Updated: 2025-06-26
Results Overview
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.
COMPLETED
NA
111 participants
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)
2025-06-26
Participant Flow
The study was conducted at 13 sites at the United States.
A total of 111 participants were enrolled in this extension study upon completion of 43USSA1812 (NCT04124692) study.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
72
|
|
Overall Study
COMPLETED
|
39
|
65
|
|
Overall Study
NOT COMPLETED
|
0
|
7
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
5
|
|
Overall Study
Medical reason
|
0
|
1
|
Baseline Characteristics
Open Label Extension for 43USSA1812
Baseline characteristics by cohort
| Measure |
Group A: Sculptra Aesthetic
n=39 Participants
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.
|
Group B: No Treatment
n=72 Participants
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.
|
Total
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.5 years
STANDARD_DEVIATION 7.46 • n=5 Participants
|
60.8 years
STANDARD_DEVIATION 8.06 • n=7 Participants
|
60.4 years
STANDARD_DEVIATION 7.85 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Fitzpatrick skin type (FST)
FST I
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Fitzpatrick skin type (FST)
FST II
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Fitzpatrick skin type (FST)
FST III
|
16 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Fitzpatrick skin type (FST)
FST IV
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Fitzpatrick skin type (FST)
FST V
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Fitzpatrick skin type (FST)
FST VI
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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)
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.
Outcome measures
| Measure |
Group A: Sculptra Aesthetic
n=38 Participants
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.
|
Group B: No Treatment
n=66 Participants
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.
|
|---|---|---|
|
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
|
84.8 Percentage of participants
|
|
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
|
76.9 Percentage of participants
|
|
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
|
76.9 Percentage of participants
|
SECONDARY outcome
Timeframe: 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)
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.
Outcome measures
| Measure |
Group A: Sculptra Aesthetic
n=38 Participants
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.
|
Group B: No Treatment
n=66 Participants
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.
|
|---|---|---|
|
Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic
At Month 19
|
41.7 Percentage of participants
|
77.3 Percentage of participants
|
|
Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic
At Month 21
|
44.7 Percentage of participants
|
75.4 Percentage of participants
|
|
Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic
At Month 24
|
50 Percentage of participants
|
73.8 Percentage of participants
|
SECONDARY outcome
Timeframe: 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)
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.
Outcome measures
| Measure |
Group A: Sculptra Aesthetic
n=39 Participants
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.
|
Group B: No Treatment
n=66 Participants
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.
|
|---|---|---|
|
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
|
97.0 Percentage of participants
|
|
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
|
96.9 Percentage of participants
|
|
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
|
93.8 Percentage of participants
|
SECONDARY outcome
Timeframe: 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)
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.
Outcome measures
| Measure |
Group A: Sculptra Aesthetic
n=39 Participants
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.
|
Group B: No Treatment
n=66 Participants
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.
|
|---|---|---|
|
Percentage of Participants With At Least "Improved" on the GAIS Based on the Investigator Live Assessment
At Month 19
|
97.2 Percentage of participants
|
97.0 Percentage of participants
|
|
Percentage of Participants With At Least "Improved" on the GAIS Based on the Investigator Live Assessment
At Month 21
|
97.4 Percentage of participants
|
96.9 Percentage of participants
|
|
Percentage of Participants With At Least "Improved" on the GAIS Based on the Investigator Live Assessment
At Month 24
|
92.3 Percentage of participants
|
93.8 Percentage of participants
|
SECONDARY outcome
Timeframe: 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)
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Outcome measures
| Measure |
Group A: Sculptra Aesthetic
n=39 Participants
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.
|
Group B: No Treatment
n=67 Participants
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.
|
|---|---|---|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
At Month 19 · Excellent
|
8 Participants
|
14 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
At Month 19 · Very good
|
8 Participants
|
14 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
At Month 19 · Good
|
10 Participants
|
21 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
At Month 19 · Satisfactory
|
8 Participants
|
13 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
At Month 19 · Not satisfied
|
2 Participants
|
5 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
At Month 21 · Excellent
|
6 Participants
|
16 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
At Month 21 · Very good
|
12 Participants
|
13 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
At Month 21 · Good
|
11 Participants
|
17 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
At Month 21 · Satisfactory
|
6 Participants
|
18 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
At Month 21 · Not satisfied
|
3 Participants
|
1 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
At Month 24 · Excellent
|
7 Participants
|
14 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
At Month 24 · Very good
|
14 Participants
|
12 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
At Month 24 · Good
|
10 Participants
|
21 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
At Month 24 · Satisfactory
|
5 Participants
|
11 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
At Month 24 · Not satisfied
|
3 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 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)
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Outcome measures
| Measure |
Group A: Sculptra Aesthetic
n=39 Participants
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.
|
Group B: No Treatment
n=67 Participants
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.
|
|---|---|---|
|
Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
At Month 19 · Excellent
|
7 Participants
|
14 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
At Month 19 · Very Good
|
9 Participants
|
18 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
At Month 19 · Good
|
11 Participants
|
19 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
At Month 19 · Satisfactory
|
7 Participants
|
13 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
At Month 19 · Not Satisfied
|
2 Participants
|
3 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
At Month 21 · Excellent
|
6 Participants
|
16 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
At Month 21 · Very Good
|
11 Participants
|
14 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
At Month 21 · Good
|
12 Participants
|
17 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
At Month 21 · Satisfactory
|
7 Participants
|
15 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
At Month 21 · Not Satisfied
|
2 Participants
|
3 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
At Month 24 · Excellent
|
7 Participants
|
15 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
At Month 24 · Very Good
|
17 Participants
|
13 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
At Month 24 · Good
|
8 Participants
|
19 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
At Month 24 · Satisfactory
|
4 Participants
|
13 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
At Month 24 · Not Satisfied
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 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)
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Outcome measures
| Measure |
Group A: Sculptra Aesthetic
n=39 Participants
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.
|
Group B: No Treatment
n=67 Participants
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.
|
|---|---|---|
|
Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
At Month 19 · Excellent
|
5 Participants
|
14 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
At Month 19 · Very good
|
10 Participants
|
17 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
At Month 19 · Good
|
12 Participants
|
17 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
At Month 19 · Satisfactory
|
7 Participants
|
16 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
At Month 19 · Not Satisfied
|
2 Participants
|
3 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
At Month 21 · Excellent
|
6 Participants
|
15 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
At Month 21 · Very good
|
9 Participants
|
15 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
At Month 21 · Good
|
12 Participants
|
16 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
At Month 21 · Satisfactory
|
7 Participants
|
15 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
At Month 21 · Not Satisfied
|
4 Participants
|
4 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
At Month 24 · Excellent
|
7 Participants
|
14 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
At Month 24 · Very good
|
14 Participants
|
12 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
At Month 24 · Good
|
10 Participants
|
21 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
At Month 24 · Satisfactory
|
5 Participants
|
11 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
At Month 24 · Not Satisfied
|
3 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 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)
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Outcome measures
| Measure |
Group A: Sculptra Aesthetic
n=39 Participants
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.
|
Group B: No Treatment
n=67 Participants
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.
|
|---|---|---|
|
Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
At Month 19 · Excellent
|
4 Participants
|
16 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
At Month 19 · Very Good
|
14 Participants
|
14 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
At Month 19 · Good
|
9 Participants
|
20 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
At Month 19 · Satisfactory
|
7 Participants
|
12 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
At Month 19 · Not Satisfied
|
2 Participants
|
5 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
At Month 21 · Excellent
|
7 Participants
|
16 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
At Month 21 · Very Good
|
9 Participants
|
16 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
At Month 21 · Good
|
14 Participants
|
16 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
At Month 21 · Satisfactory
|
5 Participants
|
13 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
At Month 21 · Not Satisfied
|
3 Participants
|
4 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
At Month 24 · Excellent
|
7 Participants
|
15 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
At Month 24 · Very Good
|
15 Participants
|
13 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
At Month 24 · Good
|
10 Participants
|
20 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
At Month 24 · Satisfactory
|
3 Participants
|
10 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
At Month 24 · Not Satisfied
|
4 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 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)
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Outcome measures
| Measure |
Group A: Sculptra Aesthetic
n=39 Participants
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.
|
Group B: No Treatment
n=67 Participants
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.
|
|---|---|---|
|
Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
At Month 19 · Good
|
12 Participants
|
19 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
At Month 19 · Satisfactory
|
7 Participants
|
14 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
At Month 19 · Not Satisfied
|
2 Participants
|
5 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
At Month 24 · Good
|
11 Participants
|
20 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
At Month 24 · Satisfactory
|
5 Participants
|
15 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
At Month 24 · Not Satisfied
|
3 Participants
|
4 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
At Month 19 · Excellent
|
3 Participants
|
15 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
At Month 19 · Very good
|
12 Participants
|
14 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
At Month 21 · Excellent
|
5 Participants
|
16 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
At Month 21 · Very good
|
10 Participants
|
13 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
At Month 21 · Good
|
13 Participants
|
15 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
At Month 21 · Satisfactory
|
6 Participants
|
17 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
At Month 21 · Not Satisfied
|
4 Participants
|
4 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
At Month 24 · Excellent
|
7 Participants
|
13 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
At Month 24 · Very good
|
13 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 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)
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Outcome measures
| Measure |
Group A: Sculptra Aesthetic
n=39 Participants
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.
|
Group B: No Treatment
n=67 Participants
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.
|
|---|---|---|
|
Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
At Month 19 · Excellent
|
6 Participants
|
13 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
At Month 19 · Satisfactory
|
5 Participants
|
18 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
At Month 19 · Not Satisfied
|
3 Participants
|
4 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
At Month 21 · Excellent
|
4 Participants
|
16 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
At Month 21 · Very good
|
11 Participants
|
13 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
At Month 21 · Good
|
14 Participants
|
13 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
At Month 21 · Satisfactory
|
5 Participants
|
18 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
At Month 21 · Not Satisfied
|
4 Participants
|
5 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
At Month 24 · Excellent
|
7 Participants
|
13 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
At Month 24 · Very good
|
13 Participants
|
16 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
At Month 24 · Good
|
11 Participants
|
16 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
At Month 24 · Satisfactory
|
5 Participants
|
14 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
At Month 24 · Not Satisfied
|
3 Participants
|
6 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
At Month 19 · Very good
|
11 Participants
|
14 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
At Month 19 · Good
|
11 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 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)
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Outcome measures
| Measure |
Group A: Sculptra Aesthetic
n=39 Participants
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.
|
Group B: No Treatment
n=67 Participants
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.
|
|---|---|---|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?
At Month 19 · Excellent
|
9 Participants
|
14 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?
At Month 19 · Very good
|
12 Participants
|
20 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?
At Month 19 · Good
|
7 Participants
|
17 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?
At Month 19 · Satisfactory
|
5 Participants
|
12 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?
At Month 19 · Not Satisfied
|
3 Participants
|
4 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?
At Month 21 · Excellent
|
6 Participants
|
17 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?
At Month 21 · Very good
|
14 Participants
|
14 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?
At Month 21 · Good
|
10 Participants
|
17 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?
At Month 21 · Satisfactory
|
5 Participants
|
14 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?
At Month 21 · Not Satisfied
|
3 Participants
|
3 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?
At Month 24 · Excellent
|
7 Participants
|
17 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?
At Month 24 · Very good
|
14 Participants
|
10 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?
At Month 24 · Good
|
11 Participants
|
21 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?
At Month 24 · Satisfactory
|
4 Participants
|
10 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?
At Month 24 · Not Satisfied
|
3 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 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)
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Outcome measures
| Measure |
Group A: Sculptra Aesthetic
n=39 Participants
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.
|
Group B: No Treatment
n=67 Participants
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.
|
|---|---|---|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?
At Month 19 · Excellent
|
7 Participants
|
14 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?
At Month 19 · Very good
|
9 Participants
|
18 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?
At Month 19 · Good
|
11 Participants
|
19 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?
At Month 19 · Satisfactory
|
7 Participants
|
13 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?
At Month 19 · Not Satisfied
|
2 Participants
|
3 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?
At Month 21 · Excellent
|
6 Participants
|
19 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?
At Month 21 · Very good
|
12 Participants
|
12 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?
At Month 21 · Good
|
11 Participants
|
14 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?
At Month 21 · Satisfactory
|
6 Participants
|
16 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?
At Month 21 · Not Satisfied
|
3 Participants
|
4 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?
At Month 24 · Excellent
|
6 Participants
|
18 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?
At Month 24 · Very good
|
14 Participants
|
11 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?
At Month 24 · Good
|
12 Participants
|
19 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?
At Month 24 · Satisfactory
|
4 Participants
|
11 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?
At Month 24 · Not Satisfied
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 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)
A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.
Outcome measures
| Measure |
Group A: Sculptra Aesthetic
n=39 Participants
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.
|
Group B: No Treatment
n=67 Participants
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.
|
|---|---|---|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?
At Month 19 · Very good
|
8 Participants
|
13 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?
At Month 19 · Good
|
13 Participants
|
17 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?
At Month 19 · Satisfactory
|
4 Participants
|
13 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?
At Month 19 · Not Satisfied
|
4 Participants
|
10 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?
At Month 21 · Excellent
|
4 Participants
|
16 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?
At Month 21 · Very good
|
13 Participants
|
16 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?
At Month 21 · Good
|
11 Participants
|
15 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?
At Month 21 · Satisfactory
|
6 Participants
|
12 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?
At Month 19 · Excellent
|
7 Participants
|
14 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?
At Month 21 · Not Satisfied
|
4 Participants
|
6 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?
At Month 24 · Excellent
|
7 Participants
|
16 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?
At Month 24 · Very good
|
12 Participants
|
11 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?
At Month 24 · Good
|
11 Participants
|
20 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?
At Month 24 · Satisfactory
|
5 Participants
|
10 Participants
|
|
Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?
At Month 24 · Not Satisfied
|
4 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 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)
A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Outcome measures
| Measure |
Group A: Sculptra Aesthetic
n=39 Participants
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.
|
Group B: No Treatment
n=67 Participants
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.
|
|---|---|---|
|
Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?
At Month 19 · Excellent
|
8 Participants
|
18 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?
At Month 19 · Very good
|
10 Participants
|
14 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?
At Month 19 · Satisfactory
|
6 Participants
|
17 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?
At Month 19 · Not satisfied
|
2 Participants
|
5 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?
At Month 21 · Excellent
|
7 Participants
|
17 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?
At Month 21 · Very good
|
12 Participants
|
11 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?
At Month 21 · Good
|
10 Participants
|
19 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?
At Month 21 · Satisfactory
|
6 Participants
|
14 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?
At Month 21 · Not satisfied
|
3 Participants
|
4 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?
At Month 19 · Good
|
10 Participants
|
13 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?
At Month 24 · Excellent
|
7 Participants
|
18 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?
At Month 24 · Very good
|
15 Participants
|
9 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?
At Month 24 · Good
|
9 Participants
|
20 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?
At Month 24 · Satisfactory
|
5 Participants
|
13 Participants
|
|
Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?
At Month 24 · Not satisfied
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 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)
A 5-point subject satisfaction questionnaire with the following responses: Strongly agree, Agree, Neither agree or Disagree, Disagree, Strongly disagree.
Outcome measures
| Measure |
Group A: Sculptra Aesthetic
n=39 Participants
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.
|
Group B: No Treatment
n=67 Participants
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.
|
|---|---|---|
|
Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?
At Month 19 · Agree
|
10 Participants
|
20 Participants
|
|
Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?
At Month 19 · Neither Agree or Disagree
|
4 Participants
|
10 Participants
|
|
Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?
At Month 19 · Disagree
|
0 Participants
|
0 Participants
|
|
Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?
At Month 19 · Strongly Disagree
|
0 Participants
|
0 Participants
|
|
Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?
At Month 21 · Strongly agree
|
21 Participants
|
35 Participants
|
|
Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?
At Month 21 · Agree
|
13 Participants
|
25 Participants
|
|
Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?
At Month 21 · Neither Agree or Disagree
|
4 Participants
|
5 Participants
|
|
Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?
At Month 21 · Disagree
|
0 Participants
|
0 Participants
|
|
Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?
At Month 21 · Strongly Disagree
|
0 Participants
|
0 Participants
|
|
Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?
At Month 24 · Strongly agree
|
21 Participants
|
34 Participants
|
|
Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?
At Month 24 · Neither Agree or Disagree
|
3 Participants
|
7 Participants
|
|
Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?
At Month 24 · Disagree
|
0 Participants
|
0 Participants
|
|
Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?
At Month 19 · Strongly agree
|
22 Participants
|
37 Participants
|
|
Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?
At Month 24 · Agree
|
15 Participants
|
24 Participants
|
|
Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?
At Month 24 · Strongly Disagree
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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)
A 5-point subject satisfaction questionnaire with the following responses: Strongly agree, Agree, Neither Agree or Disagree, Disagree, Strongly Disagree.
Outcome measures
| Measure |
Group A: Sculptra Aesthetic
n=39 Participants
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.
|
Group B: No Treatment
n=67 Participants
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.
|
|---|---|---|
|
Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?
At Month 19 · Strongly agree
|
17 Participants
|
30 Participants
|
|
Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?
At Month 19 · Agree
|
13 Participants
|
21 Participants
|
|
Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?
At Month 19 · Neither agree or Disagree
|
6 Participants
|
11 Participants
|
|
Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?
At Month 19 · Disagree
|
0 Participants
|
4 Participants
|
|
Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?
At Month 24 · Strongly agree
|
16 Participants
|
28 Participants
|
|
Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?
At Month 24 · Agree
|
19 Participants
|
25 Participants
|
|
Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?
At Month 24 · Neither agree or Disagree
|
3 Participants
|
9 Participants
|
|
Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?
At Month 19 · Strongly disagree
|
0 Participants
|
1 Participants
|
|
Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?
At Month 21 · Strongly agree
|
17 Participants
|
27 Participants
|
|
Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?
At Month 21 · Agree
|
15 Participants
|
29 Participants
|
|
Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?
At Month 21 · Neither agree or Disagree
|
6 Participants
|
6 Participants
|
|
Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?
At Month 21 · Disagree
|
0 Participants
|
3 Participants
|
|
Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?
At Month 21 · Strongly disagree
|
0 Participants
|
0 Participants
|
|
Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?
At Month 24 · Disagree
|
1 Participants
|
2 Participants
|
|
Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?
At Month 24 · Strongly disagree
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 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)
A subject satisfaction question with responses Yes or No.
Outcome measures
| Measure |
Group A: Sculptra Aesthetic
n=39 Participants
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.
|
Group B: No Treatment
n=67 Participants
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.
|
|---|---|---|
|
Subject Satisfaction: Would You Recommend the Treatment to a Friend?
At Month 19 · Yes
|
34 Participants
|
56 Participants
|
|
Subject Satisfaction: Would You Recommend the Treatment to a Friend?
At Month 19 · No
|
2 Participants
|
11 Participants
|
|
Subject Satisfaction: Would You Recommend the Treatment to a Friend?
At Month 21 · Yes
|
35 Participants
|
58 Participants
|
|
Subject Satisfaction: Would You Recommend the Treatment to a Friend?
At Month 21 · No
|
3 Participants
|
7 Participants
|
|
Subject Satisfaction: Would You Recommend the Treatment to a Friend?
At Month 24 · Yes
|
35 Participants
|
55 Participants
|
|
Subject Satisfaction: Would You Recommend the Treatment to a Friend?
At Month 24 · No
|
4 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 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)
A subject satisfaction question with responses Yes or No.
Outcome measures
| Measure |
Group A: Sculptra Aesthetic
n=39 Participants
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.
|
Group B: No Treatment
n=67 Participants
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.
|
|---|---|---|
|
Subject Satisfaction: Would You do the Treatment Again?
At Month 24 · Yes
|
34 Participants
|
55 Participants
|
|
Subject Satisfaction: Would You do the Treatment Again?
At Month 24 · No
|
5 Participants
|
10 Participants
|
|
Subject Satisfaction: Would You do the Treatment Again?
At Month 19 · Yes
|
31 Participants
|
55 Participants
|
|
Subject Satisfaction: Would You do the Treatment Again?
At Month 19 · No
|
5 Participants
|
12 Participants
|
|
Subject Satisfaction: Would You do the Treatment Again?
At Month 21 · Yes
|
32 Participants
|
58 Participants
|
|
Subject Satisfaction: Would You do the Treatment Again?
At Month 21 · No
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 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)
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.
Outcome measures
| Measure |
Group A: Sculptra Aesthetic
n=39 Participants
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.
|
Group B: No Treatment
n=67 Participants
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.
|
|---|---|---|
|
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
|
34.9 score on a scale
Standard Deviation 37.0
|
|
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
|
36.8 score on a scale
Standard Deviation 30.69
|
|
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
|
38.7 score on a scale
Standard Deviation 27.98
|
SECONDARY outcome
Timeframe: 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)
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.
Outcome measures
| Measure |
Group A: Sculptra Aesthetic
n=39 Participants
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.
|
Group B: No Treatment
n=72 Participants
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.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
TEAEs
|
17 Participants
|
15 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Serious TEAEs
|
0 Participants
|
1 Participants
|
Adverse Events
Group A: Sculptra Aesthetic
Group B: No Treatment
Serious adverse events
| Measure |
Group A: Sculptra Aesthetic
n=39 participants at risk
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.
|
Group B: No Treatment
n=72 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/39 • From start of study drug administration up to end of the study (up to Month 24)
The extension population included all participants entering the extension study.
|
1.4%
1/72 • From start of study drug administration up to end of the study (up to Month 24)
The extension population included all participants entering the extension study.
|
Other adverse events
| Measure |
Group A: Sculptra Aesthetic
n=39 participants at risk
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.
|
Group B: No Treatment
n=72 participants at risk
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.
|
|---|---|---|
|
General disorders
Injection site bruising
|
12.8%
5/39 • From start of study drug administration up to end of the study (up to Month 24)
The extension population included all participants entering the extension study.
|
0.00%
0/72 • From start of study drug administration up to end of the study (up to Month 24)
The extension population included all participants entering the extension study.
|
|
General disorders
Injection site pain
|
5.1%
2/39 • From start of study drug administration up to end of the study (up to Month 24)
The extension population included all participants entering the extension study.
|
0.00%
0/72 • From start of study drug administration up to end of the study (up to Month 24)
The extension population included all participants entering the extension study.
|
|
Infections and infestations
Sinusitis
|
5.1%
2/39 • From start of study drug administration up to end of the study (up to Month 24)
The extension population included all participants entering the extension study.
|
0.00%
0/72 • From start of study drug administration up to end of the study (up to Month 24)
The extension population included all participants entering the extension study.
|
|
Infections and infestations
COVID-19
|
0.00%
0/39 • From start of study drug administration up to end of the study (up to Month 24)
The extension population included all participants entering the extension study.
|
5.6%
4/72 • From start of study drug administration up to end of the study (up to Month 24)
The extension population included all participants entering the extension study.
|
|
Social circumstances
Postmenopause
|
5.1%
2/39 • From start of study drug administration up to end of the study (up to Month 24)
The extension population included all participants entering the extension study.
|
0.00%
0/72 • From start of study drug administration up to end of the study (up to Month 24)
The extension population included all participants entering the extension study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER